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  • 1
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    Online Resource
    Automated Insulin Delivery in Women with Pregnancy Complicated by Type 1 Diabetes
    Massachusetts Medical Society ; 2023
    In:  New England Journal of Medicine
    Details
    In: New England Journal of Medicine, Massachusetts Medical Society
    Type of Medium: Online Resource
    ISSN: 0028-4793 , 1533-4406
    URL: Article
    DOI: 10.1056/NEJMoa2303911
    RVK:
    XA 10000
    Language: English
    Publisher: Massachusetts Medical Society
    Publication Date: 2023
    detail.hit.zdb_id: 1468837-2
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  • 2
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    Automated closed-loop insulin delivery for the management of type 1 diabetes during pregnancy: the AiDAPT RCT
    National Institute for Health and Care Research ; 2024
    In:  Efficacy and Mechanism Evaluation
    Details
    In: Efficacy and Mechanism Evaluation, National Institute for Health and Care Research
    Abstract: There are over 2000 pregnancies annually in women with type 1 diabetes in the UK. Despite recent improvements in diabetes technology, most women cannot achieve and maintain the recommended pregnancy glucose targets. Thus, one in two babies experience complications requiring neonatal care unit admission. Recent studies demonstrate that hybrid closed-loop therapy, in which algorithms adjust insulin delivery according to continuous glucose measurements, is effective for managing type 1 diabetes outside of pregnancy, but efficacy during pregnancy is unclear. Objective To examine the clinical efficacy of hybrid closed-loop compared to standard insulin therapy in pregnant women with type 1 diabetes. Design A multicentre, parallel-group, open-label, randomised, controlled trial in pregnant women with type 1 diabetes. Setting Nine antenatal diabetes clinics in England, Scotland and Northern Ireland. Participants Pregnant women with type 1 diabetes and above-target glucose levels, defined as glycated haemoglobin A1c of ≥ 48 mmol/mol (6.5%) in early pregnancy. Interventions A hybrid closed-loop system compared to standard insulin delivery (via insulin pump or multiple daily injections) with continuous glucose monitoring. Outcome measures The primary outcome is the difference between the intervention and control groups in percentage time spent in the pregnancy glucose target range (3.5–7.8 mmol/l) as measured by continuous glucose monitoring from 16 weeks’ gestation until delivery. Secondary outcomes include overnight time in range, time above range ( 〉  7.8 mmol/l), glycated haemoglobin A1c, safety outcomes (diabetic ketoacidosis, severe hypoglycaemia, adverse device events), psychosocial functioning obstetric and neonatal outcomes. Results The percentage of time that maternal glucose levels were within target range was higher with closed-loop than standard insulin therapy: 68.2 ± 10.5 in closed-loop and 55.6 ± 12.5 in the control group (mean‑adjusted difference 10.5 percentage points, 95% confidence interval 7.0 to 14.0; p   〈 0.001). Results were consistent in secondary outcomes, with less time above range (−10.2%, 95% confidence interval −13.8 to −6.6%; p   〈 0.001), higher overnight time in range (12.3%, 95% confidence interval 8.3 to 16.2%; p   〈 0.001) and lower glycated haemoglobin A1c (−0.31%, 95% confidence interval −0.50 to −0.12%; p   〈 0.002) all favouring closed-loop. The treatment effect was apparent from early pregnancy and consistent across clinical sites, maternal glycated haemoglobin A1c categories and previous insulin regimen. Maternal glucose improvements were achieved with 3.7 kg less gestational weight gain and without additional hypoglycaemia or total daily insulin dose. There were no unanticipated safety problems (six vs. five severe hypoglycaemia cases, one diabetic ketoacidosis per group) and seven device-related adverse events associated with closed-loop. There were no between-group differences in patient-reported outcomes. There was one shoulder dystocia in the closed-loop group and four serious birth injuries, including one neonatal death in the standard care group. Limitations Our results cannot be extrapolated to closed-loop systems with higher glucose targets, and our sample size did not provide definitive data on maternal and neonatal outcomes. Conclusions Hybrid closed-loop therapy significantly improved maternal glycaemia during type 1 diabetes pregnancy. Our results support National Institute for Health and Care Excellence guideline recommendations that hybrid closed-loop therapy should be offered to all pregnant women with type 1 diabetes. Future work Future trials should examine the effectiveness of hybrid closed-loop started before pregnancy, or as soon as possible after pregnancy confirmation. Trial registration This trial is registered as ISRCTN56898625. Funding This award was funded by the National Institute of Health and Care Research (NIHR) Efficacy and Mechanism Evaluation (EME) programme (NIHR award ref: 16/35/01) and is published in full in Efficacy and Mechanism Evaluation ; Vol. 11, No. 7. See the NIHR Funding and Awards website for further award information. Dexcom supplied the continuous glucose monitoring systems used by AiDAPT intervention- and control-arm participants at reduced cost.
