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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02190669
First Posted: July 15, 2014
Last Update Posted: November 13, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Sansum Diabetes Research Institute
  Purpose
This proposal seeks to gather continuous blood glucose and physical activity data from individuals with and without diabetes.

Condition Intervention
Type 1 Diabetes Type 2 Diabetes Other: exercise

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Exercise and Diabetes - an Observational Study of Exercise and Blood Glucose Control

Resource links provided by NLM:


Further study details as provided by Sansum Diabetes Research Institute:

Primary Outcome Measures:
  • Document the glycemic response of individuals without diabetes and with type 1 or type 2 diabetes [ Time Frame: 7 days ]

Enrollment: 12
Study Start Date: June 2014
Study Completion Date: July 2014
Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
exercise in individuals without diabetes
exercise in individuals without diabetes
Other: exercise
Sprinting, walking on a treadmill, and stationary bicycle riding
exercise in type 1 diabetes
exercise in type 1 diabetes
Other: exercise
Sprinting, walking on a treadmill, and stationary bicycle riding
exercise in type 2 diabetes
exercise in type 2 diabetes
Other: exercise
Sprinting, walking on a treadmill, and stationary bicycle riding

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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
individuals without diabetes and those with type 1 and type 2 diabetes
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02190669


Locations
United States, California
Sansum Diabetes Research Institute
Santa Barbara, California, United States, 93105
Sponsors and Collaborators
Sansum Diabetes Research Institute
Investigators
Principal Investigator: Kristin Castorino, D.O. Sansum Diabetes Research Institute
  More Information

Responsible Party: Sansum Diabetes Research Institute
ClinicalTrials.gov Identifier: NCT02190669     History of Changes
Other Study ID Numbers: 08-67
First Submitted: July 11, 2014
First Posted: July 15, 2014
Last Update Posted: November 13, 2014
Last Verified: November 2014

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases