Body weight trends in individuals with type 1 diabetes using automated insulin delivery vs. traditional insulin pumps.

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Body weight trends in individuals with type 1 diabetes using automated insulin delivery vs. traditional insulin pumps.

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  • Research Article
  • Cite Count Icon 4
  • 10.2337/db24-144-or
144-OR: A Randomized Clinical Trial of Automated Insulin Delivery in Elderly with Type 1 Diabetes
  • Jun 14, 2024
  • Diabetes
  • Yogish C Kudva + 17 more

Background: Older adults with T1D are a growing population at risk for severe hypoglycemia. Automated insulin delivery (AID) approaches that can reduce risk have not been sufficiently evaluated in this population. Methods: We conducted a multicenter, randomized, crossover trial in adults ≥65 years with T1D experiencing hypoglycemia (>1.5% time < 70 mg/dL based on CGM). Participants completed 3 sequential 12-week periods of hybrid-closed (HCL) loop with Tandem Control-IQ technology, predictive low glucose suspend (PLGS) with Tandem Basal-IQ technology, and sensor augmented pump (SAP) insulin delivery. The primary outcome was % time <70 mg/dL measured by Dexcom G6 CGM. Results: 82 randomized participants were 65-86 years, 45% female, with a mean (±SD) baseline HbA1c 7.2±0.9%. AID was active a median of 97% of the time during the HCL period and 96% during the PLGS period. Mean (±SD) time <70 mg/dL was 2.49±1.78% at baseline, 1.58±0.95% during HCL, 1.67±0.96% during PLGS, and 2.57±1.54% during SAP (p<0.001 for HCL vs. SAP and PLGS vs. SAP; Table). CGM hypoglycemic events and time <54 mg/dL were reduced during HCL and PLGS compared to SAP. HCL improved time in range 70-180 mg/dL (TIR), time >180 mg/dL, time >250 mg/dL, and HbA1c compared to SAP and PLGS (Table). Conclusions: In older adults with T1D, HCL and PLGS both reduced hypoglycemia compared to SAP. HCL also improved TIR, hyperglycemia, and HbA1c compared to SAP and PLGS. Disclosure Y.C. Kudva: Research Support; Dexcom, Inc. Other Relationship; Tandem Diabetes Care, Inc., Medtronic. R. Henderson: None. L. Kanapka: None. R.S. Weinstock: Research Support; Eli Lilly and Company, Tandem Diabetes Care, Inc., Diasome, Amgen Inc., MannKind Corporation, Insulet Corporation, Novo Nordisk. Other Relationship; Dexcom, Inc. M.R. Rickels: Consultant; Vertex Pharmaceuticals Incorporated, Sernova, Corp. Research Support; Dompé. R.E. Pratley: Other Relationship; Bayer AG, Dompé, Endogenex, Inc., Gasherbrum Bio, Inc., Hengrui (USA) Ltd., Intas Pharmaceuticals Ltd., Eli Lilly and Company, Merck Sharp & Dohme Corp., Novo Nordisk, Novo Nordisk, Pfizer Inc., Rivus Pharmaceuticals Inc., Sun Pharmaceutical Industries Ltd. Consultant; AbbVie Inc., AstraZeneca. Other Relationship; Bayer HealthCare Pharmaceuticals, Inc., Biomea Fusion, Carmot Therapeutics, Inc., Corcept Therapeutics, Fractyl Health, Inc., Genprex. Consultant; Getz Pharma. Other Relationship; Lilly USA LLC, Sanofi. Consultant; Scholar Rock, Inc. N. Chaytor: None. K. Janess: None. D. Desjardins: None. V. Pattan: Stock/Shareholder; Tandem Diabetes Care, Inc. A. Peleckis: None. A. Casu: None. S. Rizvi: None. S. Bzdick: None. K.J. Whitaker: None. J.L. Jo Kamimoto: None. K. Miller: Consultant; Dexcom, Inc. Research Support; Dexcom, Inc. R. Beck: Consultant; Insulet Corporation. Research Support; Insulet Corporation. Consultant; Tandem Diabetes Care, Inc. Research Support; Tandem Diabetes Care, Inc. Consultant; Beta Bionics, Inc. Research Support; Beta Bionics, Inc., Dexcom, Inc., Bigfoot Biomedical, Inc. Consultant; Novo Nordisk. Research Support; Novo Nordisk, Eli Lilly and Company. Consultant; embecta, Vertex Pharmaceuticals Incorporated, Hagar, Ypsomed AG, Sanofi, Zucara Therapeutics, Sequel. Funding Funding provided by NIDDK. Study materials provided by Tandem Diabetes Care and Dexcom.

