Randomized Controlled Trial of Mobile Closed-Loop Control.

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 HbA_1c <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 =

SUBMITTER: Kovatchev B 

PROVIDER: S-EPMC7035585 | biostudies-literature | 2020 Mar

REPOSITORIES: biostudies-literature