CGM Initiation Research Articles

571-P: Theory-Based Design of a Nutrition-Focused Approach at CGM Initiation for People with T2D

Background: CGM can improve glycemic outcomes and has the potential to help people with T2D adopt evidence-based nutrition recommendations. Effective interventions using CGM data to guide food choices that align with nutrition recommendations are sparse. The objective of this work is to describe development of a nutrition-focused approach (NFA) at CGM initiation using the behavior change wheel (BCW), a theory-based intervention development framework. Methods: The BCW process included 3 parts: 1) specifying the target behavior and existing barriers according to the Capability Opportunity Motivation-Behavior (COM-B) Model and Theoretical Domains Framework (TDF); 2) identifying intervention content to address the barriers (e.g. broad strategies for behavior change and specific behavior change techniques (BCTs)); and 3) assessing feasibility of the intervention and selecting ways to implement content. Rapid literature review, stakeholder discussion, and content analysis were used to achieve these steps. Results: The target behavior was defined as using CGM data to guide dietary changes that align with current nutrition recommendations and improve TIR. Via content analysis, 80 barriers were coded according to the COM-B and TDF constructs. After feasibility assessment and stakeholder discussions, 12 barriers were selected (e.g. an opportunity barrier is lack of tools supporting use of CGM data to guide food choices). These barriers were mapped to 5 behavior change strategies (i.e. intervention functions; such as training and enablement) and associated BCTs (e.g. habit formation and reframing). The final intervention includes three components: a 1-hr in-person session, a 30-min telehealth session, and nutrition-focused CGM-initiation materials. Conclusion: Use of the BCW led to the development of a rigorous but pragmatic theory-driven intervention. Effectiveness of the nutrition-focused approach at CGM initiation intervention will be tested in clinical trials. Disclosure H.Willis: Other Relationship; Abbott Diabetes, Dexcom, Inc., Research Support; Abbott Diabetes. M.Jaka: None. E.A.Johnson: Speaker's Bureau; Medtronic, Medscape. Funding American Diabetes Association (7-22-JDFN-27 to H.W.)

17-OR: ADA Presidents' Select Abstract: CGM Initiation within Six Months of T1D Diagnosis Associated with Lower HbA1c at 3 Years

Background: Early initiation of CGM after T1D diagnosis has been associated with lower HbA1c in the years following diagnosis in single-institution studies. This multi-institution study evaluated the association between the timing of CGM initiation and HbA1c at 3 years post-diagnosis. Methods: Data were obtained from the T1D Exchange QI Collaborative, representing 52 centers across the US. Of the 33,942 youth ≤18 years with T1D >12 months in the Collaborative data set, those who started CGM within 12 months of diagnosis were included. LOESS plots evaluated the relationship between timing of CGM initiation and HbA1c. Results: Of the 5,339 youth included in this analysis, median age was 9 (IQR 6) and 26% had public health insurance. Initiation of CGM occurred within 3-months of diagnosis for 43%, between 3-6 months for 27%, and 6-12 months for 30%. There was no significant difference in CGM initiation based on insurance or the social construct of self-identified race and ethnicity, used as an indicator of systemic racism. Median HbA1c at 3 years was lower for those who initiated CGM within 3 months and between 3-6 months of diagnosis compared to those starting CGM at 6-12 months (7.3 ± 1.7 and 7.5 ± 1.7 vs. 7.9 ± 1.7; Figure 1). Conclusion: In summary, early initiation of CGM within the first 6 months of diagnosis is related to improved A1c outcomes at 3 years post-diagnosis. Disclosure E.A.Mann: None. P.Gomez: None. O.Ebekozien: Advisory Panel; Medtronic, Research Support; Eli Lilly and Company, Dexcom, Inc. P.Prahalad: None. S.Rompicherla: None. N.Noor: None. B.Miyazaki: None. L.Golden: None. J.Sarhis: None. H.K.Akturk: Advisory Panel; Senseonics, MannKind Corporation, Research Support; Medtronic, Tandem Diabetes Care, Inc., Dexcom, Inc., REMD Biotherapeutics, Eli Lilly and Company, IM Therapeutics. J.M.Lee: Advisory Panel; GoodRx, Consultant; Tandem Diabetes Care, Inc. D.Desalvo: Consultant; Dexcom, Inc., Research Support; Insulet Corporation.

1127-P: 4T Study—Early CGM Initiation and Tighter Glucose Targets Improves A1C in Youth with T1D

Methods to optimize care after T1D diagnosis are needed. We hypothesized lowering A1c targets to <7% would further lower A1c in the 4T Study in which CGM with asynchronous remote patient monitoring (RPM) is initiated after T1D diagnosis. All youth with newly diagnosed T1D (June 2020-March 2022) were offered CGM and RPM after diagnosis (Study 1, n=133). We compared A1c at 1-year in Study 1 with the 4T Pilot (2018-20) and Historical cohorts (2014-16). We visualized population-based A1c trajectories using locally estimated scatter plot smoothing (Fig) and % meeting A1c targets. Mean A1c at diagnosis was similar in Pilot (12.2%±2.1%) and Study 1 (12.2±2.4%) and higher than the Historical cohort (10.7±2.5%). In Study 1, the median age of diagnosis was 10.8 years, 55% male, 40% non-Hispanic White, and 38% with public insurance. CGM initiation occurred within 30 days of diagnosis in 98.5%. At 3, 6, 9, and 12 months post-diagnosis, the Study 1 cohort had LOESS-based mean A1c differences of 0.16%, 0.24%, 0.31%, and 0.58% lower than the Pilot and 0.04%, 0.60%, 0.83%, and 1.06% lower than the Historical cohort. A1c target <7% was met by 61% of youth in Study 1, 51% in the Pilot and 28% in the Historical cohort. Time <70mg/dl was ≤2.3%. The 4T program which emphasizes early CGM initiation, RPM, tighter glucose targets, and consistent team messaging was associated with lower A1c. These data support implementation of the 4T program in youth with T1D. Disclosure P.Prahalad: None. D.M.Maahs: Advisory Panel; Medtronic, LifeScan Diabetes Institute, MannKind Corporation, Consultant; Abbott, Research Support; Dexcom, Inc. 4t study group: n/a. V.Ding: None. D.P.Zaharieva: Advisory Panel; Dexcom, Inc., Research Support; Hemsley Charitable Trust, International Society for Pediatric and Adolescent Diabetes, Insulet Corporation, Speaker's Bureau; American Diabetes Association, Ascensia Diabetes Care, Medtronic. A.Addala: None. F.K.Bishop: None. D.Scheinker: None. R.Johari: None. M.Desai: None. K.K.Hood: Consultant; Cecelia Health. Funding National Institutes of Health (P30DK116074), (R18DK122422 to D.M.M.); Dexcom, Inc.; Lucile Packard Children’s Hospital Auxiliaries Endowment; Stanford Maternal and Child Health Research Institute