  • Research Article
  • 10.1210/jendso/bvae163.805
8223 Impact Of Automated Insulin Delivery On Fear Of Hypoglycemia In Pregnant And Puerperal Women With Type 1 Diabetes: A Systematic Review And Meta-Analysis
  • Oct 5, 2024
  • Journal of the Endocrine Society
  • Maria Antônia Costa Cruz Akabane + 6 more

Disclosure: M.C. Cruz Akabane: None. M. Yang Yu: None. H. Coelho: None. P. Romeiro: None. L.C. Hespanhol: None. T.L. Correa: None. V.L. De Menezes: None. Introduction: Patients with type 1 diabetes mellitus (T1DM) may experience a heightened fear of hypoglycemia, increasing risk of management and psychological complications. Automated Insulin delivery (AID) has shown improvements in glucose control in pregnant women with T1DM. However, its impact on patients’ concerns about hypoglycemia during gestation remains unclear. This study aimed to evaluate the impact of AID on patient-reported fear of hypoglycemia in pregnant and puerperal women. Methods: PubMed, Embase, and Cochrane Central databases were systematically searched in December 2023 for randomized controlled trials (RCTs) that compared AID to other standard therapies (ST) (sensor-augmented pump, multiple daily insulin injections, continuous glucose monitoring, and predictive low-glucose suspend) in adult pregnant or puerperal women with T1DM and reported the outcomes of (1) Hypoglycemia Fear Survey-II (HFS-II) total; (2) HFS-II worry scale; and (3) HFS-II behavior scale. A systematic review and meta-analysis of the findings were performed. Statistical analysis was performed using R version 4.3.2. Heterogeneity was examined with the Cochran Q test and I² statistics. Results: We included 5 RCTs (4 with pregnant women and 1 including puerperal women) in the final analysis, with a total of 150 participants, of whom 74 (49.34%) were on AID and 76 (50.66%) on ST. The mean age of the AID group was 32.2 (σ±0.8) years, while the ST was 31.74 (σ±0.99). The mean time since diagnosis of T1DM was 20.7 years (σ±1.98) in AID patients and 20.7 (σ±2.95) in ST. The mean gestational age at baseline in AID patients was 11.7 weeks (σ±2.19) and 11.5 weeks (σ±2.26) in ST. The follow-up period ranged between 4 and 12 weeks. The AID group had a baseline HFS-II behavior subscale mean score of 25.2 (σ±2.5), while ST had a mean of 24.9 (σ±2.61). AID patients presented a significant reduction of HFS-II behavior subscale score compared to ST (MD -1.84; 95% CI -3.29, -0.38; p= 0.01; I² = 0%). HFS-II worry scale score (MD -0.75; 95% CI -2.89, 1.38; p= 0.48; I² = 0%) and HFS-II total score (MD -0.19; 95% CI -2.72, 2.34; p= 0.77; I² = 0%) were not significantly different between groups. Conclusion: The significantly higher decrease in HFS-II behavior score while using AID suggests that this technology diminishes the fear of hypoglycemia, possibly enhancing pregnancy and puerperium behavior patterns in patients with T1DM. Nevertheless, there was no significant difference in improvement in the HFS-II total or worry subscale. AID seems to decrease the psychological burden of treatment, potentially improving patients’ quality of life and adherence to management plans. Keywords: Type 1 Diabetes, Hypoglycemia, Pregnancy Presentation: 6/2/2024

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  • Cite Count Icon 24
  • 10.1089/dia.2021.0542
Automated Insulin Delivery with SGLT2i Combination Therapy in Type 1 Diabetes
  • Jun 29, 2022
  • Diabetes Technology & Therapeutics
  • Jose Garcia-Tirado + 7 more

