Type One Diabetes and Low Carb Study

NCT02839174 | Completed

• 1 other identifier: P00022864
• Study Type: observational
• Target: 340
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes Mellitus, Type 1

Keywords

low carbohydrate diet

Outcome Measures

Primary Outcomes (1)

• Hemoglobin A1C

  self reported, confirmed by professional diabetes care provider if possible

  within 3 month of taking the survey

Secondary Outcomes (6)

• total daily insulin dose

  within 3 month of taking the survey

• total daily dietary carbohydrate

  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

  within 3 month of taking the survey

• change in HbA1C

  current (within three months of taking the survey) - baseline (last available pre-carbohydrate-restricted diet)

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• Women who are pregnant or breastfeeding.

Sponsors & Collaborators

• Boston Children's Hospital: lead

Study Sites (1)

Boston Children's Hospital

Boston, Massachusetts, 02115, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Belinda Lennerz

  Boston Children's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Instructor in Pediatric Endocrinology

Study Record Dates

• First Submitted: July 14, 2016
• First Posted: July 20, 2016
• Study Start: September 1, 2016
• Primary Completion: January 1, 2017
• Study Completion: March 1, 2017
• Last Updated: June 9, 2017

Record last verified: 2017-06

Data Sharing

• IPD Sharing: Will share

Locations

US (1)