1165-P: 4T Study—Changing Clinical Processes Increases Technology Use at T1D Diagnosis

Use of diabetes technology (CGM, pump) is recommended for people with T1D, and early CGM initiation leads to improved glucose values. We compare %CGM and %pump use and time to initiation from T1D diagnosis in the Historical cohort, 4T Pilot, and 4T Study 1 and the associated workflow changes to increase early technology use. CGM initiation within 30 days of diagnosis increased from 2% in the historical cohort to 92% in Pilot 4T to 98% in 4T Study 1 (Table). Days to pump initiation from TID diagnosis decreased from 272 in the historical cohort to 144 days in Study 1. From 2014-2016 pumps and CGM were initiated when families expressed interest or if the provider discussed them. Families were required to attend a pre-pump class where the CDCES introduced pumps and CGMs prior to starting technology. During the 4T Pilot and 4T Study 1, CGMs were introduced and started during the first month of diagnosis. In Study 1, families were encouraged to attend pump class and initiate AID. The CDCES team does the CGM teach, CGM follow-up, pre-pump classes, and insulin pump starts for the families in preferred language. In 4T Study 2 (enrolling) standard of care is to complete a pre-pump class in the first 3 months after diagnosis. Changes in processes can lead to early implementation of diabetes technology. A structured, team-based process to introduce, reduce barriers, and encourage families to utilize diabetes technology increases early initiation. Disclosure B.P.Conrad: Advisory Panel; Edgepark medical supplies, Consultant; Abbott Diabetes. P.Prahalad: None. D.M.Maahs: Advisory Panel; Medtronic, LifeScan Diabetes Institute, MannKind Corporation, Consultant; Abbott, Research Support; Dexcom, Inc. F.K.Bishop: None. J.Leverenz: None. A.Chmielewski: None. P.Sagan: None. J.Senaldi: None. A.Martinez-singh: None. S.Lin: None. I.Chan: None. Funding National Institute of Diabetes and Digestive and Kidney Diseases (R18DK122422); The Leona M. and Harry B. Helmsley Charitable Trust (G-2002-04251-2); International Society for Pediatric and Adolescent Diabetes/JDRF (1P30DK, 11607401); Lucile Packard Child

1031-P: Virtual Clinic Support—Patient-Reported Outcome Benefits

Behavioral health support can benefit those living with diabetes, but there is limited information on patient reported outcomes (PROs) associated with a virtual clinic. Adults with diabetes (n=234) received virtual care including support for CGM initiation and management over a 6-month study period. Care was led by a CDCES with support from a behavioral team. Participants completed PROs surveys 1) at baseline and 6 months to evaluate change and 2) each month on diabetes distress (DD), fear of hypoglycemia (FOH), and depression (DEP). Full list of PROs surveys included in table. A positive screen led to recommendation for a brief behavioral intervention. Participants with T1D (n=160) were 44(±14) years and mean baseline A1c of 7.8%. Participants with T2D (n=74) were 55(±12) years and mean baseline A1c of 8.1%. Participants screened positive for DD, FOH, or DEP 67% of the time with FOH as the most common concern. Of those with a positive screen, 70% of T1D and 59% of T2D participants had at least one behavioral team contact. Virtual clinic care was associated with a benefit on 7 of 9 PROs for T1D and 7 of 9 PROs for T2D (p values < 0.05; see table). For these virtual clinic adults with diabetes, PROs improved 78% of the time with noteworthy benefits of less FOH, less DD, and more glucose monitoring satisfaction. Paired with the glycemic improvements observed in this virtual clinic study, there were robust benefits on the quality of life of adults with diabetes. Disclosure K.K.Hood: Consultant; Cecelia Health. S.Oser: Advisory Panel; Cecelia Health, Dexcom, Inc., Consultant; Medscape, Research Support; Abbott Diabetes. T.Oser: Advisory Panel; Cecelia Health, Consultant; Dexcom, Inc., Medscape, Research Support; Abbott. D.Raghinaru: None. Z.Thompson: None. R.S.Weinstock: Consultant; Jaeb Center for Health Research, Other Relationship; Wolters Kluwer Health, Research Support; Insulet Corporation, Medtronic, Eli Lilly and Company, Novo Nordisk, Boehringer Ingelheim Inc., Hemsley Charitable Trust, National Institute of Diabetes and Digestive and Kidney Diseases, Tandem Diabetes Care, Inc., Kowa Pharmaceuticals America, Inc. R.Beck: Consultant; Eli Lilly and Company, Novo Nordisk, Diasome, Insulet Corporation, Research Support; Tandem Diabetes Care, Inc., Beta Bionics, Inc., Dexcom, Inc., Bigfoot Biomedical, Inc., Medtronic, Ascensia Diabetes Care, Roche Diabetes Care, Eli Lilly and Company, Novo Nordisk. G.Aleppo: Advisory Panel; Medscape, Consultant; Bayer Inc., Insulet Corporation, Research Support; Dexcom, Inc., Eli Lilly and Company, Emmes, Insulet Corporation, Fractyl Health, Inc., WellDoc, Speaker's Bureau; Dexcom, Inc. R.M.Bergenstal: Advisory Panel; Abbott Diabetes, Eli Lilly and Company, Medtronic, Novo Nordisk, Roche Diabetes Care, Zealand Pharma A/S, Consultant; Ascensia Diabetes Care, Bigfoot Biomedical, Inc., CeQur SA, Dexcom, Inc., Hygieia, Onduo LLC, Sanofi, Vertex Pharmaceuticals Incorporated, Research Support; Abbott Diabetes, Dexcom, Inc., Eli Lilly and Company, Insulet Corporation, Medtronic, Novo Nordisk, Sanofi, UnitedHealth Group. T.L.Cushman: None. R.L.Gal: None. C.Kollman: Research Support; Insulet Corporation, Dexcom, Inc., Tandem Diabetes Care, Inc. D.F.Kruger: Advisory Panel; Abbott Diabetes, Lilly, Medtronic, Novo Nordisk, Research Support; Dexcom, Inc., Beta Bionics, Inc., Speaker's Bureau; Dexcom, Inc., Lilly, Xeris Pharmaceuticals, Inc., Novo Nordisk. M.L.Johnson: Research Support; Abbott, Lilly, Insulet Corporation, NIH - National Institutes of Health, Patient-Centered Outcomes Research Institute, Novo Nordisk, Tandem Diabetes Care, Inc., Medtronic, Hemsley Charitable Trust, Jaeb Center for Health Research. T.S.Mcarthur: None. B.A.Olson: Stock/Shareholder; Abbott. Funding The Leona M. and Harry B. Helmsley Charitable Trust; Dexcom, Inc.