Background:Use of sodium-glucose cotransporter 2 inhibitors (SGLT2i) as adjunct therapy to insulin in type 1 diabetes (T1D) has been previously studied. In this study, we present data from the first free-living trial combining low-dose SGLT2i with commercial automated insulin delivery (AID) or predictive low glucose suspend (PLGS) systems.Methods:In an 8-week, randomized, controlled crossover trial, adults with T1D received 5 mg/day empagliflozin (EMPA) or no drug (NOEMPA) as adjunct to insulin therapy. Participants were also randomized to sequential orders of AID (Control-IQ) and PLGS (Basal-IQ) systems for 4 and 2 weeks, respectively. The primary endpoint was percent time-in-range (TIR) 70–180 mg/dL during daytime (7:00–23:00 h) while on AID (NCT04201496).Findings:A total of 39 subjects were enrolled, 35 were randomized, 34 (EMPA; n = 18 and NOEMPA n = 16) were analyzed according to the intention-to-treat principle, and 32 (EMPA; n = 16 and NOEMPA n = 16) completed the trial. On AID, EMPA versus NOEMPA had higher daytime TIR 81% versus 71% with a mean estimated difference of +9.9% (confidence interval [95% CI] 0.6–19.1); p = 0.04. On PLGS, the EMPA versus NOEMPA daytime TIR was 80% versus 63%, mean estimated difference of +16.5% (95% CI 7.3–25.7); p < 0.001. One subject on SGLT2i and AID had one episode of diabetic ketoacidosis with nonfunctioning insulin pump infusion site occlusion contributory.Interpretation:In an 8-week outpatient study, addition of 5 mg daily empagliflozin to commercially available AID or PLGS systems significantly improved daytime glucose control in individuals with T1D, without increased hypoglycemia risk. However, the risk of ketosis and ketoacidosis remains. Therefore, future studies with SGLT2i will need modifications to closed-loop control algorithms to enhance safety.

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  • Research Article
  • Cite Count Icon 8
  • 10.1089/dia.2023.2525.abstracts
The Official Journal of ATTD Advanced Technologies &amp; Treatments for Diabetes Conference 22‐25 February 2023 I Berlin &amp; Online
  • Feb 1, 2023
  • Diabetes Technology &amp; Therapeutics
  • P Randine + 2 more

The Official Journal of ATTD Advanced Technologies &amp; Treatments for Diabetes Conference 22‐25 February 2023 I Berlin &amp; Online

  • Research Article
  • Cite Count Icon 7
  • 10.1056/evidoa2400200
Automated Insulin Delivery in Older Adults with Type 1 Diabetes
  • Dec 23, 2024
  • NEJM Evidence
  • Yogish C Kudva + 18 more

BackgroundOlder adults with type 1 diabetes are at risk for serious hypoglycemia. Automated insulin delivery can reduce risk but has not been sufficiently evaluated in this population.MethodsWe conducted a multicenter, randomized crossover trial in adults older than or equal to 65 years of age with type 1 diabetes. Participants completed three 12-week periods of using hybrid closed loop, predictive low-glucose suspend, and sensor-augmented pump insulin delivery in a randomized order. The primary outcome was the percentage of time with continuous glucose monitoring glucose values less than 70 mg/dl.ResultsEighty-two participants between 65 and 86 years of age were randomly assigned: 45% were female; the baseline mean (±SD) glycated hemoglobin level was 7.2±0.9%; and the baseline percentage of time with glucose values less than 70 mg/dl was 2.49±1.78%. In the sensor-augmented pump, hybrid closed-loop, and predictive low-glucose suspend periods, percentages of time with glucose less than 70 mg/dl were 2.57±1.54%, 1.58±0.95%, and 1.67±0.96%, respectively. Compared with the sensor-augmented pump results, the mean difference with the hybrid closed-loop system was −1.05 percentage points (95% confidence interval [CI], −1.48 to −0.73 percentage points; P<0.001) and with the predictive low-glucose suspend system it was −0.93 percentage points (95% CI, −1.27 to −0.66 percentage points; P<0.001). Comparing a hybrid closed-loop system with a sensor-augmented pump, time in the range 70 to 180 mg/dl changed by 8.9 percentage points (95% CI, 7.4 to 10.4 percentage points) and the glycated hemoglobin level changed by 0.2 percentage points (95% CI, −0.3 to −0.1 percentage points). Serious adverse events were uncommon. Severe hypoglycemia occurred in 4% or less of participants; there were two hospitalizations for diabetic ketoacidosis.ConclusionsIn older adults with type 1 diabetes, automated insulin delivery decreased hypoglycemia compared with sensor-augmented pump delivery. (Funded by the National Institute of Diabetes and Digestive and Kidney Diseases and others; ClinicalTrials.gov number: NCT04016662.)

