Safety and Efficacy of Initializing the Control-IQ Artificial Pancreas System Based on Total Daily Insulin in Adolescents with Type 1 Diabetes
Objective: To assess the safety and efficacy of a simplified initialization for the Tandem t:slim X2 Control-IQ hybrid closed-loop system, using parameters based on total daily insulin ("MyTDI") in adolescents with type 1 diabetes under usual activity and during periods of increased exercise. Research Design and Methods: Adolescents with type 1 diabetes 12-18 years of age used Control-IQ for 5 days at home using their usual parameters. Upon arrival at a 60-h ski camp, participants were randomized to either continue Control-IQ using their home settings or to reinitialize Control-IQ with MyTDI parameters. Control-IQ use continued for 5 days following camp. The effect of MyTDI on continuous glucose monitoring outcomes were analyzed using repeated measures analysis of variance (ANOVA): baseline, camp, and at home. Results: Twenty participants were enrolled and completed the study; two participants were excluded from the analysis due to absence from ski camp (1) and illness (1). Time in range was similar between both groups at home and camp. A tendency to higher time <70 mg/dL in the MyTDI group was present but only during camp (median 3.8% vs. 1.4%, P = 0.057). MyTDI users with bolus/TDI ratios >40% tended to show greater time in the euglycemic range improvements between baseline and home than users with ratios <40% (+16.3% vs. -9.0%, P = 0.012). All participants maintained an average of 95% time in closed loop (84.1%-100%). Conclusions: MyTDI is a safe, effective, and easy way to determine insulin parameters for use in the Control-IQ artificial pancreas. Future modifications to account for the influence of carbohydrate intake on MyTDI calculations might further improve time in range.
| Medienart: |
E-Artikel |
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| Erscheinungsjahr: |
2020 |
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| Erschienen: |
2020 |
| Enthalten in: |
Zur Gesamtaufnahme - volume:22 |
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| Enthalten in: |
Diabetes technology & therapeutics - 22(2020), 8 vom: 31. Aug., Seite 594-601 |
| Sprache: |
Englisch |
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| Beteiligte Personen: |
Schoelwer, Melissa J [VerfasserIn] |
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| Links: |
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| Anmerkungen: |
Date Completed 14.10.2021 Date Revised 14.10.2021 published: Print-Electronic Citation Status MEDLINE |
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| doi: |
10.1089/dia.2019.0471 |
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| funding: |
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| Förderinstitution / Projekttitel: |
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| PPN (Katalog-ID): |
NLM30711595X |
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| 100 | 1 | |a Schoelwer, Melissa J |e verfasserin |4 aut | |
| 245 | 1 | 0 | |a Safety and Efficacy of Initializing the Control-IQ Artificial Pancreas System Based on Total Daily Insulin in Adolescents with Type 1 Diabetes |
| 264 | 1 | |c 2020 | |
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| 500 | |a Date Completed 14.10.2021 | ||
| 500 | |a Date Revised 14.10.2021 | ||
| 500 | |a published: Print-Electronic | ||
| 500 | |a Citation Status MEDLINE | ||
| 520 | |a Objective: To assess the safety and efficacy of a simplified initialization for the Tandem t:slim X2 Control-IQ hybrid closed-loop system, using parameters based on total daily insulin ("MyTDI") in adolescents with type 1 diabetes under usual activity and during periods of increased exercise. Research Design and Methods: Adolescents with type 1 diabetes 12-18 years of age used Control-IQ for 5 days at home using their usual parameters. Upon arrival at a 60-h ski camp, participants were randomized to either continue Control-IQ using their home settings or to reinitialize Control-IQ with MyTDI parameters. Control-IQ use continued for 5 days following camp. The effect of MyTDI on continuous glucose monitoring outcomes were analyzed using repeated measures analysis of variance (ANOVA): baseline, camp, and at home. Results: Twenty participants were enrolled and completed the study; two participants were excluded from the analysis due to absence from ski camp (1) and illness (1). Time in range was similar between both groups at home and camp. A tendency to higher time <70 mg/dL in the MyTDI group was present but only during camp (median 3.8% vs. 1.4%, P = 0.057). MyTDI users with bolus/TDI ratios >40% tended to show greater time in the euglycemic range improvements between baseline and home than users with ratios <40% (+16.3% vs. -9.0%, P = 0.012). All participants maintained an average of 95% time in closed loop (84.1%-100%). Conclusions: MyTDI is a safe, effective, and easy way to determine insulin parameters for use in the Control-IQ artificial pancreas. Future modifications to account for the influence of carbohydrate intake on MyTDI calculations might further improve time in range | ||
| 650 | 4 | |a Journal Article | |
| 650 | 4 | |a Randomized Controlled Trial | |
| 650 | 4 | |a Research Support, Non-U.S. Gov't | |
| 650 | 4 | |a AID initialization | |
| 650 | 4 | |a Artificial pancreas | |
| 650 | 4 | |a Automated insulin delivery | |
| 650 | 4 | |a Clinical trials | |
| 650 | 4 | |a Closed-loop systems | |
| 650 | 4 | |a Continuous glucose monitoring | |
| 650 | 4 | |a Exercise | |
| 650 | 7 | |a Blood Glucose |2 NLM | |
| 650 | 7 | |a Hypoglycemic Agents |2 NLM | |
| 650 | 7 | |a Insulin |2 NLM | |
| 700 | 1 | |a Robic, Jessica L |e verfasserin |4 aut | |
| 700 | 1 | |a Gautier, Thibault |e verfasserin |4 aut | |
| 700 | 1 | |a Fabris, Chiara |e verfasserin |4 aut | |
| 700 | 1 | |a Carr, Kelly |e verfasserin |4 aut | |
| 700 | 1 | |a Clancy-Oliveri, Mary |e verfasserin |4 aut | |
| 700 | 1 | |a Brown, Sue A |e verfasserin |4 aut | |
| 700 | 1 | |a Anderson, Stacey M |e verfasserin |4 aut | |
| 700 | 1 | |a DeBoer, Mark D |e verfasserin |4 aut | |
| 700 | 1 | |a Cherñavvsky, Daniel R |e verfasserin |4 aut | |
| 700 | 1 | |a Breton, Marc D |e verfasserin |4 aut | |
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