Blinded Continuous Glucose Monitoring Research Articles

The northeast glucose drift: Stratification of post-breakfast dysglycemia among predominantly Hispanic/Latino adults at-risk or with type 2 diabetes.

SummaryBackgroundThere is minimal experience in continuous glucose monitoring (CGM) among underserved racial/ethnic minority populations with or at risk of type 2 diabetes (T2D), and therefore a lack of CGM-driven insight for these individuals. We analyzed breakfast-related CGM profiles of free-living, predominantly Hispanic/Latino individuals at-risk of T2D, with pre-T2D, or with non-insulin treated T2D.MethodsStarting February 2019, 119 participants in Santa Barbara, CA, USA, (93 female, 87% Hispanic/Latino [predominantly Mexican-American], age 54·4 [±12·1] years), stratified by HbA1c levels into (i) at-risk of T2D, (ii) with pre-T2D, and (iii) with non-insulin treated T2D, wore blinded CGMs for two weeks. We compared valid CGM profiles from 106 of these participants representing glucose response to breakfast using four parameters.FindingsA “northeast drift” was observed in breakfast glucose responses comparing at-risk to pre-T2D to T2D participants. T2D participants had a significantly higher pre-breakfast glucose level, glucose rise, glucose incremental area under the curve (all p < 0·0001), and time to glucose peak (p < 0·05) compared to pre-T2D and at-risk participants. After adjusting for demographic and clinical covariates, pre-breakfast glucose and time to peak (p < 0·0001) were significantly associated with HbA1c. The model predicted HbA1c within (0·550·67)% of true laboratory HbA1c values.InterpretationFor predominantly Hispanic/Latino adults, the average two-week breakfast glucose response shows a progression of dysglycemia from at-risk of T2D to pre-T2D to T2D. CGM-based breakfast metrics have the potential to predict HbA1c levels and monitor diabetes progression.FundingUS Department of Agriculture (Grant #2018–33800–28404), a seed grant from the industry board fees of the NSF Engineering Research Center for Precise Advanced Technologies and Health Systems for Underserved Populations (PATHS-UP) (Award #1648451), and the Elsevier foundation.

Continuous glucose monitoring systems for monitoring cystic fibrosis-related diabetes.

Cystic fibrosis(CF) is one of the most common life-shortening autosomal-recessive genetic conditions with around 100,000 people affected globally. CF mainly affects the respiratory system, but cystic fibrosis-related diabetes(CFRD) is a common extrapulmonary co-morbidity and causes excess morbidity and mortality in this population. Continuous glucose monitoring systems(CGMS) are a relatively new technology and, as yet, the impact of these on the monitoring and subsequent management of CFRD remains undetermined. To establish the impact of insulin therapy guided by continuous glucose monitoring compared to insulin therapy guided by other forms of glucose data collection on the lives of people with CFRD. We searched the Cochrane Cystic Fibrosis Trials Register, compiled from electronic database searches and handsearching of journals and conference abstract books. Date of latest search: 23 September 2021. We also searched the reference lists of relevant articles and reviews and online trials registries.Date of last search: 23 September 2021. Randomised controlled studies comparing insulin regimens led bydata from CGMS (including real-time or retrospective data, orboth) with insulin regimens guided by abnormal blood glucose measurements collected through other means of glycaemic data collection in people with CFRD. Studies with a cross-over design, even with a washout period between intervention arms, are not eligible for inclusion due to the potential long-term impact of each of the interventions and the potential to compromise the outcomes of the second intervention. No studies were included in the review, meaning that no data were available to be collected for analysis. Review authors screened 14 studies at the full-text stage against the review'sinclusion criteria. Consequently, seven were excluded due to the study type being ineligible (not randomised), two studies were excluded due to their cross-over design, and two studies was excluded since theintervention used was not eligible and one was a literature review. One study in participants hospitalised for a pulmonary exacerbation is ongoing. Investigators are comparing insulin dosing via insulin pump with blood sugar monitoring by a CGMS to conventional diabetes management with daily insulin injections (or on an insulin pump if already on an insulin pump in the outpatient setting) and capillary blood glucose monitoring. The participants in the control arm will wear a blinded continuous glucose monitoring system for outcome assessment. In addition to this, one further study is still awaiting classification, and will be screened to determine whether it is eligible for inclusion, or is to be excluded, in an update of this review. No studies were included in the review, indicating that there is currently insufficient evidence to determine the impact of insulin therapy guided by CGMS compared to insulin therapy guided by other forms of glucose data collection on the lives of people with CFRD, nor on potential adverse effects of continuous glucose monitoring in this context. Randomised controlled studies are needed to generate evidence on the efficacy and safety of continuous glucose monitoring in people with CFRD. There is one relevant ongoing study that may be eligible for inclusion in a future update of this Cochrane Review, and whose results may help answer the review question.

Function and Emotion in Everyday Life With Type 1 Diabetes (FEEL-T1D): Protocol for a Fully Remote Intensive Longitudinal Study.