63-LB: Real-Time Continuous Glucose Monitoring (rtCGM) Is Associated with Improved Clinical and Psychosocial Health in People with Type 2 Diabetes on Basal Insulin (T2D-BI)

Background and Aims: Introduction of basal insulin (BI) can be an intimidating treatment escalation due to increased risk of hypoglycemia and weight gain for people with type 2 diabetes (T2D). There is growing evidence supporting the glycemic and quality of life benefits of rtCGM in T2D. We analyzed survey and rtCGM data for T2D-BI users of the Dexcom G6 rtCGM system to investigate the impact on sensor metrics, self-reported body weight, and psychosocial health. Methods: Three hundred T2D-BI Dexcom G6 users completed online surveys regarding their demographics and diabetes health. Participants’ sensor metrics were analyzed for duration of wear and glycemic changes from CGM initiation onwards (14-day time periods with ≥70% data available). Changes in variables were evaluated for clinical significance (weight loss ≥5%, transition to A1C <7%, ΔTIR ≥5%) and statistical significance (p<0.05 from paired t-tests). Results: Data from 150 CGM-naïve (prior to Dexcom G6 initiation) T2D-BI users were analyzed. Mean (IQR) age=60 years (53, 70), 45% female, 81% White, 50% reported annual household income <$75K. CGM duration was 11 months (4, 13). Body weight at baseline=235 pounds (190, 270), A1C=8.4% (7, 9.3), TIR= 69% (58, 86). Reported weight loss averaged 13 (-20, 0) pounds, A1C decrease averaged 1.6 (-2.5, 0) percentage points (both p<0.001) with no increase in hypoglycemia. Overall, 53 users experienced clinically significant weight loss (5% of total body weight), 48 improved their A1C to <7%, and 46 improved TIR by ≥ 5%. Participants reported healthier eating patterns, simplified diabetes management routines, and increased peace of mind using Dexcom G6. Conclusions: These real-world outcomes demonstrate clinically valuable improvements in T2D-BI on Dexcom G6 with respect to glycemic control, body weight, diabetes behaviors, and psychosocial health. Disclosure M. A. Crawford: Employee; Dexcom, Inc. C. Hicks: Employee; Dexcom, Inc. T. Zhou: Employee; Pfizer Inc. A. Kleinhanzl: Employee; Dexcom, Inc. H. Singh: Employee; Tandem Diabetes Care, Inc., Dexcom, Inc.

Disparities in Hemoglobin A1c Levels in the First Year After Diagnosis Among Youths With Type 1 Diabetes Offered Continuous Glucose Monitoring

Continuous glucose monitoring (CGM) is associated with improvements in hemoglobin A1c (HbA1c) in youths with type 1 diabetes (T1D); however, youths from minoritized racial and ethnic groups and those with public insurance face greater barriers to CGM access. Early initiation of and access to CGM may reduce disparities in CGM uptake and improve diabetes outcomes. To determine whether HbA1c decreases differed by ethnicity and insurance status among a cohort of youths newly diagnosed with T1D and provided CGM. This cohort study used data from the Teamwork, Targets, Technology, and Tight Control (4T) study, a clinical research program that aims to initiate CGM within 1 month of T1D diagnosis. All youths with new-onset T1D diagnosed between July 25, 2018, and June 15, 2020, at Stanford Children's Hospital, a single-site, freestanding children's hospital in California, were approached to enroll in the Pilot-4T study and were followed for 12 months. Data analysis was performed and completed on June 3, 2022. All eligible participants were offered CGM within 1 month of diabetes diagnosis. To assess HbA1c change over the study period, analyses were stratified by ethnicity (Hispanic vs non-Hispanic) or insurance status (public vs private) to compare the Pilot-4T cohort with a historical cohort of 272 youths diagnosed with T1D between June 1, 2014, and December 28, 2016. The Pilot-4T cohort comprised 135 youths, with a median age of 9.7 years (IQR, 6.8-12.7 years) at diagnosis. There were 71 boys (52.6%) and 64 girls (47.4%). Based on self-report, participants' race was categorized as Asian or Pacific Islander (19 [14.1%]), White (62 [45.9%]), or other race (39 [28.9%]); race was missing or not reported for 15 participants (11.1%). Participants also self-reported their ethnicity as Hispanic (29 [21.5%]) or non-Hispanic (92 [68.1%]). A total of 104 participants (77.0%) had private insurance and 31 (23.0%) had public insurance. Compared with the historical cohort, similar reductions in HbA1c at 6, 9, and 12 months postdiagnosis were observed for Hispanic individuals (estimated difference, -0.26% [95% CI, -1.05% to 0.43%], -0.60% [-1.46% to 0.21%], and -0.15% [-1.48% to 0.80%]) and non-Hispanic individuals (estimated difference, -0.27% [95% CI, -0.62% to 0.10%], -0.50% [-0.81% to -0.11%], and -0.47% [-0.91% to 0.06%]) in the Pilot-4T cohort. Similar reductions in HbA1c at 6, 9, and 12 months postdiagnosis were also observed for publicly insured individuals (estimated difference, -0.52% [95% CI, -1.22% to 0.15%], -0.38% [-1.26% to 0.33%], and -0.57% [-2.08% to 0.74%]) and privately insured individuals (estimated difference, -0.34% [95% CI, -0.67% to 0.03%], -0.57% [-0.85% to -0.26%], and -0.43% [-0.85% to 0.01%]) in the Pilot-4T cohort. Hispanic youths in the Pilot-4T cohort had higher HbA1c at 6, 9, and 12 months postdiagnosis than non-Hispanic youths (estimated difference, 0.28% [95% CI, -0.46% to 0.86%], 0.63% [0.02% to 1.20%], and 1.39% [0.37% to 1.96%]), as did publicly insured youths compared with privately insured youths (estimated difference, 0.39% [95% CI, -0.23% to 0.99%], 0.95% [0.28% to 1.45%], and 1.16% [-0.09% to 2.13%]). The findings of this cohort study suggest that CGM initiation soon after diagnosis is associated with similar improvements in HbA1c for Hispanic and non-Hispanic youths as well as for publicly and privately insured youths. These results further suggest that equitable access to CGM soon after T1D diagnosis may be a first step to improve HbA1c for all youths but is unlikely to eliminate disparities entirely. ClinicalTrials.gov Identifier: NCT04336969.

