Diabetes Mellitus, Type 1
Conditions
Keywords
low carbohydrate diet
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.
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.
Interventions
None listed
Sponsors
Boston Children's Hospital
Study design
Observational model
COHORT
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Hemoglobin A1C | within 3 month of taking the survey | self reported, confirmed by professional diabetes care provider if possible |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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) | — |
| total daily insulin dose | 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 |
| BMI | within 3 month of taking the survey | self reported, confirmed by professional diabetes care provider if possible |
Countries
United States
Outcome results
None listed