BackgroundAlthough short-term blood glucose levels and variability are thought to underlie diminished function and emotional well-being in people with type 1 diabetes (T1D), these relationships are poorly understood. The Function and Emotion in Everyday Life with T1D (FEEL-T1D) study focuses on investigating these short-term dynamic relationships among blood glucose levels, functional ability, and emotional well-being in adults with T1D.ObjectiveThe aim of this study is to present the FEEL-T1D study design, methods, and study progress to date, including adaptations necessitated by the COVID-19 pandemic to implement the study fully remotely.MethodsThe FEEL-T1D study will recruit 200 adults with T1D in the age range of 18-75 years. Data collection includes a comprehensive survey battery, along with 14 days of intensive longitudinal data using blinded continuous glucose monitoring, ecological momentary assessments, ambulatory cognitive tasks, and accelerometers. All study procedures are conducted remotely by mailing the study equipment and by using videoconferencing for study visits.ResultsThe study received institutional review board approval in January 2019 and was funded in April 2019. Data collection began in June 2020 and is projected to end in December 2021. As of June 2021, after 12 months of recruitment, 124 participants have enrolled in the FEEL-T1D study. Approximately 87.6% (7082/8087) of ecological momentary assessment surveys have been completed with minimal missing data, and 82.0% (82/100) of the participants provided concurrent continuous glucose monitoring data, ecological momentary assessment data, and accelerometer data for at least 10 of the 14 days of data collection.ConclusionsThus far, our reconfiguration of the FEEL-T1D protocol to be implemented remotely during the COVID-19 pandemic has been a success. The FEEL-T1D study will elucidate the dynamic relationships among blood glucose levels, emotional well-being, cognitive function, and participation in daily activities. In doing so, it will pave the way for innovative just-in-time interventions and produce actionable insights to facilitate tailoring of diabetes treatments to optimize the function and well-being of individuals with T1D.International Registered Report Identifier (IRRID)DERR1-10.2196/30901

Time-Limited Eating and Continuous Glucose Monitoring in Adolescents with Obesity: A Pilot Study.

Due to its simplicity, time-limited eating (TLE) may represent a more feasible approach for treating adolescents with obesity compared to other caloric restriction regimens. This pilot study examines the feasibility and safety of TLE combined with continuous glucose monitoring (CGM) in adolescents. Fifty adolescents with BMI ≥95th percentile were recruited to complete a 12-week study. All received standard nutritional counseling, wore a CGM daily, and were randomized to: (1) Prolonged eating window: 12 h eating/12 h fasting + blinded CGM; (2) TLE (8 h eating/16 h fasting, 5 days per week) + blinded CGM; (3) TLE + real-time CGM feedback. Recruitment, retention, and adherence were recorded as indicators of feasibility. Weight loss, dietary intake, physical activity, eating behaviors, and quality of life over the course of the intervention were explored as secondary outcomes. Forty-five participants completed the study (16.4 ± 1.3 years, 64% female, 49% Hispanic, 75% public insurance). There was high adherence to prescribed eating windows (TLE 5.2 d/wk [SD 1.1]; control 6.1 d/wk [SD 1.4]) and daily CGM wear (5.85 d/wk [SD 4.8]). Most of the adolescents (90%) assigned to TLE reported that limiting their eating window and wearing a CGM was feasible without negative impact on daily functioning or adverse events. There were no between-group difference in terms of weight loss, energy intake, quality of life, physical activity, or eating behaviors. TLE combined with CGM appears feasible and safe among adolescents with obesity. Further investigation in larger samples, with a longer intervention duration and follow-up assessments are needed.

The Effect of DPP4 Inhibitor on Glycemic Variability in Patients with Type 2 Diabetes treated with twice-daily Premixed Human Insulin

ObjectiveTo evaluate the effect of adding DPP4 inhibitor (DPP4-i) on glycemic variability (GV) in patients with type 2 diabetes mellitus (T2DM) treated with premixed human insulin (MHI).MethodologyWe conducted a prospective study in patients with T2DM on twice-daily MHI with or without metformin therapy. Blinded continuous glucose monitoring was performed at baseline and following 6 weeks of Vildagliptin therapy.ResultsTwelve patients with mean (SD) age of 55.8 (13.1) years and duration of disease of 14.0 (6.6) years were recruited. The addition of Vildagliptin significantly reduced GV indices (mmol/L): SD from 2.73 (IQR 2.12-3.66) to 2.11 (1.76-2.55), p=0.015; mean amplitude of glycemic excursions (MAGE) 6.94(2.61) to 5.72 (1.87), p=0.018 and CV 34.05 (8.76) to 28.19 (5.36), p=0.010. In addition, % time in range (3.9-10 mmol/l) improved from 61.17 (20.50) to 79.67 (15.33)%, p=0.001; % time above range reduced from 32.92 (23.99) to 18.50 (15.62)%, p=0.016; with reduction in AUC for hyperglycemia from 1.24 (1.31) to 0.47 (0.71) mmol/day, p=0.015. Hypoglycemic events were infrequent and the reduction in time below range and AUC for hypoglycemia did not reach statistical significance.ConclusionThe addition of DPP4-I to commonly prescribed twice-daily MHI in patients with T2DM improves GV and warrants further exploration.