    Type of Medium: Online Resource
    ISSN: 2050-4373
    URL: Article
    DOI: 10.3310/WCHZ4201
    Language: English
    Publisher: National Institute for Health and Care Research
    Publication Date: 2024
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  • 3
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    108-LB: Randomized Trial of Automated Insulin Delivery in Pregnant Women with Type 1 Diabetes
    American Diabetes Association ; 2023
    In:  Diabetes Vol. 72, No. Supplement_1 ( 2023-06-20)
    Details
    In: Diabetes, American Diabetes Association, Vol. 72, No. Supplement_1 ( 2023-06-20)
    Abstract: Objective: To examine the clinical efficacy of automated insulin delivery (AID) during type 1 diabetes (T1D) pregnancy. Methods and Outcomes: We randomized pregnant women with T1D from nine UK clinical sites to hybrid closed-loop (CamAPS FX) or standard insulin therapy with continuous glucose monitoring. The primary outcome was the between-group difference in percentage time in the pregnancy-specific target glucose range (63-140mg/dl) from 16-weeks’ gestation until delivery. Analyses were performed according to intention-to-treat principles. Key secondary outcomes included overnight time-in-range (TIR), time spent hyperglycaemic (time-above-range, TAR & gt;140mg/dl), HbA1c and safety events. Results: 124 participants (aged 31.1 ± 5.3yrs, HbA1c 7.7 ± 1.2%, T1D duration 2-31yrs, weight 49.0-138.0kg, total daily insulin doses 0.3-1.4units/kg) were randomized. The percentage of time that maternal glucose levels were within target was higher during AID than standard insulin therapy; mean between-group treatment difference 10%; 95% CI 7 to 10%; p & lt; 0.001. Participants randomized to AID had larger reductions in hyperglycemia (AID vs control -11%; 95% CI -14 to - 7%; p & lt;0.001), higher overnight time-in-range; (13%; 95% CI 9 to 17%; p & lt;0.001), and lower HbA1c (-0.34%; 95%CI -0.52 to -0.15%; p & lt;0.001), without additional insulin, weight gain or hypoglycemia. The treatment effect was apparent from early pregnancy, consistent across clinical sites, maternal HbA1c categories and previous insulin pump or injections. A significantly higher percent of AID participants reached CGM targets (TIR & gt;70%: 46% vs 10%; p & lt;0.001 and TAR & lt;25%: 37% vs 11%; p=0.007 [AID vs. control]). One neonatal death that was unrelated to standard insulin therapy occurred. Conclusions: AID significantly improved maternal glycemia throughout T1D pregnancy. Our results support proposed NICE guideline recommendations that hybrid closed-loop therapy should be offered to all pregnant women with T1D. Disclosure H. R. Murphy: Advisory Panel; Medtronic, Research Support; Dexcom, Inc. L. Shepstone: None. M. E. Wilinska: Consultant; CamDiab Ltd. S. Bergford: None. J. Sibayan: None. C. Kollman: Research Support; Insulet Corporation, Dexcom, Inc., Tandem Diabetes Care, 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. R. Hovorka: Advisory Panel; Ypsomed AG, Consultant; Abbott Diabetes, B. Braun, Speaker's Bureau; Eli Lilly and Company, Stock/Shareholder; CamDiab Ltd. T. T. M. Lee: None. C. Collett: None. S. Hartnell: Advisory Panel; Dexcom, Inc., Medtronic, Consultant; CamDiab Ltd., Other Relationship; AskDiabetes Ltd, Speaker's Bureau; Abbott Diabetes, Ypsomed AG. E. M. Scott: Research Support; Abbott Diabetes, Speaker's Bureau; Abbott Diabetes. R. S. Lindsay: None. K. F. Hunt: None. D. R. Mccance: None. M. Hammond: None. Funding National Institute for Health Research (16/35/01); JDRF (22-2013-266, 2-RSC-2019-828-M-N); Diabetes Research and Wellness Foundation (SECF/21 to T.T.M.L.)