  • Research Article
  • Cite Count Icon 2
  • 10.1089/dia.2024.0560
Automated Insulin Delivery in Elderly with Type 1 Diabetes: A Prespecified Analysis of the Extension Phase.
  • Mar 11, 2025
  • Diabetes technology & therapeutics
  • Yogish C Kudva + 18 more

The Automated Insulin Delivery in Elderly with Type 1 Diabetes (AIDE T1D) trial randomized 82 adults ≥65 years with type 1 diabetes (T1D) to hybrid closed loop (HCL), predictive low glucose suspend (PLGS), and sensor-augmented pump (SAP) therapy in a randomized crossover trial. Seventy-five of the 78 completers joined an extension phase in which they were offered the pump mode of their choice for an additional 3 months. Mean age was 71 ± 4 years (range 65-86 years) and mean duration of T1D was 42 ± 17 years (range 1-68 years). Use of HCL was selected by 91%, PLGS by 8%, and continuous glucose monitoring with injections by 1%. For participants selecting HCL, time-in-range 70-180 mg/dL was similar in the randomized controlled trial and extension phase (mean 75% ± 10%). One severe hypoglycemic event was reported. HCL was preferred over PLGS or SAP and remained effective in older adults with T1D. Clinical Trial Registration: NCT04016662.

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  • Research Article
  • Cite Count Icon 28
  • 10.1186/s13098-023-01144-4
Glucose control and psychosocial outcomes with use of automated insulin delivery for 12 to 96 weeks in type 1 diabetes: a meta-analysis of randomised controlled trials
  • Sep 28, 2023
  • Diabetology & Metabolic Syndrome
  • Amanda Godoi + 14 more

BackgroundGlycaemic control of Type 1 Diabetes Mellitus (T1DM) remains a challenge due to hypoglycaemic episodes and the burden of insulin self-management. Advancements have been made with the development of automated insulin delivery (AID) devices, yet, previous reviews have only assessed the use of AID over days or weeks, and potential benefits with longer time of AID use in this population remain unclear.Methods We performed a systematic review and meta-analysis of randomised controlled trials comparing AID (hybrid and fully closed-loop systems) to usual care (sensor augmented pumps, multiple daily insulin injections, continuous glucose monitoring and predictive low-glucose suspend) for adults and children with T1DM with a minimum duration of 3 months. We searched PubMed, Embase, Cochrane Central, and Clinicaltrials.gov for studies published up until April 4, 2023. Main outcomes included time in range 70–180 mg/dL as the primary outcome, and change in HbA1c (%, mmol/mol), glucose variability, and psychosocial impact (diabetes distress, treatment satisfaction and fear of hypoglycaemia) as secondary outcomes. Adverse events included diabetic ketoacidosis (DKA) and severe hypoglycaemia. Statistical analyses were conducted using mean differences and odds ratios. Sensitivity analyses were performed according to age, study duration and type of AID device. The protocol was registered in PROSPERO, CRD42022366710.ResultsWe identified 25 comparisons from 22 studies (six crossover and 16 parallel designs) including a total of 2376 participants (721 in adult studies, 621 in paediatric studies, and 1034 in combined studies) which were eligible for analysis. Use of AID devices ranged from 12 to 96 weeks. Patients using AID had 10.87% higher time in range [95% CI 9.38 to 12.37; p < 0.0001, I2 = 87%) and 0.37% (4.77 mmol/mol) lower HbA1c (95% CI − 0.49% (− 6.39 mmol/mol) to – 0.26 (− 3.14 mmol/mol); p < 0·0001, I2 = 77%]. AID systems decreased night hypoglycaemia, time in hypoglycaemia and hyperglycaemia and improved patient distress, with no increase in the risk of DKA or severe hypoglycaemia. No difference was found regarding treatment satisfaction or fear of hypoglycaemia. Among children, there was no difference in glucose variability or time spent in hypoglycaemia between the use of AID systems or usual care. In sensitivity analyses, results remained consistent with the overall analysis favouring AID.ConclusionThe use of AID systems over 12 weeks, regardless of technical or clinical differences, improved glycaemic outcomes and diabetes distress without increasing the risk of adverse events in adults and children with T1DM.