Use of factory-calibrated real-time continuous glucose monitoring improves time in target and HbA1c in a multiethnic cohort of adolescents and young adults with type 1 diabetes: the MILLENNIALS study

OBJECTIVE International type 1 diabetes registries have shown that HbA1c levels are highest in young people with type 1 diabetes; however, improving their glycemic control remains a challenge. We propose that use of the factory-calibrated Dexcom G6 CGM system would improve glycemic control in this cohort. RESEARCH DESIGN AND METHODS We conducted a randomized crossover trial in young people with type 1 diabetes (16–24 years old) comparing the Dexcom G6 CGM system and self-monitoring of blood glucose (SMBG). Participants were assigned to the interventions in random order during two 8-week study periods. During SMBG, blinded continuous glucose monitoring (CGM) was worn by each participant for 10 days at the start, week 4, and week 7 of the control period. HbA1c measurements were drawn after enrollment and before and after each treatment period. The primary outcome was time in range 70–180 mg/dL. RESULTS Time in range was significantly higher during CGM compared with control (35.7 ± 13.5% vs. 24.6 ± 9.3%; mean difference 11.1% [95% CI 7.0–15.2]; P CONCLUSIONS CGM use in young people with type 1 diabetes improves time in target and HbA1c levels compared with SMBG.

Flash glucose monitoring and automated bolus calculation in type 1 diabetes treated with multiple daily insulin injections: a 26week randomised, controlled, multicentre trial.

We aimed to compare the effects of intermittently scanned continuous glucose monitoring (isCGM) and carbohydrate counting with automated bolus calculation (ABC) with usual care. In a randomised, controlled, open-label trial carried out at five diabetes clinics in the Capital Region of Denmark, 170 adults with type 1 diabetes for ≥1year, multiple daily insulin injections and HbA1c > 53mmol/mol (7.0%) were randomly assigned 1:1:1:1 with centrally prepared envelopes to usual care (n = 42), ABC (n = 41), isCGM (n = 48) or ABC+isCGM (n = 39). Blinded continuous glucose monitoring data, HbA1c and patient-reported outcomes were recorded at baseline and after 26weeks. The primary outcome was change in time in range using isCGM vs usual care. Baseline characteristics were comparable across arms: mean age 47 (SD 13.7) years, median (IQR) diabetes duration 18 (10-28) years and HbA1c 65 (61-72) mmol/mol (8.1% [7.7-8.7%]). Change in time in range using isCGM was comparable to usual care (% difference of 3.9 [-12-23], p = 0.660). The same was true for the ABC and ABC+isCGM arms and for hypo- and hyperglycaemia. Also compared with usual care, using ABC+isCGM reduced HbA1c (4 [95% CI 1, 8] mmol/mol) (0.4 [0.1, 0.7] %-point) and glucose CV (11% [4%, 17%]) and improved treatment satisfaction, psychosocial self-efficacy and present life quality. Treatment satisfaction also improved by using isCGM alone vs usual care. Statistical significance was maintained after multiple testing adjustment concerning glucose CV and treatment satisfaction with ABC+isCGM, and treatment satisfaction with isCGM. Discontinuation was most common among ABC only users, and among completers the ABC was used 4 (2-5) times/day and the number of daily isCGM scans was 5 (1-7) at study end. isCGM alone did not improve time in range, but treatment satisfaction increased in technology-naive people with type 1 diabetes and suboptimal HbA1c. The combination of ABC+isCGM appears advantageous regarding glycaemic variables and patient-reported outcomes, but many showed resistance towards ABC. ClinicalTrials.gov NCT03682237. The study is investigator initiated and financed by the Capital Region of Denmark.

Effect of insulin degludec versus insulin glargine U100 on time in range: SWITCH PRO, a crossover study of basal insulin-treated adults with type 2 diabetes and risk factors for hypoglycaemia.