954-P: Barriers to Enrollment in a Continuous Glucose Monitoring Pilot Program for Medicaid Patients

Background: CGM usage is associated with lower A1c and decreased diabetes-related hospitalizations and emergency room visits. However, there are still many barriers to accessing CGM, with the most prominent being cost and cumbersome insurance eligibility criteria. We aimed to explore and describe barriers to enrollment in a pilot CGM program for Ohio Medicaid patients. Methods: Patients seen at a large academic medical center in the past year, a diabetes diagnosis and A1c >8.5% were identified by Medicaid. The pilot CGM program removed the need for the common CGM coverage requirements of prior authorizations, multiple daily injections, and glucose logs. Patients had to use a mobile CGM application to participate. Patients were contacted via phone and agreeable participants saw a diabetes care and education specialist for CGM education and initiation and an ambulatory care pharmacist for follow-up. Baseline characteristics were obtained via chart review and data were analyzed using descriptive analyses. Results: N=43 were contacted for enrollment (mean age 43.4±10.8 years; 88.4% female; 93.0% African American; mean A1c 10.2±2.0%; 58.1% on multiple daily injections) . In total, n=16 (37.2%) agreed to participate, n=17 (39.5%) were unable to be contacted, n=8 (18.6%) were already actively using CGM and n=2 (4.7%) declined to participate. Older age predicted agreeance to participate (β=0.350, p=.022) . Those who agreed to participate were more likely to see primary care over endocrinology for diabetes care X 2 (1, N=43) = .62, p=0.018. At one-month post-program enrollment, only n=2 (4.7%) patients successfully started CGM. Discussion: Although over one-third of participants agreed to enroll in the CGM pilot, there was low CGM initiation. Removal of cost and insurance coverage requirements alone did not result in high CGM adoption. Patients were difficult to reach via phone and offering CGM initiation and education during primary care appointments may improve CGM access and utilization. Disclosure W.Chen: None. J.E.Blanchette: Advisory Panel; Cardinal Health, Provention Bio, Inc., Board Member; JDRF, Consultant; WellDoc, Other Relationship; Insulet Corporation, Tandem Diabetes Care, Inc., Research Support; Association of Diabetes Care & Education Specialists. J.Macwilliams: None. B.Hatipoglu: None.

40-OR: 4T Study: Tighter Glucose Target Settings with Early CGM Initiation Further Improves A1C in Youth with T1D

In the Pilot 4T study (diagnosed July 2018 to May 2020, A1c target <7.5%, n=135) , early CGM initiation and remote patient monitoring (RPM) was associated with lower A1c. We hypothesized that tightening A1c targets to <7% would further lower A1c. All youth with newly diagnosed T1D from June 2020 to December 2021 were offered CGM initiation in the first month of diagnosis and RPM (4T cohort, n=115) . We compared A1c outcomes in the 4T cohort with the Pilot 4T cohort and the Historical cohort who were not offered early CGM (diagnosed 2014-2016, n=272) . We visualized population-based A1c trajectories using locally estimated scatter plot smoothing (LOESS, Fig) . Mean A1c at diagnosis was similar in the 4T and Pilot 4T cohorts (12.3% v 12.2%) and higher than the Historical cohort (10.7%) . The median age of diagnosis was 11.2 years [7.1, 14], 53% male, 35% non-Hispanic White, and 65% with private insurance in the 4T cohort. CGM initiation occurred within 30 days of diagnosis in 98.3% of youth. At 3, 6, and 9 months post-diagnosis, those in the 4T cohort had LOESS-based mean A1c differences of 0.33%, 0.36%, and 0.42% lower than the Pilot 4T cohort and 0.39%, 0.62%, and 0.96% lower than the Historical cohort. Early CGM initiation and RPM combined with tighter glucose targets was associated with a lower A1c compared to historical cohorts. These data support implementation of the 4T program with tight target setting in youth with T1D. Disclosure P.Prahalad: None. D.M.Maahs: Advisory Panel; Abbott Diabetes, Eli Lilly and Company, Medtronic, Novo Nordisk, Sanofi, Consultant; Aditx Therapeutics, Inc., Biospex. 4t study group: n/a. V.Ding: None. D.P.Zaharieva: Research Support; Insulet Corporation, International Society for Pediatric and Adolescent Diabetes, Leona M. and Harry B. Helmsley Charitable Trust. A.Addala: None. F.K.Bishop: None. D.Scheinker: None. R.Johari: None. M.Desai: None. K.K.Hood: Consultant; Cecelia Health, Havas Health, Insulet Corporation, LifeScan Diabetes Institute. Funding Stanford Diabetes Research Center (P30DK116074) and R18DK122422; Dexcom; Lucile Packard Children’s Hospital Auxiliaries Endowment

Psychological Characteristics and Goals of Caregivers Choosing Continuous Glucose Monitoring for Children With Type 1 Diabetes.

