NCT02190669

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jun 2014

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2014

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2014

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

July 11, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 15, 2014

Completed
Last Updated

November 13, 2014

Status Verified

November 1, 2014

Enrollment Period

1 month

First QC Date

July 11, 2014

Last Update Submit

November 12, 2014

Conditions

Type 1 DiabetesType 2 Diabetes

Outcome Measures

Primary Outcomes (1)

  • Document the glycemic response of individuals without diabetes and with type 1 or type 2 diabetes

    7 days

Study Arms (3)

exercise in individuals without diabetes

exercise in individuals without diabetes

Other: exercise

exercise in type 1 diabetes

exercise in type 1 diabetes

Other: exercise

exercise in type 2 diabetes

exercise in type 2 diabetes

Other: exercise

Interventions

exerciseOTHER

Sprinting, walking on a treadmill, and stationary bicycle riding

exercise in individuals without diabetesexercise in type 1 diabetesexercise in type 2 diabetes

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

  • 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
  • years of age
  • No evidence of diabetes and physically active

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sansum Diabetes Research Institute

Santa Barbara, California, 93105, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1Diabetes Mellitus, Type 2

Interventions

Exercise

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Kristin Castorino, D.O.

    Sansum Diabetes Research Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 11, 2014

First Posted

July 15, 2014

Study Start

June 1, 2014

Primary Completion

July 1, 2014

Study Completion

July 1, 2014

Last Updated

November 13, 2014

Record last verified: 2014-11

Locations

US(1)