AimsTo compare time in range (TIR) with use of insulin degludec U100 (degludec) versus insulin glargine U100 (glargine U100) in people with type 2 diabetes.Materials and MethodsWe conducted a randomized, crossover, multicentre trial comparing degludec and glargine U100 in basal insulin‐treated adults with type 2 diabetes and ≥1 hypoglycaemia risk factor. There were two treatment periods, each with 16‐week titration and 2‐week maintenance phases (with evaluation of glucose using blinded professional continuous glucose monitoring). The once‐weekly titration (target: 3.9–5.0 mmol/L) was based on pre‐breakfast self‐measured blood glucose. The primary endpoint was percentage of TIR (3.9─10.0 mmol/L). Secondary endpoints included overall and nocturnal percentage of time in tight glycaemic range (3.9–7.8 mmol/L), and mean glycated haemoglobin (HbA1c) and glucose levels.ResultsAt baseline, participants (n = 498) had a mean (SD) age of 62.8 (9.8) years, a diabetes duration of 15.1 (7.7) years and an HbA1c level of 59.6 (11.0) mmol/mol (7.6 [1.0]%). Noninferiority and superiority were confirmed for degludec versus glargine U100 for the primary endpoint, with a mean TIR of 72.1% for degludec versus 70.7% for glargine U100 (estimated treatment difference [ETD] 1.43% [95% confidence interval (CI): 0.12, 2.74; P = 0.03] or 20.6 min/d). Overall time in tight glycaemic range favoured degludec versus glargine U100 (ETD 1.5% [95% CI: 0.15, 2.89] or 21.9 min/d). Degludec also reduced nocturnal time below range (TBR; <3.9 mmol/L) compared with glargine U100 (ETD −0.88% [95% CI: −1.34, −0.42] or 12.7 min/night; post hoc) and significantly fewer nocturnal hypoglycaemic episodes of <3.0 mmol/L were observed.ConclusionsDegludec, compared with glargine U100, provided more TIR and time in tight glycaemic range, and reduced nocturnal TBR in insulin‐treated people with type 2 diabetes.

75-LB: Can Continuous Glucose Monitoring Be Utilized to Monitor Adherence to Time-Limited Eating in Adolescents with Obesity?

Background: One limitation to studying time limited eating (TLE) in adolescents is difficulty in reliably assessing adherence to fasting periods. Dietary recalls, which are currently used to monitor diet adherence, have been criticized due to potential error in reporting, omission bias and suboptimal compliance. Continuous glucose monitoring (CGM) may be a useful tool to overcome these barriers; however, it requires daily wear and understanding of expected glycemic excursions. The present study examines the feasibility of daily CGM use and its utility as a tool to monitor adherence to fasting periods in a diverse cohort of adolescents with obesity participating in a pilot study of 8-hour TLE. Methods: Twenty adolescents (mean age 16.0+1.3 years, 70% female, 55% Latinx, 75% public insurance) with BMI ≥ 95th percentile, were enrolled in a 12-week study and randomized to: (1) Group 1 (control schedule): 12-hour eating period + blinded CGM, (2) Group 2 (TLE schedule): 8-hour eating period + blinded CGM, or (3) Group 3: 8-hour eating period + CGM with real-time feedback. CGM wear time was calculated as the actual weekly wear time divided by the prescribed wear time. At weeks 0, 4 and 12, CGM data from 7 days of self-reported fasting periods were reviewed to evaluate any glycemic excursions &amp;gt;50 ng/dL. Results: Overall, the mean CGM wear time was 90% (35-100%) with no difference between intervention arms. During self-reported fasting periods, only 4 adolescents had excursions &amp;gt;50 ng/dL, one of whom was diagnosed with type 2 diabetes. The remaining 16 participants had no excursions &amp;gt;50 ng/dL during their fasting periods. Conclusions: These data suggest that CGM may be a feasible tool to monitor adherence to TLE and provide a more accurate assessment of true fasting periods with less opportunity for error and bias when compared to self-report. Larger studies are needed to validate these findings and further explore the use of CGM as a tool in obesity research in adolescents. Disclosure M. Naguib: None. M. I. Goran: None. J. Raymond: None. E. Hegedus: None. C. Wee: None. A. Vidmar: None.

2-LB: Flash Glucose Monitoring in the Reduction of Hypoglycemia in Diabetic Kidney Disease: A Randomised Controlled Trial

