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Randomized Controlled Trial
. 2020 Mar;43(3):607-615.
doi: 10.2337/dc19-1310. Epub 2020 Jan 14.

Randomized Controlled Trial of Mobile Closed-Loop Control

Boris Kovatchev  1 , Stacey M Anderson  2 , Dan Raghinaru  3 , Yogish C Kudva  4 , Lori M Laffel  5 , Carol Levy  6 , Jordan E Pinsker  7 , R Paul Wadwa  8 , Bruce Buckingham  9 , Francis J Doyle 3rd  10 , Sue A Brown  2 , Mei Mei Church  7 , Vikash Dadlani  4 , Eyal Dassau  10 , Laya Ekhlaspour  9 , Gregory P Forlenza  8 , Elvira Isganaitis  5 , David W Lam  6 , John Lum  11 , Roy W Beck; iDCL Study Group
Collaborators, Affiliations
Randomized Controlled Trial

Randomized Controlled Trial of Mobile Closed-Loop Control

Boris Kovatchev et al. Diabetes Care. 2020 Mar.

Erratum in

  • Erratum. Randomized Controlled Trial of Mobile Closed-Loop Control. Diabetes Care 2020;43:607-615.
    Kovatchev B, Anderson SM, Raghinaru D, Kudva YC, Laffel LM, Levy C, Pinsker JE, Wadwa RP, Buckingham B, Doyle FJ 3rd, Brown SA, Church MM, Dadlani V, Dassau E, Ekhlaspour L, Forlenza GP, Isganaitis E, Lam DW, Lum J, Beck RW; iDCL Study Group. Kovatchev B, et al. Diabetes Care. 2020 Jun;43(6):1366. doi: 10.2337/dc20-er06. Epub 2020 Apr 3. Diabetes Care. 2020. PMID: 32245747 Free PMC article. No abstract available.

Abstract

Objective: Assess the efficacy of inControl AP, a mobile closed-loop control (CLC) system.

Research design and methods: This protocol, NCT02985866, is a 3-month parallel-group, multicenter, randomized unblinded trial designed to compare mobile CLC with sensor-augmented pump (SAP) therapy. Eligibility criteria were type 1 diabetes for at least 1 year, use of insulin pumps for at least 6 months, age ≥14 years, and baseline HbA1c <10.5% (91 mmol/mol). The study was designed to assess two coprimary outcomes: superiority of CLC over SAP in continuous glucose monitor (CGM)-measured time below 3.9 mmol/L and noninferiority in CGM-measured time above 10 mmol/L.

Results: Between November 2017 and May 2018, 127 participants were randomly assigned 1:1 to CLC (n = 65) versus SAP (n = 62); 125 participants completed the study. CGM time below 3.9 mmol/L was 5.0% at baseline and 2.4% during follow-up in the CLC group vs. 4.7% and 4.0%, respectively, in the SAP group (mean difference -1.7% [95% CI -2.4, -1.0]; P < 0.0001 for superiority). CGM time above 10 mmol/L was 40% at baseline and 34% during follow-up in the CLC group vs. 43% and 39%, respectively, in the SAP group (mean difference -3.0% [95% CI -6.1, 0.1]; P < 0.0001 for noninferiority). One severe hypoglycemic event occurred in the CLC group, which was unrelated to the study device.

Conclusions: In meeting its coprimary end points, superiority of CLC over SAP in CGM-measured time below 3.9 mmol/L and noninferiority in CGM-measured time above 10 mmol/L, the study has demonstrated that mobile CLC is feasible and could offer certain usability advantages over embedded systems, provided the connectivity between system components is stable.

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Figures

Figure 1
Figure 1
Postrandomization hourly proportion of time when sensor glucose was below 70 mg/dL (A) and above 180 mg/dL (B).
Figure 2
Figure 2
Postrandomization hourly mean sensor glucose (A) and proportion of time when sensor glucose was between 70 and 180 mg/dL (B).
See this image and copyright information in PMC

References

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