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

Type 2 Diabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02190669
• Other study ID #: 08-67
• Status: Completed
• Phase: N/A
• First received: July 11, 2014
• Last updated: November 12, 2014
• Start date: June 2014
• Est. completion date: July 2014

Study information

• Verified date: November 2014
• Source: William Sansum Diabetes Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: July 2014
• Est. primary completion date: July 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Diabetes Mellitus
• Type 1 Diabetes
• Type 2 Diabetes

Intervention

Other:
• exercise
Sprinting, walking on a treadmill, and stationary bicycle riding

Locations

Country	Name	City	State
United States	Sansum Diabetes Research Institute	Santa Barbara	California

Sponsors (1)

Lead Sponsor	Collaborator
William Sansum Diabetes Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Document the glycemic response of individuals without diabetes and with type 1 or type 2 diabetes		7 days	No