Continuous glucose monitoring (CGM) can improve glycemic outcomes in pediatric type 1 diabetes management. However, its impact on the psychosocial functioning of caregivers is less well described. The objectives of this pilot study were to explore caregiver reasons for adding CGM to their child's type 1 diabetes management, parental psychosocial function before initiating CGM, and the relationship between the two. Thirty-two families with a child with type 1 diabetes from Rainbow Babies and Children's Hospital diabetes clinics who were initiating CGM were recruited over 3 months. Before CGM initiation, the caregivers completed the Fear of Hypoglycemia Scale, State-Trait Anxiety Inventory, Problem Areas in Diabetes Scale, and a questionnaire assessing their primary reason for starting CGM. Participant characteristics and questionnaire results were summarized with descriptive statistics. Participants were grouped by reason for starting CGM, and results were compared among groups using ANOVA and reporting the global F test. Fifty percent of respondents indicated that they were starting CGM to optimize glycemic control. The majority of parents (71.8%) expressed worry about helplessness during a hypoglycemic episode. There were no statistically significant differences in patient characteristics or questionnaire results between groups. Forty-three percent of participating families started using CGM during the study's 8-month follow-up period. The main reason (64%) for not starting CGM was not having the chance to start the process of obtaining a CGM system. There were no statistically significant differences between children who did and did not start CGM. Caregivers have different reasons for starting CGM for their child with type 1 diabetes. Further studies are needed to understand whether these reasons are related to differences in psychosocial functioning. Despite interest in starting CGM, there remain barriers to implementation.

69-OR: Early CGM Initiation Improves A1C in Youth with T1D: Teamwork, Technology, Targets, and Tight Control (4T) Study

CGM use is associated with improvements in A1c. We hypothesized that initiation of CGM in the 1st month after T1D diagnosis would improve A1c. Youth with newly diagnosed T1D from July 2018 to May 2020 (pilot cohort, n=122) were offered CGM initiation in the 1st month after T1D diagnosis (119 started CGM). We compared A1c outcomes in the pilot cohort with those diagnosed from 2014-2016 (controls, n=272) who were not offered early CGM. We visualized A1c trajectories using locally estimated scatter plot smoothing (Fig). We and assessed for differences in A1c trajectory by cohort via interaction terms in a linear mixed model adjusted for baseline characteristics (age, sex, race and insurance type). The mean A1c at diagnosis was higher in the pilot cohort (12.2 vs. 10.7%). The median age of diagnosis was 9.5 years [6.8, 13.3], 64% male, 38% non-Hispanic White, and 76% with private insurance in the pilot cohort. In this pilot, 89% initiated CGM in the first 30 days after diagnosis compared to 2% in the control cohort. After adjusting for baseline characteristics, the mean A1c of the pilot cohort was lower at 6 months (-0.81, p = 0.019), 9 months (-1.43, p = 0.013), and 12 months (-2.05, p = 0.012) post-diagnosis compared to the historic cohort. Early initiation of CGM was associated with a lower A1c compared to those in a historic cohort. These data support early initiation of CGM as standard of care in youth with T1D. Disclosure P. Prahalad: None. J. Senaldi: None. A. Freeman: None. A. Addala: None. D. P. Zaharieva: None. K. K. Hood: Consultant; Self; Cecelia Health, Cercacor, LifeScan Diabetes Institute. D. Scheinker: Advisory Panel; Self; Carta Healthcare. M. Desai: None. D. M. Maahs: Advisory Panel; Self; Abbott Diabetes, Dompe, Eli Lilly and Company, Medtronic, Novo Nordisk, Consultant; Self; aditxt. V. Ding: None. B. Leverenz: None. J. Hooper: None. A. Chmielewski: None. B. P. Conrad: Advisory Panel; Self; Abbott Diabetes. J. Leverenz: None. A. Martinez-singh: None. P. Sagan: None. Funding National Institutes of Health (R18DK122422, P30DK116074)

916-P: Early CGM Initiation with Remote Monitoring Improves A1C in Youth with T1D

Previous studies have shown that CGM use and frequent contact with the care team is associated with improved A1c. We hypothesized that youth with new onset T1D started on CGM with weekly CGM data review by a CDE would have improved outcomes compared to those on CGM alone.Youth with newly diagnosed T1D from 7/2018 to 3/2019 were started on CGM alone (control, n=46) while those from 3/2019 to 5/2020 were started on CGM with weekly data review by a CDE (GluVue, n=76). Dose adjustments were made via secure messaging. We visualized A1c trajectories using locally estimated scatter plot smoothing (Fig) and assessed for differences in A1c trajectory by GluVue status via cohort*time and cohort*time2 interaction terms in a linear mixed model regression adjusted for baseline characteristics (age, sex, race and insurance type).The mean (SD) A1c at diagnosis was 12.0% (1.8) in the control group and 12.3% (2.3) in the GluVue group. Baseline characteristics of control vs. GluVue: male 25% vs. 39%, Non-Hispanic White 41.3% vs. 35.5%, private insurance 80.4% vs. 73.7%. Mean A1c of the GluVue cohort was lower at 6 months (-0.45%), 9 months (-0.07%), and 12 months (-0.52%) post-diagnosis. A1c trajectories were significantly different between groups via regression analysis (p=0.004).Early initiation of CGM with remote monitoring was associated with lower A1c compared to CGM alone. These data support early CGM initiation plus care team contact in youth with T1D.View largeDownload slideView largeDownload slide DisclosureP. Prahalad: None. K. K. Hood: Consultant; Self; Cecelia Health, Cercacor, LifeScan Diabetes Institute. D. Scheinker: Advisory Panel; Self; Carta Healthcare. M. Desai: None. D. M. Maahs: Advisory Panel; Self; Abbott Diabetes, Dompe, Eli Lilly and Company, Medtronic, Novo Nordisk, Consultant; Self; aditxt. V. Ding: None. B. Leverenz: None. J. Hooper: None. J. Leverenz: None. P. Sagan: None. A. Martinez-singh: None. A. Freeman: None. D. P. Zaharieva: None.FundingNational Institutes of Health (P30DK116074, R18DK122422)