Patients with moderate-to-advanced diabetic kidney disease (DKD) are at high risk of hypoglycemia. There are few studies evaluating personal continuous glucose monitoring (CGM) use in this group. We investigated whether flash glucose monitoring (FGM) was effective in reducing hypoglycemia compared with standard self-monitoring of blood glucose (SMBG) in individuals with chronic kidney disease (CKD) stages 3b-5 (non-dialysis). This was a single-centre, parallel-group randomised clinical trial of 94 adults with diabetes and CKD [G3b (n=36), G4 (n=44) and G5 (n=14)] and a history of hypoglycemia. Patients were randomly assigned 1:1 to FGM or SMBG for 16 weeks. Both groups received structured education on hypoglycemia and monthly reviews by healthcare professionals. Blinded CGM was performed at baseline and end of study in both groups. Patients were aged (mean±SD) 65.4±9.0 years with estimated glomerular filtration rate (eGFR) 26.1±9.6 ml/min/1.73m2, HbA1c 7.4±0.8% and median duration of diabetes for 20 years. 93 patients had type 2 diabetes and 99% were on insulin. After 16 weeks, percentage time &amp;lt;70mg/dL (3.9 mmol/L) decreased significantly from 4.0% to 2.5% in FGM group (- 1.7%; 95% CI -3.4 to -0.01%) but not in SMBG group (-1.1%; 95% CI -2.6 to 0.4%; between-group difference, p=0.73). Mean HbA1c improved significantly in both FGM (-0.33%, 95% CI -0.52 to -0.1) and SMBG groups (-0.36%, 95% CI -0.52 to -0.21; between-group difference p=0.08). One severe hypoglycemic event occurred in the FGM and none in SMBG group. The acceptability of FGM was high with overall 87% mean sensor use and average 8 scans per day. FGM was effective in reducing hypoglycemia and improving HbA1c in moderate-to-advanced DKD, but not significantly different from SMBG. Future studies are needed to assess whether real-time CGM with alerts would further reduce hypoglycemic episodes in this high-risk group. Disclosure J. Ling: None. J. K. Ng: None. R. C. Ma: Other Relationship; Self; AstraZeneca, Medtronic, Research Support; Self; AstraZeneca, Bayer Healthcare Pharmaceuticals Inc., Novo Nordisk, Pfizer Inc., Sanofi-Aventis, Tricida, Inc. A. P. Kong: Advisory Panel; Self; Lilly Diabetes, Speaker’s Bureau; Self; Abbott, AstraZeneca, Bayer Healthcare Pharmaceuticals Inc., Lilly Diabetes, Sanofi, Stock/Shareholder; Self; Aptorum. A. Luk: None. C. Szeto: None. J. C. Chan: Consultant; Self; Bayer AG, Boehringer Ingelheim International GmbH, MSD Corporation, Sanofi, Other Relationship; Self; Asia Diabetes Foundation, GemVCare, Research Support; Self; Applied Therapeutics, AstraZeneca, Hua Medicine, Lilly Diabetes, Merck KGaA. E. Chow: Research Support; Self; Medtronic, Speaker’s Bureau; Self; Novartis Pharmaceuticals Corporation, Sanofi-Aventis. Funding Hong Kong College of Physicians; University Grants Committee Research Matching Grant Scheme

613-P: Performance Evaluation of Dexcom G6 Continuous Glucose Monitoring and Capillary Blood Glucose after Hospital Discharge in Patients with Diabetes

The efficacy of continuous glucose monitoring (CGM) after hospital discharge in patients with diabetes (DM) has not been established. This prospective pilot study compared glycemic outcomes between capillary blood glucose (CBG) and CGM after hospital discharge. At discharge, a blinded Dexcom G6 CGM was inserted in 82 patients with DM. Patients were asked to perform CBG testing (3-4/d) and to return the CBG logs and CGM device after 10 days of discharge. Patients were treated with insulin ± oral antidiabetic agents and followed by their primary care team. A total of 65 patients (73.3%) returned their CGM and were included (age 58.3±11 years, 56% Males, HbA1c 8.7±2%, 98% DM2). Only 42 patients (51.2%) returned CBG logs (mean 3.01±0.9 CBG/d). CGM detection of hypoglycemia Disclosure R. J. Galindo: Consultant; Self; Abbott Diabetes, Boehringer Ingelheim International GmbH, Eli Lilly and Company, Novo Nordisk, Sanofi US, Valeritas, Inc., Research Support; Self; Dexcom, Inc., Novo Nordisk. M. C. Perez-guzman: None. S. Cardona: None. F. J. Pasquel: Consultant; Self; Boehringer Ingelheim Pharmaceuticals, Inc., Research Support; Self; Dexcom, Inc., Merck & Co., Inc. L. Peng: None. G. E. Umpierrez: Research Support; Self; AstraZeneca, Dexcom, Inc., Novo Nordisk. G. Davis: None. T. Idrees: None. M. A. Urrutia: None. K. W. Zamudio: None. B. S. Albury: None. A. Migdal: None. P. Vellanki: Consultant; Self; Boehringer Ingelheim Pharmaceuticals, Inc. M. Fayfman: None. Funding Dexcom, Inc.

154-OR: People Who Get More Hours of Sleep Have Lower Mean Glucose: Analysis of Continuous Glucose Monitoring and Fitbit Data in a Free-Living Population without Diabetes

Background: Sleep disorders are associated with having or developing type 2 diabetes, increased insulin resistance, and higher BMI. The relationship between sleep duration and continuous glucose monitoring (CGM) metrics has not been well studied. We examined the relationship between CGM-based metrics and sleep duration in a population without diabetes. Methods: Glucose metrics from a 10-day blinded CGM (Dexcom G6) wear and sleep metrics from a concurrent unblinded Fitbit wear were collected. Participants (mean (SD) age= 49.1 (10) years, BMI= 29.5 (8) kg/m2, 90% female, 14% African American) were recruited from an employee health plan in the Southeastern US. Forty-nine individuals without diabetes or prediabetes were included in this analysis. A linear regression model adjusting for age and BMI was used to evaluate the relationship between mean daytime glucose and nightly hours of sleep. Results: Participants recorded a median (IQR) 6.4 (6.1, 7.1) nightly hours of sleep, 6416 (5112, 8071) daily steps, and 12.7 (12.1, 13.5) daily sedentary hours. Mean (SD) mean daytime glucose was 112.7 (11.5) mg/dL and coefficient of variation was 15.4 (3) %. Mean daytime glucose was significantly and inversely associated with nightly hours of sleep (Beta= -3.1, p &amp;lt;0.05). Conclusion: In this population without diabetes, each additional one hour of sleep was associated with 3.1 mg/dL lower mean daytime glucose. This finding aligns with existing research on the protective effects of sleep on glycemic health and suggests it may be beneficial for people at risk for developing diabetes to improve their sleep habits. Longitudinal research where behavioral data is collected along with CGM can provide further insights into correlates of developing prediabetes and type 2 diabetes. Disclosure M. A. Crawford: Employee; Self; Dexcom, Inc. S. K. Pickus: Employee; Self; Dexcom, Inc. K. C. Hames: Employee; Self; Dexcom, Inc. M. Johnson: Employee; Self; Dexcom, Inc. I. J. Klein: None. G. J. Norman: Employee; Self; Dexcom, Inc.

