Type One Diabetes and Low Carb Study
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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Detailed Description
The surveys will address questions in the following domains: 1) Diabetes diagnosis and treatment; 2) Carbohydrate-restricted diet; 3) Insulin regimen; 4) Other diabetes related care; 5) Diabetes complications; 6) Other related health and healthcare; 7) Patient provider interactions; 8) Socio-demographics. Drafts of these surveys are included in the appendix of this protocol.
Study Design
Outcome Measures
Primary Outcome Measures
- Hemoglobin A1C [within 3 month of taking the survey]
self reported, confirmed by professional diabetes care provider if possible
Secondary Outcome Measures
- total daily insulin dose [within 3 month of taking the survey]
self reported, confirmed by professional diabetes care provider if possible
- total daily dietary carbohydrate [within 3 month of taking the survey]
self reported
- diabetes-related complication rates - diabetic ketoacidosis, hypoglycemia [timeframe since staring low carb diet (at least three months)]
- BMI [within 3 month of taking the survey]
self reported, confirmed by professional diabetes care provider if possible
- change in HbA1C [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
- patient-physician relationship [within 3 month of taking the survey]
self reported, complemented by professional diabetes care provider if possible
Eligibility Criteria
Criteria
Inclusion Criteria:
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Adult patients with a diagnosis of T1DM who are currently on insulin treatment or
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Adults who are a parent or guardian of a child with T1DM who is currently on insulin treatment and
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Self-reported use of a regimen including carbohydrate restriction for at least 3 months
Exclusion Criteria:
- Women who are pregnant or breastfeeding.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Boston Children's Hospital | Boston | Massachusetts | United States | 02115 |
Sponsors and Collaborators
- Boston Children's Hospital
Investigators
- Principal Investigator: Belinda Lennerz, Boston Children's Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- P00022864