Type One Diabetes and Low Carb Study

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Investigation of Glycemic Control Among an International Community of People With Type 1 Diabetes Following a Low Carbohydrate Diet

Conditions
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Diabetes Mellitus, Type 1

Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hemoglobin A1C | 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 | self reported, confirmed by professional diabetes care provider if possible | within 3 month of taking the survey | 
| total daily dietary carbohydrate | self reported | within 3 month of taking the survey | 
| diabetes-related complication rates - diabetic ketoacidosis, hypoglycemia |  | timeframe since staring low carb diet (at least three months) | 
| BMI | self reported, confirmed by professional diabetes care provider if possible | within 3 month of taking the survey | 
| change in HbA1C | 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 | self reported, complemented by professional diabetes care provider if possible | within 3 month of taking the survey | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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low carbohydrate diet