  • Research Article
  • Cite Count Icon 34
  • 10.2337/dc22-1217
Biobehavioral Changes Following Transition to Automated Insulin Delivery: A Large Real-life Database Analysis
  • Sep 20, 2022
  • Diabetes Care
  • Boris P Kovatchev + 3 more

OBJECTIVETo document glycemic and user-initiated bolus changes following transition from predictive low glucose suspend (PLGS) system to automated insulin delivery (AID) system during real-life use.RESEARCH DESIGN AND METHODSWe conducted analysis of 2,329,166 days (6,381 patient-years) of continuous glucose monitoring (CGM) and insulin therapy data for 19,354 individuals with type 1 Diabetes, during 1-month PLGS use (Basal-IQ technology) followed by 3-month AID use (Control-IQ technology). Baseline characteristics are as follows: 55.4% female, age (median/quartiles/range) 39/19–58/1–92 years, mean ± SD glucose management indicator (GMI) 7.5 ± 0.8. Primary outcome was time in target range (TIR) (70–180 mg/dL). Secondary outcomes included CGM-based glycemic control metrics and frequency of user-initiated boluses.RESULTSCompared with PLGS, AID increased TIR on average from 58.4 to 70.5%. GMI and percent time above and below target range improved as well: from 7.5 to 7.1, 39.9 to 28.1%, and 1.66 to 1.46%, respectively; all P values <0.0001. Stratification of outcomes by age and baseline GMI revealed clinically significant differences. Glycemic improvements were most pronounced in those <18 years old (TIR improvement 14.0 percentage points) and those with baseline GMI >8.0 (TIR improvement 13.2 percentage points). User-initiated correction boluses decreased from 2.7 to 1.8 per day, while user-initiated meal boluses remained stable at 3.6 to 3.8 per day.CONCLUSIONSObserved in real life of >19,000 individuals with type 1 diabetes, transitions from PLGS to AID resulted in improvement of all glycemic parameters, equivalent to improvements observed in randomized clinical trials, and reduced user-initiated boluses. However, glycemic and behavioral changes with AID use may differ greatly across different demographic and clinical groups.

  • Research Article
  • Cite Count Icon 13
  • 10.1177/19322968231156601
Use of Continuous Glucose Monitoring in Pump Therapy Sensor Augmented Pump or Automated Insulin Delivery in Different Age Groups (0.5 to
  • Feb 25, 2023
  • Journal of diabetes science and technology
  • Louisa Van Den Boom + 9 more

Insulin pump, continuous glucose monitoring (CGM), and sensor augmented pump (SAP) technology have evolved continuously leading to the development of automated insulin delivery (AID) systems. Evaluation of the use of diabetes technologies in people with T1D from January 2018 to December 2021. A patient registry (Diabetes Prospective Follow-up Database [DPV]) was analyzed for use of SAP (insulin pump + CGM ≥90 days, no automated dose adjustment) and AID (HCL or LGS/PLGS). In total 46,043 people with T1D aged 0.5 to <26 years treated in 416 diabetes centers (Germany, Austria, Luxemburg, and Switzerland) were included and stratified into 4 groups A-D according to age. Additionally, TiR and HbA1c were analyzed. From 2018 to 2021, there was a significant increase from 28.7% to 32.9% (sensor augmented pump [SAP]) and 3.5% to 16.6% (AID) across all age groups, with the most frequent use in group A (<7 years, 38.8%-40.2% and 10.3%-28.5%). A similar increase in SAP and AID use was observed in groups B (7 to <11 years) and C (11 to <16 years): B: +15.8 PP, C: +15.9 PP. HbA1c improved significantly in groups C and D (16 to <26 years) (both P < .01). Time in range (TiR) increased in all groups (A: +3 PP; B: +5 PP; C: +5 PP; D: +5 PP; P < 0.01 for each group). Insulin pumps (61.0% versus 53.4% male) and SAP (33.5% versus 28.9% male) are used more frequently in females. In recent years, we found an increasing use of new diabetes technologies and an improvement in metabolic control (TiR) across all age groups.