Glycemic improvement with a novel interim intervention technique using retrospective professional continuous glucose monitoring (GLITTER study): A study from Mumbai, India

Background/aimsTo assess the efficacy of a novel interim intervention technique using retrospective, blinded, professional continuous glucose monitoring system (pro CGM) with the Freestyle Libre Pro system over a 14-day single sensor wear-period. MethodsA retrospective analysis comprised of 105 consecutive adults at single centre in India with Type 2 diabetes, HbA1c > 53 mmol/mol (>7%), on non-insulin divabetes agents and/or insulin. The interim intervention technique included three visits over 14 days: Visit 1, sensor placed and patients asked to keep a food log while on pro-CGM; Visit 2 (within 1 week), interim assessment of pro CGM and diet or pharmacotherapy modifications made accordingly; Visit 3 at day 14, pro CGM re-evaluated to assess glycemic control. Glucose target range was set at 70–180 mg/dL. Analyses included pre & post daily average glucose, time in range, time above range, and time below range. ResultsAverage time for interim analysis was 5 days after pro CGM initiation. At Visit 3, daily average glucose decreased from 191.3 mg/dL at baseline to 137.4 mg/dL (p < 0.001). Time in range improved from 42.2% to 80.2% (p < 0.001). Time above range decreased from 52.1% to 18.3% (p < 0.001), with a concurrent decrease in time below range from 5.7% to 1.5% (p < 0.001). Recurrent hypoglycemia was detected in 27 (25.7%) individuals, whose average baseline time below range reduced from 21.1% to 1.9% (p < 0.001). ConclusionThe interim intervention technique is a cost effective and efficient method for improving glucose outcomes through lifestyle and pharmacotherapy modifications and while utilizing a single pro-CGM sensor. Location of StudyWockhardt Hospital, Mumbai, India. Clinical Registrationnot applicable due to retrospective chart review study design.

Timing of CGM initiation in pediatric diabetes: The CGM TIME Trial.

ObjectiveTo determine whether timing of CGM initiation offering low glucose suspend (LGS) affects CGM adherence in children and youth starting insulin pump therapy.MethodsA 5‐site RCT of pump‐naïve subjects (aged 5‐18 years) with type 1 diabetes (T1D) for at least 1 year compared simultaneous pump and CGM initiation offering LGS vs standard pump therapy with CGM initiation delayed for 6 months. Primary outcome was CGM adherence (hours per 28 days) (MiniMed™ Paradigm™ Veo™ system; CareLink Pro™ software) over 6 months after CGM initiation. Secondary outcome HbA1c was measured centrally. Linear mixed‐models and ordinary least squares models were fitted to estimate effect of intervention, and covariates baseline age, T1D duration, HbA1c, gender, ethnicity, hypoglycemia history, clinical site, and association between CGM adherence and HbA1c.ResultsThe trial randomized 144/152 (95%) eligible subjects. Baseline mean age was 11.5 ± 3.3(SD) years, T1D duration 3.4 ± 3.1 years, and HbA1c 7.9 ± 0.9%. Six months after CGM initiation, adjusted mean difference in CGM adherence was 62.4 hours per 28 days greater in the Simultaneous Group compared to Delayed Group (P = .007). There was no difference in mean HbA1c at 6 months. However, for each 100 hours of CGM use per 28‐day period, HbA1c was 0.39% (95% CI 0.10%‐0.69%) lower. Higher CGM adherence was associated with reduced time with glucose >10 mmol/L (P < .001).ConclusionCGM adherence was higher after 6 months when initiated at same time as pump therapy compared to starting CGM 6 months after pump therapy. Greater CGM adherence was associated with improved HbA1c.

Type 1 diabetes outcomes of children born in Israel of Eritrean asylum seekers.

Disparities in health outcomes in pediatric type 1 diabetes (T1D) based on race/ethnicity and socioeconomic position (SEP) have been reported. We compared T1D characteristics between Eritrean status-less children living in Israel and native-born Israeli children. This observational study compared 7 Eritrean and 28 Israeli children (< 8years old at T1D diagnosis) who were diagnosed in a single diabetes center during 2015-2019. Sociodemographic and diabetes-related data from diagnosis until the last clinic visit were retrieved from their medical files. At diagnosis, the mean age was 4.8 ± 2.2years, 17 (48.6%) had diabetic ketoacidosis with a mean HbA1c level of 10.5 ± 2.1% (91.3mmol/mol) and 29 (82.9%) had ≥ 2 pancreatic autoantibodies. The mean T1D duration of follow-up was 2.7 ± 1.4years. Overall glycemic control during follow-up (> 6months from diagnosis, mean number of samples 10.6 ± 5.2) was good, with mean, best, and peak HbA1c levels of 7.4 ± 0.8% (57.4mmol/mol), 6.7 ± 0.7% (49.7mmol/mol), and 8.1 ± 1.1% (65mmol/mol), respectively. Thirty-two children (91.4%) used continuous glucose monitoring devices (CGMs), and the mean time from diagnosis to CGM initiation was 10.8 ± 14.1months. CGM metrics: time CGM active: 95.4 ± 3.8%, mean glucose level: 170.0 ± 27.0mg/dl (9.4mmol/L), time-in-range: 56.4 ± 14.7%, time-below-range: 5.5 ± 5.7%, and time-above-range: 38.6 ± 16.1%. Diabetes-related parameters at diagnosis and during follow-up were similar between groups. Eritrean children had significantly lower SEPs (P < 0.001) and parental education levels (P < 0.001). Correlations between SEP and diabetes parameters and SEP and growth parameters were not significant. Eritrean status-less children in Israel achieved glycemic targets similar to those of Israeli children, perhaps reflecting uniformity in the standard of care and CGM usage.

