NCT03443713

Evaluation of Physician-based Decision Support

Evaluation of Physician-based Decision Support in Patients With Type 1 Diabetes on Multiple Daily Injection Therapy

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 25 (actual)
• Sponsor: Oregon Health and Science University · Academic / Other
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Not accepted

Summary

The goal of this study is to assess the impact of physician-driven insulin setting changes in type 1 patients using multiple daily injection insulin therapy with exercise. This is a short outpatient study with multiple outpatient and home exercise sessions with an assigned type of exercise.

Detailed description

Subjects will be on study for 28 days. Sensor glucose, exercise, insulin and meal data will be collected during this time. Subjects will wear the Dexcom G6 CGM system and a physical activity monitor. The Subjects will complete 2 exercise visits in-clinic and 4 exercise visits as an outpatient. Subjects will be randomized to aerobic, anaerobic or high intensity interval exercise sessions for 30 minutes each. Physicians will review CGM and insulin data every 7 days and make insulin dose recommendations that the subject will adjust in the dose calculator.

Conditions

• Type 1 Diabetes Mellitus
• MDI
• CGM
• Exercise

Interventions

Type	Name	Description
DEVICE	Dexcom G6 CGM	Subjects will wear a Dexcom G6 CGM for the 28 days they are on study.

Timeline

• Start date: 2018-07-18
• Primary completion: 2019-05-08
• Completion: 2019-05-08
• First posted: 2018-02-23
• Last updated: 2020-03-18
• Results posted: 2020-03-18

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study