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  • 1
    In: Diabetes, American Diabetes Association, Vol. 68, No. Supplement_1 ( 2019-06-01)
    Abstract: Background: The Medtronic 670G Hybrid Closed Loop (HCL) is completing pivotal trials in children with type 1 diabetes & lt;7 years old. Little is known about how to support families and young children using HCL. Methods: Participants ages 2-7 in the 670G pivotal trial extension phase participated in novel, ongoing, multicenter videoconferencing interventions to support HCL use. Families downloaded HCL every 2 weeks and were randomized to two support interventions or a minimum feedback (control arm) targeted to either failed adherence ( & lt;80% Auto Mode) or suboptimal glycemic control (time 70-180 mg/dl & lt;70%) by Sequential Multiple Assignment Randomization Trial (SMART) design. Interventions included two audio/videoconferencing sessions in a 2-week period. Participants were evaluated and re-randomized every 2 weeks over 3 months. Paired t-tests were used to compare glycemic and quality-of-life outcomes. Results: Child-parent dyads (n=23) were enrolled (mean child age 5.2 ± 1.5 years, 39% female, mean diabetes duration 34 months). Dyads received a total of 39 interventions. HbA1c, Time-in-Range, and Auto Mode use remained stable over 3 months, and diabetes distress and hypoglycemia fear and confidence improved significantly (Table). Data collection is ongoing. Conclusion: Targeted interventions for caregivers of young children using HCL demonstrated quality-of-life improvements without deterioration in glycemic control or Auto Mode use. Disclosure L.H. Messer: Advisory Panel; Self; Capillary Biomedical, Inc. Consultant; Self; Clinical Sensors. S. Hanes: None. I. Tabatabai: None. L. DiMeglio: Research Support; Self; Amgen Inc., Caladrius Biosciences, Inc., Janssen Research & Development, Medtronic, Sanofi. Other Relationship; Self; Dexcom, Inc. T.S. Hannon: Advisory Panel; Self; Eli Lilly and Company. G.P. Forlenza: Advisory Panel; Self; Dexcom, Inc. Consultant; Self; Medtronic MiniMed, Inc., Tandem Diabetes Care. Research Support; Self; Dexcom, Inc., Insulet Corporation, Medtronic MiniMed, Inc., Tandem Diabetes Care. S. Woerner: None. S. Lange: Other Relationship; Self; Medtronic MiniMed, Inc. K.A. Driscoll: None. K.K. Hood: Consultant; Self; Lilly Diabetes. Research Support; Self; Dexcom, Inc. Speaker's Bureau; Self; Johnson & Johnson Diabetes Institute. H. Rodriguez: Research Support; Self; Boehringer Ingelheim Pharmaceuticals, Inc., Bristol-Myers Squibb Company, Daiichi Pharm Corp, MannKind Corporation, Medtronic MiniMed, Inc. Research Support; Spouse/Partner; Medtronic MiniMed, Inc. Research Support; Self; Takeda Pharmaceutical Company Limited. Other Relationship; Self; Merck & Co., Inc., Novartis Pharmaceuticals Corporation, Novo Nordisk Inc. 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. Funding National Institute of Diabetes and Digestive and Kidney Diseases
    Type of Medium: Online Resource
    ISSN: 0012-1797 , 1939-327X
    Language: English
    Publisher: American Diabetes Association
    Publication Date: 2019
    detail.hit.zdb_id: 1501252-9
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  • 2
    In: Diabetes Care, American Diabetes Association, Vol. 43, No. 8 ( 2020-08-01), p. 1822-1828
    Abstract: Limited information is available about glycemic outcomes with a closed-loop control (CLC) system compared with a predictive low-glucose suspend (PLGS) system. RESEARCH DESIGN AND METHODS After 6 months of use of a CLC system in a randomized trial, 109 participants with type 1 diabetes (age range, 14–72 years; mean HbA1c, 7.1% [54 mmol/mol]) were randomly assigned to CLC (N = 54, Control-IQ) or PLGS (N = 55, Basal-IQ) groups for 3 months. The primary outcome was continuous glucose monitor (CGM)-measured time in range (TIR) for 70–180 mg/dL. Baseline CGM metrics were computed from the last 3 months of the preceding study. RESULTS All 109 participants completed the study. Mean ± SD TIR was 71.1 ± 11.2% at baseline and 67.6 ± 12.6% using intention-to-treat analysis (69.1 ± 12.2% using per-protocol analysis excluding periods of study-wide suspension of device use) over 13 weeks on CLC vs. 70.0 ± 13.6% and 60.4 ± 17.1% on PLGS (difference = 5.9%; 95% CI 3.6%, 8.3%; P & lt; 0.001). Time & gt;180 mg/dL was lower in the CLC group than PLGS group (difference = −6.0%; 95% CI −8.4%, −3.7%; P & lt; 0.001) while time & lt;54 mg/dL was similar (0.04%; 95% CI −0.05%, 0.13%; P = 0.41). HbA1c after 13 weeks was lower on CLC than PLGS (7.2% [55 mmol/mol] vs. 7.5% [56 mmol/mol] , difference −0.34% [−3.7 mmol/mol]; 95% CI −0.57% [−6.2 mmol/mol] , −0.11% [1.2 mmol/mol]; P = 0.0035). CONCLUSIONS Following 6 months of CLC, switching to PLGS reduced TIR and increased HbA1c toward their pre-CLC values, while hypoglycemia remained similarly reduced with both CLC and PLGS.
