- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02839174
Type One Diabetes and Low Carb Study
Investigation of Glycemic Control Among an International Community of People With Type 1 Diabetes Following a Low Carbohydrate Diet
The investigators have identified a support group on social media with ~1500 members (children and adults), the majority of whom have T1DM and follow a carbohydrate-restricted diet. Many participants report exceptionally low HbA1C and insulin requirements. If these anecdotal reports are reflective of a large group of people with type 1 diabetes, a clinical trial would be warranted.
The investigators propose to survey the above-mentioned group and their professional diabetes care providers to characterize glycemic control and explore associated dietary and diabetes care factors.
Study Overview
Status
Conditions
Detailed Description
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
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Massachusetts
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Boston, Massachusetts, United States, 02115
- Boston Children's Hospital
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Adult patients with a diagnosis of T1DM who are currently on insulin treatment or
- Adults who are a parent or guardian of a child with T1DM who is currently on insulin treatment and
- Self-reported use of a regimen including carbohydrate restriction for at least 3 months
Exclusion Criteria:
- Women who are pregnant or breastfeeding.
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Hemoglobin A1C
Time Frame: within 3 month of taking the survey
|
self reported, confirmed by professional diabetes care provider if possible
|
within 3 month of taking the survey
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
total daily insulin dose
Time Frame: within 3 month of taking the survey
|
self reported, confirmed by professional diabetes care provider if possible
|
within 3 month of taking the survey
|
total daily dietary carbohydrate
Time Frame: within 3 month of taking the survey
|
self reported
|
within 3 month of taking the survey
|
diabetes-related complication rates - diabetic ketoacidosis, hypoglycemia
Time Frame: timeframe since staring low carb diet (at least three months)
|
timeframe since staring low carb diet (at least three months)
|
|
BMI
Time Frame: within 3 month of taking the survey
|
self reported, confirmed by professional diabetes care provider if possible
|
within 3 month of taking the survey
|
change in HbA1C
Time Frame: current (within three months of taking the survey) - baseline (last available pre-carbohydrate-restricted diet)
|
self reported, confirmed by professional diabetes care provider if possible
|
current (within three months of taking the survey) - baseline (last available pre-carbohydrate-restricted diet)
|
patient-physician relationship
Time Frame: within 3 month of taking the survey
|
self reported, complemented by professional diabetes care provider if possible
|
within 3 month of taking the survey
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Belinda Lennerz, Boston Children's Hospital
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- P00022864
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
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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