1297-P: Early CGM Initiation Improves HbA1c in T1D Youth over the First 15 Months

CGM use is associated with lower HbA1c in people with T1D. We hypothesize early CGM initiation will improve longer term HbA1c. Youth with newly diagnosed T1D from July 2018 to May 2019 (pilot cohort, n=65), were offered CGM initiation in the 1st month of T1D diagnosis with 62 initiating CGM. We compared HbA1c outcomes in this pilot cohort with those diagnosed in 2014-2016 (control cohort, n=272) with follow-up duration restricted to 15 months. HbA1c trajectories were visualized using locally estimated scatter plot smoothing (Figure 1) and compared using a generalized mixed effects regression model adjusted for baseline characteristics (HbA1c at onset, age, sex, race and insurance type). Mean HbA1c at diagnosis was higher in the pilot cohort (12.0% vs. 10.7%). Over the first 15 months of T1D, CGM was initiated in 95% of the pilot cohort (78.5% within 30 days), whereas 56% initiated in the control cohort (1.8% within 30 days). Adjusting for baseline characteristics, mean HbA1c levels were 0.5% lower (95%CI: -1.0, -0.1) in the pilot cohort at 3 months and 1.7% lower (95% CI: -2.6, -0.8) at 6 months compared to the control cohort. Differences beyond 6 months were also in the expected direction and statistically significant at the 0.05 level. Early initiation of CGM in the new onset period was associated with lower HbA1c compared to historic controls. These data suggest that early CGM initiation should be considered a part of standard new onset T1D care. Disclosure P. Prahalad: None. V. Ding: None. A. Addala: None. C. New: None. B.P. Conrad: None. A. Chmielewski: None. E. Geels: None. J. Leverenz: None. A. Martinez-Singh: None. P. Sagan: None. J. Senaldi: None. A. Freeman: None. D. Scheinker: None. K.K. Hood: Research Support; Self; Dexcom, Inc. Speaker’s Bureau; Self; LifeScan, Inc., MedIQ. M. Desai: None. D.M. Maahs: Advisory Panel; Self; Eli Lilly and Company, Insulet Corporation, Medtronic, Novo Nordisk A/S. Consultant; Self; Abbott, Sanofi. Research Support; Self; Bigfoot Biomedical, Dexcom, Inc., Roche Diabetes Care, Tandem Diabetes Care.

MON-097 Continuous Glucose Monitoring in Youth with Type 1 Diabetes; Parental Anxiety and Parent Defined Outcomes: Results of Follow up Surveys

Continuous glucose monitors (CGMs) can be helpful in management of type 1 diabetes (T1D). Our objectives were to explore parental reason for adding CGM to their child’s T1D management and to describe potential barriers to starting CGM. Prior to CGM initiation, the primary caregiver of a child with T1D completed validated questionnaires including Fear of Hypoglycemia Scale (FOH), State-Trait Anxiety Inventory (STAI), Problem Areas in Diabetes Scale (PAID), and an investigator developed questionnaire assessing primary reason for starting CGM. Surveys were repeated 3-8 months after adding CGM.The results of the initial surveys reported elsewhere suggest that the most common reason for starting CGM is to improve glycemic control. Out of 32 participants who completed initial surveys and intended to start CGM on their child, only 43% (N=14) started using CGM during the 3-8 month follow up period. Reasons for not starting CGM included: not having the chance to start the process of having it approved by insurance in 64% (N=9), and difficulties getting insurance to approve CGM in 28% (N=4). One participant reported that despite insurance coverage, out of pocket expense was too much.Wilcoxon Rank Sum tests were used to compare demographic variables between those that started and those that did not start CGM. Medians were used to report the results. There were no statistically significant differences between children who did and did not start CGM in terms of age (9.3 vs. 11.4 yrs, P=0.3), baseline HbA1c (8.1% vs. 9.4%, P=0.1), and diabetes duration (3.0 vs. 4.3 yrs, P=0.6).In summary, despite parental interest in CGM initiation for their children with type 1 diabetes, there remains a significant barrier to implementation from delays in getting insurance approval. Revision of policies related to CGM coverage in youth need to be revised and systems in place to expedite approval.

1358-P: Early CGM Initiation in New-Onset Type 1 Diabetes Patients

A minority of children and adolescents with T1D meet HbA1c targets as recommended in the ADA guidelines. We have previously shown that in our clinic there is a sharp inflection point in HbA1c trajectory starting between 5 and 6 months of diagnosis with a rise in HbA1c from 7.0 ± 1.5% at 5 months post-diagnosis to 8.0 ± 1.7% at 12 months post-diagnosis. Given the benefits of CGM and improved CGM technology, we started a clinical program to initiate CGM therapy within the first month of diabetes diagnosis aimed at decreasing the rise in HbA1c that occurs over the first year of diagnosis. Since initiating this program in August 2018, 20 youth with T1D were started on the Dexcom G6 CGM system within the first month of diagnosis (average time to start is 8.5 ± 1.3 days post-diagnosis, 3 declined CGM initiation). The average age at T1D onset was 10.1 ± 0.8 years and 50% presented in DKA. Mean HbA1c at diagnosis was 12.0 ± 4.0%. In this cohort, 45% were male, 50% non-Hispanic white, 85% had private insurance, and 85% spoke English as the primary language. A majority of clinic patients used the mobile phone as their CGM receiver (73%) and all of these individuals used the Share feature. A majority of clinic patients (75%) have had at least 2 follow-up visits. By the second follow-up visit (46.1 ± 3.9 days since CGM start), patients were wearing the CGM on average of 94.5 ± 5.9% of the days over the last 2 weeks. Of the 20 individuals initially started on CGM, 3 were no longer using it at the time of their most recent visit. Two of the individuals had issues with insurance coverage and the third had issues with the transmitter. The incidence of hypoglycemia was low (2.2 ± 0.7%) and the patients had a time in range (TIR, glucose 70 - 180 mg/dL) of 71.1 ± 4.6%. In our cohort, patients continued to use CGM with a high percent of wear time. Although we do not have a control or comparison group, our population had a low incidence of hypoglycemia and high percentage of TIR. These data suggest that CGM can be successfully started within 2 weeks of T1D diagnosis with potential benefits on glucose control. Disclosure P. Prahalad: None. D. Scheinker: Advisory Panel; Self; Carta Healthcare. K.K. Hood: Consultant; Self; Lilly Diabetes. Research Support; Self; Dexcom, Inc. Speaker's Bureau; Self; Johnson &amp; Johnson Diabetes Institute. B.A. Buckingham: Advisory Panel; Self; ConvaTec Inc., Novo Nordisk Inc., Profusa, Inc. Consultant; Self; Medtronic MiniMed, Inc. Research Support; Self; Beta Bionics, ConvaTec Inc., Dexcom, Inc., Insulet Corporation, Medtronic MiniMed, Inc., Tandem Diabetes Care. Other Relationship; Self; Insulet Corporation, Tandem Diabetes Care. D.M. Wilson: Advisory Panel; Self; Tolerion, Inc. Research Support; Self; Beta Bionics, Dexcom, Inc., Medtronic. A. Chmielewski: None. B.P. Conrad: None. E. Geels: None. J. Leverenz: None. K. Peterson: None. D.M. Maahs: Advisory Panel; Self; Novo Nordisk Inc. Consultant; Self; Abbott, Sanofi. Research Support; Self; Dexcom, Inc., Tandem Diabetes Care.