    Type of Medium: Online Resource
    ISSN: 0012-1797
    URL: Article
    DOI: 10.2337/db23-108-LB
    Language: English
    Publisher: American Diabetes Association
    Publication Date: 2023
    detail.hit.zdb_id: 1501252-9
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  • 4
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    Assessing non‐adjunctive CGM safety at home and in new markets (ANSHIN)
    Wiley ; 2023
    In:  Endocrinology, Diabetes & Metabolism Vol. 6, No. 3 ( 2023-05)
    Details
    In: Endocrinology, Diabetes & Metabolism, Wiley, Vol. 6, No. 3 ( 2023-05)
    Abstract: Continuous glucose monitoring (CGM) can guide treatment for people with type 1 (T1D) and type 2 diabetes (T2D). The ANSHIN study assessed the impact of non‐adjunctive CGM use in adults with diabetes using intensive insulin therapy (IIT). Materials and Methods This single‐arm, prospective, interventional study enrolled adults with T1D or T2D who had not used CGM in the prior 6 months. Participants wore blinded CGMs (Dexcom G6) during a 20‐day run‐in phase, with treatment based on fingerstick glucose values, followed by a 16‐week intervention phase and then a randomized 12‐week extension phase with treatment based on CGM values. The primary outcome was change in HbA1c. Secondary outcomes were CGM metrics. Safety endpoints were the number of severe hypoglycaemic (SH) and diabetic ketoacidosis (DKA) events. Results Of the 77 adults enrolled, 63 completed the study. Those enrolled had mean (SD) baseline HbA1c of 9.8% (1.9%), 36% had T1D, and 44% were ≥65 years old. Mean HbA1c decreased by 1.3, 1.0 and 1.0 percentage points for participants with T1D, T2D or age ≥65, respectively ( p   〈  .001 for each). CGM‐based metrics including time in range also improved significantly. SH events decreased from the run‐in period (67.3 per 100 person‐years) to the intervention period (17.0 per 100 person‐years). Three DKA events unrelated to CGM use occurred during the total intervention period. Conclusions Non‐adjunctive use of the Dexcom G6 CGM system improved glycaemic control and was safe for adults using IIT.
