Feasibility Studies of an Insulin-Only Bionic Pancreas in a Home-Use Setting.

ABSTRACT:

Background

We tested the safety and performance of the "insulin-only" configuration of the bionic pancreas (BP) closed-loop blood-glucose control system in a home-use setting to assess glycemic outcomes using different static and dynamic glucose set-points.

Method

This is an open-label non-randomized study with three consecutive intervention periods. Participants had consecutive weeks of usual care followed by the insulin-only BP with (1) an individualized static set-point of 115 or 130 mg/dL and (2) a dynamic set-point that automatically varied within 110 to 130 mg/dL, depending on hypoglycemic risk. Human factors (HF) testing was conducted using validated surveys. The last five days of each study arm were used for data analysis.

Results

Thirteen participants were en

SUBMITTER: Ekhlaspour L 

PROVIDER: S-EPMC6835195 | biostudies-literature | 2019 Nov

REPOSITORIES: biostudies-literature