Motivational Stage at CGM Initiation Is Less Important than Timing of CGM Initiation in Predicting CGM Adherence

Background: Readiness for making behavioral changes is a key factor determining success in the adoption of technologies like CGM in type 1 diabetes (T1D). SOCRATES (Stages of Change Readiness and Treatment Eagerness Scale-Diabetes Version) can classify individuals into 1 of 5 motivational stages: Precontemplation, Contemplation, Determination, Action and Maintenance. It was used in the CGM TIME Trial, a multicenter pediatric RCT comparing simultaneous pump and CGM (“SIM” group) to initiation of CGM 6 months later (“DEL” group) (MiniMed Veo™ System). Aim: To examine the association of SOCRATES scores with 1) A1C at trial entry and 2) CGM adherence and change in A1C 6 months after CGM initiation. Methods: 97/99 eligible children aged 10-18 years and 136/141 eligible parents completed SOCRATES at trial entry and 6 months. Multivariable linear regression tested the association between motivational stage and 1) child’s A1C at trial entry, and 2) change in A1C and CGM adherence 6 months after CGM initiation, adjusted for randomization group, gender, age, and diabetes duration. Results: At trial entry, mean adjusted A1C was 1.02% lower for children in Precontemplation than those in Action (p&amp;lt;0.0001). The A1C of children whose parents were in Precontemplation was 0.83% lower than those in Maintenance (p=0.02) and 0.35% lower than those in Action (p=0.048). Motivational stage of children and parents at CGM initiation was not associated with CGM adherence or change in A1C 6 months later whereas there was an intervention effect with the SIM group using CGM an additional 3.4 hours per day (p=0.03) compared to the DEL group. Conclusions: SOCRATES scores were associated with A1C at trial entry, but did not predict future CGM adherence or change in A1C. SOCRATES was a poor measure of readiness for change in children with T1D and their parents who were participating in a clinical trial. CGM adherence was related more to timing of CGM initiation than motivational stage. Disclosure K. Verbeeten: None. J. Chan: None. N. Sourial: None. M.L. Lawson: None.

Timing of CGM Initiation in Pediatric Diabetes—The CGM TIME Trial

Background: The impact of timing of CGM initiation in pump naïve pediatric patients on CGM adherence and hemoglobin A1C remains unclear. Methods: A 5-site RCT of pump naïve subjects (aged 5-18 years) with type 1 diabetes (T1D) &amp;gt; 1 year was conducted to compare simultaneous pump and CGM (“SIM” group) vs. standard pump therapy with CGM initiation delayed for 6 months (“DEL” group). A step-wise approach to CGM settings was used. Primary outcome was CGM adherence (hours per 28 days (MiniMed™ Veo™ system and CareLink Professional use)) assessed over six months after CGM initiation. The main secondary outcome, A1Cs, was measured centrally at baseline and every 6 months. Linear mixed-models and ordinary least squares models were fitted to further estimate the effect of intervention, and covariates of baseline age, T1D duration, and A1C, as well as gender and clinical site. Results: We randomized 144 of 152 (95%) eligible subjects into the SIM or DEL intervention. Five (3 SIM, 2 DEL) withdrew before visit 1 and 1 (DEL) a week after pump start, with 70 SIM, 68 DEL eligible for analysis. Baseline mean age was 11.5±3.3(SD) years, T1D duration 3.4±3.1 years, and A1C 7.9±0.9% (range 5.5-11.2%). During the 6th month, median CGM adherence was 485.6 hours (95% CI: 229.5, 585.7) in SIM vs. 408.2 (95% CI: 134.9, 572.8) in DEL, with this difference in adherence translating into an additional 2.8 hours of CGM per day. Median 6-month A1C was 7.9 [IQR: 7.5, 8.4] for SIM vs. 7.8 [IQR: 7.4, 8.4] for DEL. Fitted models suggest those randomized to SIM had better CGM adherence (main effect = 74.4 [95% CI: 26.8, 121.9], p=0.002), with higher adherence among females (p=0.03). Overall, there was no difference in A1C 6 months after CGM initiation (-0.20 [95% CI: -0.45, 0.06], p=0.13). Conclusion: CGM adherence was higher when initiated at the same time as pump therapy however there was no significant effect on A1C. More research is required to understand why CGM did not have an effect on A1C and examine how CGM may affect other measures of glycemic control. Disclosure M.L. Lawson: None. J. Courtney: None. B.J. Bradley: None. K. McAssey: None. C. Clarson: None. S.E. Kirsch: None. J. Curtis: None. F.H. Mahmud: None. C. Richardson: Advisory Panel; Self; Dexcom, Inc.. T. Cooper: None. K. Tang: None.