    Type of Medium: Online Resource
    ISSN: 2398-9238 , 2398-9238
    URL: Issue
    URL: Article
    DOI: 10.1002/edm2.v6.3
    DOI: 10.1002/edm2.414
    Language: English
    Publisher: Wiley
    Publication Date: 2023
    detail.hit.zdb_id: 2934368-9
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  • 5
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    575-P: Do Overnight Dips Exist following Afternoon Exercise? Factors Associated with Nocturnal Hypoglycemia in the Type 1 Diabetes Exercise Initiative Pediatric (T1DexiP) Study
    American Diabetes Association ; 2023
    In:  Diabetes Vol. 72, No. Supplement_1 ( 2023-06-20)
    Details
    In: Diabetes, American Diabetes Association, Vol. 72, No. Supplement_1 ( 2023-06-20)
    Abstract: Some controlled studies have associated afternoon exercise with a biphasic pattern of hypoglycemia (hypo) risk: during exercise and 7-11hrs later. We explored factors relating to nocturnal hypo following afternoon exercise (12PM-6PM) among youth in the observational T1DexiP study. Youth with T1D (n=203; [mean±SD] age14±2 yrs; HbA1c=7.0± 1.2%; 42% female; T1D duration 5.4±3.9yrs; 12% on MDI and 58% on AID) wore a continuous glucose monitor, an activity monitor and logged activity using the Bant app for 10 days. Repeated measures logistic regression adjusted for bedtime glucose and % time below range (TBR & lt; 70mg/dL) in the prior 24hrs. Of the 833 afternoon exercise sessions, 14% led to nocturnal hypo (≥15 consecutive minutes & lt;70 mg/dL). Median TBR was higher in the 24hrs before exercise in youth who developed nocturnal hypo vs those who did not (3% vs 1%), while pre-exercise glucose level, heart rate, and insulin on board were similar. Nocturnal hypo risk was higher among teens who exercised more often during the study (Table). A trend for lower risk was noted with AID use. Our model revealed that participants who exercised & gt;90 min/day had increased risk of nocturnal hypoglycemia, while AID use may reduce risk. This suggests algorithmically modulated insulin delivery may help to mitigate the impact of afternoon exercise on nocturnal glycemia. Disclosure J.Sherr: Advisory Panel; Bigfoot Biomedical, Inc., Insulet Corporation, Medtronic, Vertex Pharmaceuticals Incorporated, Cecelia Health, StartUp Health T1D Moonshot, Consultant; Bigfoot Biomedical, Inc., Insulet Corporation, Medtronic, Lilly, Research Support; Insulet Corporation, Medtronic, NIH - National Institutes of Health, Juvenile Diabetes Research Foundation (JDRF), Speaker's Bureau; Insulet Corporation, Zealand Pharma A/S, Lilly, Medtronic. S.Bergford: None. S.R.Patton: None. M.A.Clements: Consultant; Glooko, Inc., Research Support; Dexcom, Inc., Abbott Diabetes. P.Calhoun: None. R.L.Gal: None. M.Riddell: Advisory Panel; Zealand Pharma A/S, Zucara Therapeutics, Indigo Diabetes, Consultant; Lilly Diabetes, Eli Lilly and Company, Jaeb Center for Health Research, Speaker's Bureau; Dexcom, Inc., Novo Nordisk, Sanofi, Stock/Shareholder; Supersapiens, Zucara Therapeutics. T1dexip study group: n/a. Funding The Leona M. and Harry B. Helmsley Charitable Trust; Dexcom, Inc.
    Type of Medium: Online Resource
    ISSN: 0012-1797
    URL: Article
    DOI: 10.2337/db23-575-P
    Language: English
    Publisher: American Diabetes Association
    Publication Date: 2023
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  • 6
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    336-OR: Insulin Delivery Modality Does Not Impact Glycemic Change during Physical Activity in Youth with Type 1 Diabetes (T1D)—Results from the Real-World T1DEXI Pediatric Study
    American Diabetes Association ; 2023
    In:  Diabetes Vol. 72, No. Supplement_1 ( 2023-06-20)
    Details
    In: Diabetes, American Diabetes Association, Vol. 72, No. Supplement_1 ( 2023-06-20)
