Clinical trial NCT02839174: Type One Diabetes and Low Carb Study
Official title: Investigation of Glycemic Control Among an International Community of People With Type 1 Diabetes Following a Low Carbohydrate Diet
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetes Mellitus, Type 1
Keywords: low carbohydrate diet
Lead sponsor: Boston Children's Hospital
Sponsor class: OTHER
First posted: 2016-07-20
Enrollment: 340
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The social media group on Facebook, TYPEONEGRIT, includes approximately 1500 members, the majority of whom reportedly have type 1 diabetes and follow a carbohydrate-restricted 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Hemoglobin A1C
timeFrame: within 3 month of taking the survey
Secondary outcomes:
measure: total daily insulin dose
timeFrame: within 3 month of taking the survey
measure: total daily dietary carbohydrate
timeFrame: within 3 month of taking the survey
measure: diabetes-related complication rates - diabetic ketoacidosis, hypoglycemia
timeFrame: timeframe since staring low carb diet (at least three months)
measure: BMI
timeFrame: within 3 month of taking the survey
measure: change in HbA1C
timeFrame: current (within three months of taking the survey) - baseline (last available pre-carbohydrate-restricted diet)
measure: patient-physician relationship
timeFrame: within 3 month of taking the survey
Other outcomes:
Locations:
city: Boston
country: United States
facility: Boston Children's Hospital
state: Massachusetts
Study officials:
affiliation: Boston Children's Hospital
name: Belinda Lennerz
role: PRINCIPAL_INVESTIGATOR
References: