TY - JOUR
T1 - Outcomes in Pump- and CGM-Baseline Use Subgroups in the International Diabetes Closed-Loop Trial
AU - Ekhlaspour, Laya
AU - Raghinaru, Dan
AU - Forlenza, Gregory P.
AU - Isganaitis, Elvira
AU - Kudva, Yogish C.
AU - Lam, David W.
AU - Levister, Camilla
AU - O’Malley, Grenye
AU - Church, Mei Mei
AU - Lum, John W.
AU - Buckingham, Bruce
AU - Brown, Sue A.
N1 - Funding Information:
The author(s) disclosed receipt of the following financial support for the research, authorship, and/or publication of this article: This work was supported by NIDDK grant UC4 DK 108483, as well as material support from Tandem. We thank research participants and their families.
Funding Information:
The author(s) declared the following potential conflicts of interest with respect to the research, authorship, and/or publication of this article: LE has received consulting fees from Tandem Diabetes and Ypsomed. DR reports receiving grant support and supplies, paid to his institution from Tandem Diabetes. GPF reports receiving grant support and lecture fees from Medtronic MiniMed and Insulet, grant support from Abbott, grant support and consulting fees from Lilly, and grant support and lecture fees from Dexcom. YCK has received product support from Dexcom Inc, Roche Diabetes, and Tandem Diabetes. DWL has no disclosures to report. CL has no disclosures to report. GO receives research support from Tandem Diabetes, Insulet, Dexcom, and Abbott. MMC has no disclosures to report. JWL reports receiving consulting fees, paid to his institution, from Animas Corporation, Bigfoot Biomedical, Tandem Diabetes Care, and Eli Lilly and Company. BB has received research support from Medtronic, Insulet, Tandem, Dexcom, and Convatec. SAB has received research support from Tandem Diabetes Care, Insulet, Dexcom, Roche, and Tolerion.
Publisher Copyright:
© 2022 Diabetes Technology Society.
PY - 2023/7
Y1 - 2023/7
N2 - Background: We investigated the potential benefits of automated insulin delivery (AID) among individuals with type 1 diabetes (T1D) in sub-populations of baseline device use determined by continuous glucose monitor (CGM) use status and insulin delivery via multiple daily injections (MDI) or insulin pump. Materials and Methods: In a six-month randomized, multicenter trial, 168 individuals were assigned to closed-loop control (CLC, Control-IQ, Tandem Diabetes Care), or sensor-augmented pump (SAP) therapy. The trial included a two- to eight-week run-in phase to train participants on study devices. The participants were stratified into four subgroups: insulin pump and CGM (pump+CGM), pump-only, MDI and CGM (MDI+CGM), and MDI users without CGM (MDI-only) users. We compared glycemic outcomes among four subgroups. Results: At baseline, 61% were pump+CGM users, 18% pump-only users, 10% MDI+CGM users, and 11% MDI-only users. Mean time in range 70-180 mg/dL (TIR) improved from baseline in the four subgroups using CLC: pump+CGM, 62% to 73%; pump-only, 61% to 70%; MDI+CGM, 54% to 68%; and MDI-only, 61% to 69%. The reduction in time below 70 mg/dL from baseline was comparable among the four subgroups. No interaction effect was detected with baseline device use for TIR (P =.67) or time below (P =.77). On the System Usability Questionnaire, scores were high at 26 weeks for all subgroups: pump+CGM: 87.2 ± 12.1, pump-only: 89.4 ± 8.2, MDI+CGM 87.2 ± 9.3, MDI: 78.1 ± 15. Conclusions: There was a consistent benefit in patients with T1D when using CLC, regardless of baseline insulin delivery modality or CGM use. These data suggest that this CLC system can be considered across a wide range of patients.
AB - Background: We investigated the potential benefits of automated insulin delivery (AID) among individuals with type 1 diabetes (T1D) in sub-populations of baseline device use determined by continuous glucose monitor (CGM) use status and insulin delivery via multiple daily injections (MDI) or insulin pump. Materials and Methods: In a six-month randomized, multicenter trial, 168 individuals were assigned to closed-loop control (CLC, Control-IQ, Tandem Diabetes Care), or sensor-augmented pump (SAP) therapy. The trial included a two- to eight-week run-in phase to train participants on study devices. The participants were stratified into four subgroups: insulin pump and CGM (pump+CGM), pump-only, MDI and CGM (MDI+CGM), and MDI users without CGM (MDI-only) users. We compared glycemic outcomes among four subgroups. Results: At baseline, 61% were pump+CGM users, 18% pump-only users, 10% MDI+CGM users, and 11% MDI-only users. Mean time in range 70-180 mg/dL (TIR) improved from baseline in the four subgroups using CLC: pump+CGM, 62% to 73%; pump-only, 61% to 70%; MDI+CGM, 54% to 68%; and MDI-only, 61% to 69%. The reduction in time below 70 mg/dL from baseline was comparable among the four subgroups. No interaction effect was detected with baseline device use for TIR (P =.67) or time below (P =.77). On the System Usability Questionnaire, scores were high at 26 weeks for all subgroups: pump+CGM: 87.2 ± 12.1, pump-only: 89.4 ± 8.2, MDI+CGM 87.2 ± 9.3, MDI: 78.1 ± 15. Conclusions: There was a consistent benefit in patients with T1D when using CLC, regardless of baseline insulin delivery modality or CGM use. These data suggest that this CLC system can be considered across a wide range of patients.
KW - closed-loop control
KW - continuous glucose monitoring
KW - efficacy
KW - insulin pump
KW - multiple daily injection
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U2 - 10.1177/19322968221089361
DO - 10.1177/19322968221089361
M3 - Article
C2 - 35473359
AN - SCOPUS:85129880240
SN - 1932-2968
VL - 17
SP - 935
EP - 942
JO - Journal of Diabetes Science and Technology
JF - Journal of Diabetes Science and Technology
IS - 4
ER -