Type One Diabetes and Low Carb Study

Boston Children's Hospital

Status: Completed

Conditions: Diabetes Mellitus, Type 1

Study type: Observational

Funder types: Other

Identifiers

NCT02839174

P00022864

Details and patient eligibility

About

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.

Full 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.

Enrollment: 340 patients

Sex: All

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

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.