441-P: The Association between Time-in-Range %, Measured by Continuous Glucose Monitoring (CGM) and Physical and Functional Indices amongst Older People with Type 2 Diabetes: A Cross-Sectional Study

People with diabetes have an increased risk for mobility disability and a more rapid decline in muscle mass (sarcopenia) compared to those without diabetes. Studies have demonstrated an association between A1C and Sarcopenia. Less is known regarding the relationship with Time In Range (TIR). Aims: To assess among older people with diabetes type 2, the cross sectional association between: TIR and aerobic capacity, gait speed, strength, balance and frailty indices. Methods: A cross sectional study, conducted amongst people with diabetes over the age of 60. Participants were provided with a blinded CGM system- (I Pro2 carelink, Medtronic) for 1 week and underwent elaborate physical-functional assessment in the beginning and at the end of that week. The association between the % of time in range (TIR) and several physical indices was determined using linear regression. Results: This analysis pertains to 81 men and women. After adjustment for age and gender, a 1% higher TIR (70-180) was associated with a 0.246 higher score on the 6-minute walk score, a measure of aerobic capacity and endurance (P-value=0.019) and 0.212 lower score on the Timed Up and Go(TUG), a measure of fall risk and balance (P-value=0.045). Conclusion: Higher % TIR is associated with better scores on indices of aerobic capacity and a measure predicting falls. Future studies are needed in order to elucidated if glucose levels are merely a marker of disease severity, or if there is possibly a causal relationship. Disclosure Y. Basson-shleymovich: None. T. Cukierman-yaffe: Advisory Panel; Self; AstraZeneca, Research Support; Self; Medtronic, MSD Corporation, Speaker’s Bureau; Self; Eli Lilly and Company, Medtronic, MSD Corporation, Novo Nordisk, Sanofi. T. Yahalom-peri: None. M. Azmon: None. N. Peltz-sinvani: None. Funding European Foundation for the Study of Diabetes; Medtronic

Afternoon aerobic and resistance exercise have limited impact on 24-h CGM outcomes in adults with type 1 diabetes: A secondary analysis

AimsThis study examined post-exercise glycemic variability in individuals with type 1 diabetes after acute bouts of resistance (RE) and aerobic exercise (AE) compared to a no-exercise day (CON). We hypothesized that exercise days would have greater glucose variability (standard deviation – SD, coefficient of variation – CV), and less time in range (TIR), compared to CON. MethodsA secondary analysis was conducted on previously collected data. Twelve active participants with type 1 diabetes performed three testing sessions in random order with at least 48 h in between: AE (45-min treadmill run at 60%VO2max), RE (three sets of eight repetitions, seven weight-lifting exercises), and CON (45-min no-exercise control). Interstitial glucose levels were monitored by blinded continuous glucose monitoring (CGM). Glycemic variability was evaluated for 0–6 h, overnight (00:00–06:00) and 24 h after exercise. ResultsMean CGM glucose, TIR, and time above/below range were similar among conditions (P > 0.05). Lower SD (0.8 [0.5–1.1], 1.4 [0.9–2.4]mmol/L, p = 0.009) and CV (11.4 [8.6–15.3], 23.4 [13.7–31.6]%, p = 0.007) were found overnight after AE versus CON. Otherwise, AE and RE had limited impact on post-exercise glycemia. ConclusionsAcute RE and AE bouts may have limited impact on post-exercise glycemic variability compared to rest in habitually active individuals with type 1 diabetes.

Ketogenic Diet in a Patient With Type 1 Diabetes Mellitus With Hypoglycemia Unawareness