  • Research Article
  • Cite Count Icon 2
  • 10.2337/db22-289-or
289-OR: Automated Insulin Delivery Use among 12,065 T1D Exchange Registry Participants
  • Jun 1, 2022
  • Diabetes
  • Jingwen Liu + 9 more

Use of automated insulin delivery (AID) in people with type 1 diabetes (T1D) has increased in recent years. We analyzed data from the T1D Exchange Registry - an online longitudinal study following adults and children with T1D - to describe characteristics of AID use and its association with self-reported HbA1c, occurrence of diabetic ketoacidosis (DKA) symptoms, and occurrence of severe hypoglycemia events (SHE) . Of 12,065 participants (69.5% female, 87.5% non-Hispanic White, mean age 37.9 yrs, mean T1D duration 19.9 yrs) , 26.4% reported using AID, 43.6% using insulin pump without AID, and 30.0% using multiple daily injections (MDI) . Private insurance was reported in 77.4% of AID users, 74.9% pump without AID, and 66.3% MDI. Among the 3,185 AID users, 50.6% used predictive low glucose suspend (PLGS) features, including Medtronic 640G and Tandem Basal-IQ; 49.4% used hybrid closed-loop (HCL) , including DIY looping, Medtronic Auto Mode, and Tandem Control-IQ. Average HbA1c was lower in AID users than those using MDI and pump without AID; Incidence of SHE was lower among HCL users compared with PLGS users and AID users compared with MDI users (Table 1) . These cross-sectional real-world data support findings of previous clinical studies showing significant improvements in HbA1c with AID use, with HCL use providing additional protection against SHE. Disclosure J.Liu: None. W.Wolf: None. K.Miller: Research Support; Dexcom, Inc., Tandem Diabetes Care, Inc. C.Kelly: None. K.S.M.Chapman: None. M.Peter: None. D.Finan: None. H.Nguyen: None. K.Laferriere: None. C.Leon: None.

  • Research Article
  • 10.1089/dia.2025.0057
The Importance of Instigating Automated Insulin Delivery Systems at Onset of Type 1 Diabetes: 1-Year Follow-Up of Children and Adolescents from Two Tertiary Pediatric Diabetes Centers.
  • Mar 20, 2025
  • Diabetes technology & therapeutics
  • Ivana Rabbone + 7 more

To evaluate differences in glucometrics in children and adolescents assigned to automated insulin delivery (AID), predictive low-glucose suspend (PLGS), or multiple daily injections (MDI) in the first month of diabetes management. In this real-world prospective cohort study, all subjects aged 0-18 years with diabetes onset between January 1, 2020, and June 30, 2023, were assigned to MDI (n = 24), PLGS (n = 28), or AID (n = 32) but were allowed to switch after the first 3 months. The primary outcome was HbA1c after 12 months. The mean age (n = 84) was 7.9 ± 3.9 years (range 1-18 years), and 58 were male. After 12 months, HbA1c was significantly lower in the AID group than in the PLGS or MDI groups (AID 6.6% ± 0.6% vs. PLGS 7.4% ± 1.1% vs. MDI 7.6% ± 1.5%, P = 0.001), with better time in range (P = 0.001), time below range (P = 0.01), time above range (P = 0.001), coefficient of variation (P = 0.01), and glucose management indicator (P = 0.001). AID is best started at diabetes onset to optimize glucose control outcomes.

