Type One Diabetes and Low Carb Study

Completed

• Conditions: Diabetes Mellitus, Type 1

• Registration Number: NCT02839174
• Lead Sponsor: Boston Children's Hospital

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.

Basic Information
|
Recruitment & Eligibility
|
Study & Design
|
Trial Locations

Study Timeline

• Study First Submitted: 2016-07-14
• Study First Submitted QC: 2016-07-18
• Study First Posted: 2016-07-20
• Study Start: 2016-09
• Primary Completion: 2017-01
• Study Completion: 2017-03
• Status Verified: 2017-06
• Last Update Submitted: 2017-06-07
• Last Update Posted: 2017-06-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 340

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

Read More

Exclusion Criteria

• Women who are pregnant or breastfeeding.

Read More

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Hemoglobin A1C	within 3 month of taking the survey	self reported, confirmed by professional diabetes care provider if possible

Secondary Outcome Measures

Name	Time	Method
BMI	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)
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
total daily insulin dose	within 3 month of taking the survey	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

Trial Locations

Locations (1)

Boston Children's Hospital; 🇺🇸 Boston, Massachusetts, United States