    Abstract: Despite its well-established benefits, exercise can cause blood glucose levels to drop precipitously. Factors such as pre-exercise glucose, exercise type and insulin on board (IOB) all appear to influence the magnitude of drop in glucose during exercise, but it is currently unclear if insulin delivery modality (i.e., MDI vs. standard pump vs. closed loop pump) has a clinically significant effect. Data from the Type 1 Diabetes Exercise Initiative Pediatric (T1DEXIP) study allowed us to examine if insulin delivery modality influences the change in glucose during exercise in youth with T1D. Youth (N=248) with T1D ([mean ± SD] age= 14±2 years; T1D duration= 5.4±3.9 years; HbA1c= 7.1±1.3%; BMI percentile= 62±27%; 58% male) wore a continuous glucose monitor (Dexcom G6) and a Garmin, Vivosmart 4 activity monitor while logging meals and activity with the bant smartphone app over a 10-day period. Drop in glucose level during exercise was associated with pre-exercise glucose and IOB (mean change in glucose of 5.7 mg/dL, -15.7 mg/dL, and -26.5 mg/dL for IOB of 0 U/kg, & gt;0 to & lt;0.1 U/kg, and ≥0.1 U/kg, respectively; p & lt;0.001), but did not differ significantly by insulin delivery modality (Figure). Pre-exercise glucose and IOB, but not insulin delivery method, are associated with changes in glucose during exercise in youth with T1D. Disclosure M.Riddell: Advisory Panel; Zealand Pharma A/S, Zucara Therapeutics, Indigo Diabetes, Consultant; Lilly Diabetes, Eli Lilly and Company, Jaeb Center for Health Research, Speaker's Bureau; Dexcom, Inc., Novo Nordisk, Sanofi, Stock/Shareholder; Supersapiens, Zucara Therapeutics. S.Bergford: None. R.L.Gal: None. S.R.Patton: None. M.A.Clements: Consultant; Glooko, Inc., Research Support; Dexcom, Inc., Abbott Diabetes. P.Calhoun: None. J.Sherr: Advisory Panel; Bigfoot Biomedical, Inc., Insulet Corporation, Medtronic, Vertex Pharmaceuticals Incorporated, Cecelia Health, StartUp Health T1D Moonshot, Consultant; Bigfoot Biomedical, Inc., Insulet Corporation, Medtronic, Lilly, Research Support; Insulet Corporation, Medtronic, NIH - National Institutes of Health, Juvenile Diabetes Research Foundation (JDRF), Speaker's Bureau; Insulet Corporation, Zealand Pharma A/S, Lilly, Medtronic. T1dexip study group: n/a. Funding The Leona M. and Harry B. Helmsley Charitable Trust; Dexcom, Inc.
    Type of Medium: Online Resource
    ISSN: 0012-1797
    URL: Article
    DOI: 10.2337/db23-336-OR
    Language: English
    Publisher: American Diabetes Association
    Publication Date: 2023
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  • 7
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    The Type 1 Diabetes and EXercise Initiative: Predicting Hypoglycemia Risk During Exercise for Participants with Type 1 Diabetes Using Repeated Measures Random Forest
    Mary Ann Liebert Inc ; 2023
    In:  Diabetes Technology & Therapeutics Vol. 25, No. 9 ( 2023-09-01), p. 602-611
    Details
    In: Diabetes Technology & Therapeutics, Mary Ann Liebert Inc, Vol. 25, No. 9 ( 2023-09-01), p. 602-611
    Type of Medium: Online Resource
    ISSN: 1520-9156 , 1557-8593
    URL: Article
    DOI: 10.1089/dia.2023.0140
    Language: English
    Publisher: Mary Ann Liebert Inc
    Publication Date: 2023
    detail.hit.zdb_id: 2004914-6
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  • 8
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    A Comparison of Faster Insulin Aspart with Standard Insulin Aspart Using Hybrid Automated Insulin Delivery System in Active Children and Adolescents with Type 1 Diabetes: A Randomized Double-Blind Crossover Trial
    Mary Ann Liebert Inc ; 2023
    In:  Diabetes Technology & Therapeutics Vol. 25, No. 9 ( 2023-09-01), p. 612-621
    Details
    In: Diabetes Technology & Therapeutics, Mary Ann Liebert Inc, Vol. 25, No. 9 ( 2023-09-01), p. 612-621
    Type of Medium: Online Resource
    ISSN: 1520-9156 , 1557-8593
    URL: Article
    DOI: 10.1089/dia.2023.0178
    Language: English
    Publisher: Mary Ann Liebert Inc
    Publication Date: 2023
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