  • Preprint Article
  • 10.2337/figshare.20645448
Bio-Behavioral Changes Following Transition to Automated Insulin Delivery: A Large Real-Life Database Analysis
  • Sep 20, 2022
  • Boris P Kovatchev + 3 more

&lt;p&gt; &lt;/p&gt; &lt;p&gt;&lt;u&gt;Objective:&lt;/u&gt; Document glycemic and user-initiated bolus changes following transition from predictive-low glucose suspend (PLGS) system to automated insulin delivery (AID) system during real-life use.&lt;/p&gt; &lt;p&gt;&lt;u&gt;Research Design and Methods:&lt;/u&gt; Analysis of 2,329,166 days (6,381 patient-years) of continuous glucose monitoring (CGM) and insulin therapy data for 19,354 individuals with Type 1 Diabetes, during 1-month PLGS (Basal-IQ technology) use followed by 3-month AID use (Control-IQ technology). Baseline characteristics: 55.4 percent female, age (median/quartiles/range) 39/19-58/1-92 years, glucose management indicator (GMI) 7.5±0.8. Primary outcome: time in target range (TIR 70-180mg/dL). Secondary outcomes: CGM-based glycemic control metrics; frequency of user-initiated boluses.&lt;/p&gt; &lt;p&gt;&lt;u&gt;Results&lt;/u&gt;: Compared to PLGS, AID increased TIR on average from 58.4 to 70.5 percent. GMI and percent time above/below target range improved as well, 7.5 to 7.1; 39.9 to 28.1 percent, and 1.66 to 1.46 percent, respectively, all p-levels &lt;0.0001. Stratification of outcomes by age and baseline GMI revealed clinically significant differences. Glycemic improvements were most pronounced in those &lt;18 years old (TIR improvement 14.0 percentage points), and those with baseline GMI &gt;8.0 (TIR improvement 13.2 percentage points). User-initiated correction boluses decreased from 2.7 to 1.8 per day, while user-initiated meal boluses remained stable at 3.6 to 3.8 per day.&lt;/p&gt; &lt;p&gt;&lt;u&gt;Conclusions:&lt;/u&gt; Observed in real life of over 19,000 individuals with type 1 diabetes, transitions from PLGS to AID resulted in improvement of all glycemic parameters, equivalent to improvements observed in randomized clinical trials, and reduced user-initiated boluses. However, glycemic and behavioral changes with AID use may differ greatly across different demographic and clinical groups. &lt;/p&gt;

  • Preprint Article
  • 10.2337/figshare.20645448.v1
Bio-Behavioral Changes Following Transition to Automated Insulin Delivery: A Large Real-Life Database Analysis
  • Sep 20, 2022
  • Boris P Kovatchev + 3 more

&lt;p&gt; &lt;/p&gt; &lt;p&gt;&lt;u&gt;Objective:&lt;/u&gt; Document glycemic and user-initiated bolus changes following transition from predictive-low glucose suspend (PLGS) system to automated insulin delivery (AID) system during real-life use.&lt;/p&gt; &lt;p&gt;&lt;u&gt;Research Design and Methods:&lt;/u&gt; Analysis of 2,329,166 days (6,381 patient-years) of continuous glucose monitoring (CGM) and insulin therapy data for 19,354 individuals with Type 1 Diabetes, during 1-month PLGS (Basal-IQ technology) use followed by 3-month AID use (Control-IQ technology). Baseline characteristics: 55.4 percent female, age (median/quartiles/range) 39/19-58/1-92 years, glucose management indicator (GMI) 7.5±0.8. Primary outcome: time in target range (TIR 70-180mg/dL). Secondary outcomes: CGM-based glycemic control metrics; frequency of user-initiated boluses.&lt;/p&gt; &lt;p&gt;&lt;u&gt;Results&lt;/u&gt;: Compared to PLGS, AID increased TIR on average from 58.4 to 70.5 percent. GMI and percent time above/below target range improved as well, 7.5 to 7.1; 39.9 to 28.1 percent, and 1.66 to 1.46 percent, respectively, all p-levels &lt;0.0001. Stratification of outcomes by age and baseline GMI revealed clinically significant differences. Glycemic improvements were most pronounced in those &lt;18 years old (TIR improvement 14.0 percentage points), and those with baseline GMI &gt;8.0 (TIR improvement 13.2 percentage points). User-initiated correction boluses decreased from 2.7 to 1.8 per day, while user-initiated meal boluses remained stable at 3.6 to 3.8 per day.&lt;/p&gt; &lt;p&gt;&lt;u&gt;Conclusions:&lt;/u&gt; Observed in real life of over 19,000 individuals with type 1 diabetes, transitions from PLGS to AID resulted in improvement of all glycemic parameters, equivalent to improvements observed in randomized clinical trials, and reduced user-initiated boluses. However, glycemic and behavioral changes with AID use may differ greatly across different demographic and clinical groups. &lt;/p&gt;

