Exercise and Diabetes - an Observational Study of Exercise and Blood Glucose Control

Completed

• Conditions: Type 1 Diabetes; Type 2 Diabetes
• Interventions: Other: exercise

• Registration Number: NCT02190669
• Lead Sponsor: Sansum Diabetes Research Institute

Brief Summary

This proposal seeks to gather continuous blood glucose and physical activity data from individuals with and without diabetes.

Detailed Description

This proposal seeks to gather continuous blood glucose and physical activity data from individuals with and without diabetes who are physically active and exercising for health benefits. The investigators hypothesize that insulin requirements will be inversely related to intensity of activity and an algorithm will be able to detect physical activity and automatically adjust insulin doses. Once such an algorithm has been determined for an individual, it can be applied to future similar situations, but ideally the algorithm will be dynamically refined based on closed-loop feedback information.

Study Timeline

• Study Start: 2014-06
• Primary Completion: 2014-07
• Study Completion: 2014-07
• Study First Submitted: 2014-07-11
• Study First Submitted QC: 2014-07-14
• Study First Posted: 2014-07-15
• Status Verified: 2014-11
• Last Update Submitted: 2014-11-12
• Last Update Posted: 2014-11-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

Inclusion Criteria

• Inclusion criteria for subjects with diabetes
• Type 1 diabetes or insulin requiring type 2 diabetes for at least 1 year
• Use insulin to control diabetes
• Physically active (regularly work out, swim, run, walk, bike, etc.)
• Free of major micro- and macrovascular complications of diabetes
• 18-75 years of age
• A1C < 9.0% Inclusion criteria for subjects without diabetes
• No evidence of diabetes and physically active

Exclusion Criteria

• unwilling to perform repeated glucose checks or take insulin as instructed
• abnormal thyroid function, kidney function, liver function
• pregnancy

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
exercise in individuals without diabetes	exercise	exercise in individuals without diabetes
exercise in type 1 diabetes	exercise	exercise in type 1 diabetes
exercise in type 2 diabetes	exercise	exercise in type 2 diabetes

Primary Outcome Measures

Name	Time	Method
Document the glycemic response of individuals without diabetes and with type 1 or type 2 diabetes	7 days

Trial Locations

Locations (1)

Sansum Diabetes Research Institute; 🇺🇸 Santa Barbara, California, United States