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

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by Sansum Diabetes Research Institute
Sponsor:
Information provided by (Responsible Party):
Sansum Diabetes Research Institute
ClinicalTrials.gov Identifier:
NCT02190669
First received: July 11, 2014
Last updated: July 14, 2014
Last verified: June 2014
  Purpose

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.


Condition Intervention
Type 1 Diabetes
Type 2 Diabetes
Other: exercise

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective

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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 12
Study Start Date: June 2014
Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
individuals without diabetes
individuals without diabetes
Other: exercise
individuals with type 1 diabetes
individuals with type 1 diabetes
Other: exercise
individuals with type 2 diabetes
individuals with type 2 diabetes
Other: exercise

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02190669

Locations
United States, California
Sansum Diabetes Research Institute Recruiting
Santa Barbara, California, United States, 93105
Contact: Wendy Bevier, Ph.D.    805-682-7640 ext 207    wbevier@sansum.org   
Principal Investigator: Kristin Castorino, DO         
Sponsors and Collaborators
Sansum Diabetes Research Institute
  More Information

No publications provided

Responsible Party: Sansum Diabetes Research Institute
ClinicalTrials.gov Identifier: NCT02190669     History of Changes
Other Study ID Numbers: 08-67
Study First Received: July 11, 2014
Last Updated: July 14, 2014
Health Authority: Institutional review board United States:

Additional relevant MeSH terms:
Diabetes Mellitus, Type 2
Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on September 18, 2014