Abstract Introduction: The high fat, low carbohydrate ketogenic diet has become increasingly popular in recent years for weight loss and glycemic control in patients with type 2 diabetes. Although prior studies have suggested this diet can improve glycemic control and decrease glucose variability, the impact of a ketogenic diet on rates of hypoglycemia in patients with hypoglycemia unawareness is not well described. Case Description: Our patient is a 37 year-old woman with Type 1 diabetes for 13 years complicated by hypoglycemia unawareness with HbA1c of 7.7%. Her insulin treatment regimen included insulin glargine 22 units daily, insulin aspart using a 1:15 carbohydrate ratio for prandial insulin dosing with a correction factor of 90. She had 5 episodes of severe hypoglycemia within the previous 3 months. The patient decided to resume a ketogenic diet given her previous improvement in glycemic control. Ketosis was confirmed using urine ketone strips performed by the patient. After 2 weeks on the ketogenic diet, a professional blinded continuous glucose monitor (CGM) was used for 4 weeks to monitor glycemic control. CGM data for weeks 1 and 2 showed overall stability of time in target glucose range [TIR, 60% and 69%, respectively], with a slight increase in time spent below range [TBR, 13% and 17%, respectively]. During week 3, the patient experienced a significant decline in TIR to 31%, and associated increase in hypoglycemia (TBR, 13% to 28%). In addition, glycemic variability increased during this time [CV (coefficient of variation), 40.6% during week 1 to 58.1% during week 3]. Patient did not experience symptoms concerning for DKA, and continued to have asymptomatic hypoglycemia despite reductions in her insulin doses during week 3. Following these dose adjustments, CGM data during week 4 were similar to week 1 (TIR 65%, TBR 10%, CV 35%). Patient stopped following the ketogenic diet after 6 weeks due to social factors. Conclusion: A ketogenic diet was associated with increased frequency of hypoglycemic events. In a patient with Type 1 diabetes and hypoglycemia unawareness, use of ketogenic diet may further increase the risk of severe hypoglycemia.

The Association Between Time in Range %, and Physical &amp; Functional Indices Amongst Older People With Type 2 Diabetes: A Cross Sectional Study

Abstract Diabetes is a major public health burden associated with high mortality, morbidity, hospitalization and health care services utilization rates. People with diabetes have an increased risk for mobility disability compared to those without diabetes, after controlling for age. People with diabetes also have a higher risk for falls and fractures. Data from the last several years suggests that this increased risk is not only due to diabetes co-morbidities but also due to an accelerated decline in physical capacity due to lower muscle quality and a more rapid decline in muscle mass (sarcopenia) and lower extremity strength over time. HBA1C is a measure of average glucose levels; however, it does not provide information about glycemic variability, or daily patterns of glycemia. In the last several years, several organizations have published consensus statements on the role of continuous glucose monitoring (CGM) in glucose control. The use of CGM has brought about the development of many glucose indices, amongst them is: Time In Range% (TIR) of 70–180 mg/dL (3.9–10 mmol/L). Less is known regarding the association between TIR and sarcopenia, muscle mass loss that leads to deterioration in mobility, disabilities and decline in physical indices in older people with diabetes. Aims: To assess among older people with diabetes type 2, the cross sectional association between: TIR and aerobic capacity, gait speed, strength, balance and frailty indices. Methods: A cross sectional study, conducted amongst people with diabetes over the age of 60. Participants were provided with a blinded CGM system- (I Pro2 carelink, Medtronic) for 1 week and underwent elaborate physical-functional assessment in the beginning and at the end of that week. The association between the % of time in range (Time in Range-TIR) and several physical indices was determined using linear regression. Results: This analysis pertains to 55 men and women who completed the evaluation. After adjustment for age and gender, we found that 1% increase in TIR was associated with a 0.341 higher score on the 30 second Sit to Stand score (a measure of lower extremity strength) (P-value=0.02), a 0.351 higher score on the BERG scale (a measure of balance) (P-value=0.01), a 0.271 lower score on the timed up and go score (a measure of fall risk and balance) (P-value=0.008), a 0.289 higher score on the 6-minute walk score (a measure of aerobic capacity and endurance) (P-value=0.02) and a 0.261 lower score on the 360 turn test (a measure of dynamic balance) (P-value=0.0004). The same was not observed for the relationship between HGA1C &amp; physical indices.

Dysglycemia in adults at risk for or living with non-insulin treated type 2 diabetes: Insights from continuous glucose monitoring.

BackgroundContinuous glucose monitoring (CGM) has demonstrable benefits for people living with diabetes, but the supporting evidence is almost exclusively from White individuals with type 1 diabetes. Here, we have quantified CGM profiles in Hispanic/Latino adults with or at-risk of non-insulin treated type 2 diabetes (T2D).Methods100 participants (79 female, 86% Hispanic/Latino [predominantly Mexican], age 54·6 [±12·0] years) stratified into (i) at risk of T2D, (ii) with pre-diabetes (pre-T2D), and (iii) with non-insulin treated T2D, wore blinded CGMs for 2 weeks. Beyond standardized CGM measures (average glucose, glucose variability, time in 70–140 mg/dL and 70–180 mg/dL ranges), we also examined additional CGM measures based on the time of day.FindingsStandardized CGM measures were significantly different for participants with T2D compared to at-risk and pre-T2D participants (p<0·0001). In addition, pre-T2D participants spent more time between 140 and 180 mg/dL during the day than at-risk participants (p<0·01). T2D participants spent more time between 140 and 180 mg/dL both during the day and overnight compared to at-risk and pre-T2D participants (both p<0·0001). Time in 70–140 mg/dL range during the day was significantly correlated with HbA1c (r=-0·72, p<0·0001), after adjusting for age, sex, BMI, and waist circumference (p<0·0001).InterpretationStandardized CGM measures show a progression of dysglycemia from at-risk of T2D, to pre-T2D, and to T2D. Stratifying CGM readings by time of day and the range 140–180 mg/dL provides additional metrics to differentiate between the groups.FundingUS Department of Agriculture (Grant #2018-33800-28404) and NSF PATHS-UP ERC (Award #1648451).