  • Research Article
  • Cite Count Icon 10
  • 10.1089/dia.2015.1525
Abstracts from ATTD 20158th International Conference on Advanced Technologies &amp; Treatments for DiabetesParis, France—February 18–21, 2015
  • Feb 1, 2015
  • Diabetes Technology &amp; Therapeutics
  • Dimitri Boiroux + 8 more

Abstracts from ATTD 20158th International Conference on Advanced Technologies &amp; Treatments for DiabetesParis, France—February 18–21, 2015

  • Research Article
  • 10.2337/db25-930-p
930-P: The Impact of Insulin Delivery Modality on Fasting Experience, Glycemic Control, and Fear of Hypoglycemia in the Month of Ramadan in People with T1D—A Prospective, Multicenter Study from Saudi Arabia
  • Jun 20, 2025
  • Diabetes
  • Mohammed Al-Sofiani + 10 more

Introduction and Objective: Most people with type 1 diabetes (PWT1D) are advised to not fast during Ramadan because of dysglycemia risks. We compared efficacy, safety profiles, and fear of hypoglycemia (FH) during Ramadan fasting in users of 4 insulin delivery modalities. Methods: Four treatment groups were compared: automated insulin delivery (AID) (n=114), sensor augmented pump (SAP) with predictive-low-glucose suspend (PLGS) (n=4), sensor-unintegrated pump (SUP) (n=24), and multiple daily injections (MDI)+continuous glucose monitoring (CGM) (n=136). Results: Pre/during-Ramadan percent time in range (TIR) for the AID, SAP-PLGS, SUP, and MDI-CGM groups was 73.2/73.4, 62/65.5, 57.8/54.6, and 52.1/47.4. The Pre/during Ramadan Glycemia Risk Index (GRI) for the AID, SAP-PLGS, SUP, and MDI-CGM groups was 30/29, 43/35, 52/55, and 60/64. The proportion of PWT1D achieving a “double target of fasting” (fasting was broken ≤2 days because of diabetes and TIR was &amp;gt;70%) for the AID, SAP-PLGS, SUP, and MDI-CGM groups was 46.5%, 25%, 12.5%, and 7.35%. AID system users were 22 times as likely to achieve the double target compared to MDI+CGM users after adjusting for age, gender, employment/insurance status, educational level, and diabetes duration. While the overall FH score did not significantly differ across the four groups (overall p&amp;gt;0.05), AID users had the lowest score and MDI had the highest score on the behavior subscale of the FH survey. Conclusion: Use of AID during Ramadan fasting was associated with fasting the most days of Ramadan, best glycemic control, and the least frequent hypoglycemia avoidance behaviors. The International Diabetes Federation/Diabetes and Ramadan International Alliance risk calculator should assign a lower risk score for AID technology when used by PWT1D Disclosure M. Al-Sofiani: Advisory Panel; Medtronic. Speaker's Bureau; Insulet Corporation, Abbott, Lilly Diabetes. Advisory Panel; Dexcom, Inc., Roche Diabetes Care. Speaker's Bureau; Sanofi. Research Support; Medtronic. Speaker's Bureau; Vitalaire. S. Alharthi: None. M. Alsuhaibani: None. A.M. Alhashem: None. A.M. Almurashi: None. T.H. Almigbal: None. R. Alamoudi: None. H.A. Zarif: Other Relationship; Abbott, Medtronic. N. Alzaman: None. M. Almehthel: Advisory Panel; Novo Nordisk. Speaker's Bureau; Novo Nordisk. Research Support; Novo Nordisk. Advisory Panel; Sanofi. Speaker's Bureau; Sanofi. Research Support; Sanofi. Speaker's Bureau; Lilly Diabetes. Advisory Panel; Abbott. Speaker's Bureau; Abbott. Advisory Panel; Dexcom, Inc. Speaker's Bureau; Bayer Pharmaceuticals, Inc. D.C. Klonoff: Consultant; Synchneuro, Thirdwayv, Tingo, Afon, embecta, Glucotrack, Lifecare, Novo Nordisk, Samsung.

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