Type 1 DiabetesNCT02190669
Exercise and Diabetes - an Observational Study of Exercise and Blood Glucose Control
An observational study of Type 1 Diabetes and Type 2 Diabetes, run by Sansum Diabetes Research Institute at 1 site in United States.
Trial summary
This proposal seeks to gather continuous blood glucose and physical activity data from individuals with and without diabetes. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Type 1 Diabetes, Type 2 Diabetes
- What is being tested?
- exercise
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2014to Jul 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: individuals without diabetes and those with type 1 and type 2 diabetes
Who may be able to join
- 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
Who cannot join
- unwilling to perform repeated glucose checks or take insulin as instructed
- abnormal thyroid function, kidney function, liver function
- pregnancy
Trial locations and contacts
1 site in 1 country.
United States1 site
Sansum Diabetes Research Institute
Santa Barbara, California, 93105
About this study
This proposal seeks to gather continuous blood glucose and physical activity data from individuals with and without diabetes.
Read the 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.
- Conditions
- Type 1 Diabetes, Type 2 Diabetes
- Being tested
- exercise
- Medical subject headings
- Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
exerciseOther
Sprinting, walking on a treadmill, and stationary bicycle riding
| Study group | Role | What they receive |
|---|---|---|
| exercise in individuals without diabetes | exercise in individuals without diabetes Receives: Other: exercise | |
| exercise in type 1 diabetes | exercise in type 1 diabetes Receives: Other: exercise | |
| exercise in type 2 diabetes | exercise in type 2 diabetes Receives: Other: exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Document the glycemic response of individuals without diabetes and with type 1 or type 2 diabetes
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2014 (estimated)
- Study startJun 2014
- Primary completionJul 2014
- Study completionJul 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 1 DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sansum Diabetes Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kristin Castorino, D.O., Principal investigator, Sansum Diabetes Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02190669
- Sponsor's protocol ID
- 08-67
- Status last verified
- Nov 2014
- First submitted
- 11 Jul 2014
- Last updated
- 13 Nov 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exercise and Diabetes - an Observational Study of Exercise and Blood Glucose Control
- ClinicalTrials.gov ID
- NCT02190669
- Acronym / sponsor ID
- 08-67
- Conditions
- Type 1 Diabetes, Type 2 Diabetes
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Sansum Diabetes Research InstituteUniversity, hospital or other
- Study start
- Jun 2014
- Primary completion
- Jul 2014 (actual)
- Study completion
- Jul 2014 (actual)
- First posted
- 15 Jul 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This proposal seeks to gather continuous blood glucose and physical activity data from individuals with and without diabetes.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| exercise in individuals without diabetes | – | Other: exerciseexercise in individuals without diabetes |
| exercise in type 1 diabetes | – | Other: exerciseexercise in type 1 diabetes |
| exercise in type 2 diabetes | – | Other: exerciseexercise in type 2 diabetes |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- individuals without diabetes and those with type 1 and type 2 diabetes
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (3 listed)
- unwilling to perform repeated glucose checks or take insulin as instructed
- abnormal thyroid function, kidney function, liver function
- pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| exerciseSprinting, walking on a treadmill, and stationary bicycle riding | Other | exercise in individuals without diabetes, exercise in type 1 diabetes, exercise in type 2 diabetes |
Primary outcome
Document the glycemic response of individuals without diabetes and with type 1 or type 2 diabetes
Time frame: 7 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2014.
Related trials for Type 1 Diabetes
Not yet recruitingPhase 3
A Study to Evaluate the Effectiveness and Safety of the Drug AZD6234 for Managing Weight in Adults Who Are Obese or Overweight. These Participants May or May Not Also Have Type 2 Diabetes
Obesity, Overweight
RecruitingPhase 1
Pharmacokinetics, Safety, and Immunogenicity Comparison of Bmab1700 and Opdivo® as Adjuvant Monotherapy in Participants With Melanoma
Melanoma
Active, not recruitingPhase 2
A Study of Botensilimab and Balstilimab for the Treatment of Colorectal Cancer
Metastatic Colorectal Cancer
Not yet recruiting
Inter-Arm Differences in Continuous Glucose Monitor Readings in Adults With Diabetes
Continuous Glucose Monitoring, Type 1 Diabetes
RecruitingObservational study
Estimated Risk of Preeclampsia in the First Trimester and Its Association With Subclinical Atherosclerosis and Cardiovascular Risk in Women With Type 1 Diabetes
Type 1 Diabetes, Preeclampsia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kristin Castorino, D.O. principal investigator
Sansum Diabetes Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Type 1 Diabetes and Type 2 Diabetes, run by Sansum Diabetes Research Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Nov 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Document the glycemic response of individuals without diabetes and with type 1 or type 2 diabetes (time frame: 7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Nov 2014.