CopenFast trial: Faster-acting insulin Fiasp versus insulin NovoRapid in the treatment of women with type 1 or type 2 diabetes during pregnancy and lactation - a randomised controlled trial

IntroductionFaster-acting insulin aspart (Fiasp) is approved for use in pregnancy and lactation, but no clinical study has evaluated its effects during this life stage in women with pre-existing diabetes. The...

Cardiac arrhythmias and electrophysiologic responses during spontaneous hyperglycaemia in adults with type 1 diabetes mellitus

AimWe examined the effect of spontaneous hyperglycaemia in adults with type 1 diabetes mellitus (T1DM) and without history of cardiovascular disease on heart rate variability (HRV), cardiac repolarisation and incidence of cardiac arrhythmias. MethodsThirty-seven individuals with T1DM (age 17–50 years, 19 males, mean duration of diabetes 19.3 SD(9.6) years) underwent 96 h of simultaneous ambulatory 12-lead Holter ECG and blinded continuous interstitial glucose (IG) monitoring (CGM). HRV, QT interval and cardiac repolarisation were assessed during hyperglycaemia (IG ≥ 15 mmol/l) and compared with matched euglycaemia (IG 5−10 mmol/l) on a different day, separately during the day and night. Rates of arrhythmias were assessed by calculating incidence rate differences. ResultsSimultaneous ECG and CGM data were recorded for 2395 hours. During daytime hyperglycaemia vs euglycaemia the mean QTc interval duration was 404 SD(21)ms vs 407 SD(20)ms, P = 0.263. T-peak to T-end interval duration corrected for heart rate (TpTendc) shortened: 74.8 SD(16.1)ms vs 79.0 SD(14.8)ms, P = 0.033 and T-wave symmetry increased: 1.62 SD(0.33) vs 1.50 SD(0.39), P = 0.02. During night-time hyperglycaemia vs euglycaemia, the mean QTc interval duration was 401 SD(26)ms vs 404 SD(27)ms, P = 0.13 and TpTend shortened: 62.4 SD(12.0)ms vs 67.1 SD(11.8)ms, P = 0.003. The number of cardiac arrhythmias was low and confined to bradycardia and isolated ectopic beats. A considerable inter-subject and diurnal variability was observed. ConclusionsHyperglycaemia in individuals with T1DM without known cardiovascular disease was not associated with clinically important cardiac arrhythmias.

Nocturnal Hypoglycemia in Patients With Diabetes Discharged From ICUs: A Prospective Two-Center Cohort Study.

There is very limited information about glycemic control after discharge from the ICU. The aims of this study were to evaluate the prevalence of hypoglycemia in ICU survivors with type-2 diabetes and determine whether hypoglycemia is associated with cardiac arrhythmias. Prospective, observational, two-center study. Participants underwent up to 5 days of simultaneous blinded continuous interstitial glucose monitoring and ambulatory 12-lead electrocardiogram monitoring immediately after ICU discharge during ward-based care. Frequency of arrhythmias, heart rate variability, and cardiac repolarization markers were compared between hypoglycemia (interstitial glucose ≤ 3.5 mmol/L) and euglycemia (5-10 mmol/L) matched for time of day. Mixed medical-surgical ICUs in two geographically distinct university-affiliated hospitals. Patients with type-2 diabetes who were discharged from ICU after greater than or equal to 24 hours with greater than or equal to one organ failure and were prescribed subcutaneous insulin were eligible. Thirty-one participants (mean ± sd, age 65 ± 13 yr, glycated hemoglobin 64 ± 22 mmol/mol) were monitored for 101 ± 32 hours post-ICU (total 3,117 hr). Hypoglycemia occurred in 12 participants (39%; 95% CI, 22-56%) and was predominantly nocturnal (40/51 hr) and asymptomatic (25/29 episodes). Participants experiencing hypoglycemia had 2.4 ± 0.7 discrete episodes lasting 45 minutes (interquartile range, 25-140 min). Glucose nadir was less than or equal to 2.2 mmol/L in 34% of episodes. The longest episode of nocturnal hypoglycemia was 585 minutes with glucose nadir less than 2.2 mmol/L. Simultaneous electrocardiogram and continuous interstitial glucose monitoring recordings were obtained during 44 hours of hypoglycemia and 991 hours of euglycemia. Hypoglycemia was associated with greater risk of bradycardia but did not affect atrial or ventricular ectopics, heart rate variability, or cardiac repolarization. In ICU survivors with insulin-treated type-2 diabetes, hypoglycemia occurs frequently and is predominantly nocturnal, asymptomatic, and prolonged.