    Type of Medium: Online Resource
    ISSN: 0149-5992 , 1935-5548
    Language: English
    Publisher: American Diabetes Association
    Publication Date: 2020
    detail.hit.zdb_id: 1490520-6
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  • 3
    Online Resource
    Online Resource
    American Diabetes Association ; 1986
    In:  Diabetes Vol. 35, No. 4 ( 1986-04-01), p. 448-453
    In: Diabetes, American Diabetes Association, Vol. 35, No. 4 ( 1986-04-01), p. 448-453
    Type of Medium: Online Resource
    ISSN: 0012-1797 , 0012-1797
    Language: English
    Publisher: American Diabetes Association
    Publication Date: 1986
    detail.hit.zdb_id: 1501252-9
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  • 4
    Online Resource
    Online Resource
    American Diabetes Association ; 2019
    In:  Diabetes Vol. 68, No. Supplement_1 ( 2019-06-01)
    In: Diabetes, American Diabetes Association, Vol. 68, No. Supplement_1 ( 2019-06-01)
    Abstract: Objective: Formulas to determine Insulin-Carbohydrate Ratio (ICR) use total daily dose (TDD) such as the 450 Rule (450/TDD=ICR) or body weight (BW) (2.8*weight in pounds/TDD). These do not account for age differences or adjust for HCL therapy. Methods: We analyzed data from Medtronic 670G users meeting the following criteria: Time in Range (TIR, 70-180mg/dl) & gt;65%, Time & lt;70mg/dl & lt;5%, A1c & lt;8%, HCL for & gt;3 months. Subjects were grouped by age: pre-pubertal, pubertal, and adult (18+). Subjects’ current ICR was multiplied by TDD at each meal to determine a formula starting point. Results: 50 subjects were included (age 6-62, mean A1c 7.2%, TDD 0.8 u/kg/day, TIR 75%, 2.5% & lt;70mg/dl). Compared to baseline, ICRs in HCL were made 10-26% more aggressive. ICRs calculated from the 450 rule were 15-41% less aggressive compared to the ratios used by HCL subjects. BW formula ICRs were too aggressive for pre-pubertal, closely matched the pubertal subjects, and underestimated meal bolus needs in adults on HCL. Conclusions: Our data offers new initial ICR formulas for HCL users instead of the 450/TDD rule, i.e., a 300/TDD for adults and a 350/TDD for pubertal and prepubertal children at lunch/dinner, and a breakfast 300/TDD rule. Fine-tuning is necessary for each patient, but this offers a better tuned starting point for subjects starting HCL, helping minimize HCL exits due to post-prandial hyperglycemia. Disclosure I. Tabatabai: None. 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.
    Type of Medium: Online Resource
    ISSN: 0012-1797 , 1939-327X
    Language: English
    Publisher: American Diabetes Association
    Publication Date: 2019
    detail.hit.zdb_id: 1501252-9
    Location Call Number Limitation Availability
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  • 5
    In: Diabetes Care, American Diabetes Association, Vol. 43, No. 1 ( 2020-01-01), p. e1-e2
    Type of Medium: Online Resource
    ISSN: 0149-5992 , 1935-5548
    Language: English
    Publisher: American Diabetes Association
    Publication Date: 2020
    detail.hit.zdb_id: 1490520-6
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