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

November 12, 2014 updated by: Sansum Diabetes Research Institute
This proposal seeks to gather continuous blood glucose and physical activity data from individuals with and without diabetes.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

12

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Santa Barbara, California, United States, 93105
        • Sansum Diabetes Research Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

individuals without diabetes and those with type 1 and type 2 diabetes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
exercise in individuals without diabetes
Other: exercise
Sprinting, walking on a treadmill, and stationary bicycle riding
exercise in type 1 diabetes
Other: exercise
Sprinting, walking on a treadmill, and stationary bicycle riding
exercise in type 2 diabetes
Other: exercise
Sprinting, walking on a treadmill, and stationary bicycle riding

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Document the glycemic response of individuals without diabetes and with type 1 or type 2 diabetes
Time Frame: 7 days
7 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sansum Diabetes Research Institute

Investigators

  • Principal Investigator: Kristin Castorino, D.O., Sansum Diabetes Research Institute

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2014

Primary Completion (Actual)

July 1, 2014

Study Completion (Actual)

July 1, 2014

Study Registration Dates

First Submitted

July 11, 2014

First Submitted That Met QC Criteria

July 14, 2014

First Posted (Estimate)

July 15, 2014

Study Record Updates

Last Update Posted (Estimate)

November 13, 2014

Last Update Submitted That Met QC Criteria

November 12, 2014

Last Verified

November 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 08-67

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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