Randomized Controlled Trial of Mobile Closed-Loop Control.
Diabetes Care
; 43(3): 607-615, 2020 03.
Article
in En
| MEDLINE
| ID: mdl-31937608
ABSTRACT
OBJECTIVE:
Assess the efficacy of inControl AP, a mobile closed-loop control (CLC) system. RESEARCH DESIGN ANDMETHODS:
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 coprimaryoutcomes:
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 11 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.
Full text:
1
Database:
MEDLINE
Main subject:
Blood Glucose
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Insulin Infusion Systems
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Biosensing Techniques
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Telemedicine
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Diabetes Mellitus, Type 1
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Insulin
Type of study:
Clinical_trials
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Guideline
Limits:
Adolescent
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Adult
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Aged
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Female
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Humans
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Male
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Middle aged
Country/Region as subject:
America do norte
Language:
En
Year:
2020
Type:
Article