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Type One Diabetes and Low Carb Study

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ClinicalTrials.gov Identifier: NCT02839174
Recruitment Status : Completed
First Posted : July 20, 2016
Last Update Posted : June 9, 2017
Sponsor:
Information provided by (Responsible Party):
Belinda Lennerz, 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.


Condition or disease
Diabetes Mellitus, Type 1

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.

Study Type : Observational
Actual Enrollment : 340 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Investigation of Glycemic Control Among an International Community of People With Type 1 Diabetes Following a Low Carbohydrate Diet
Actual Study Start Date : September 2016
Actual Primary Completion Date : January 2017
Actual Study Completion Date : March 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diabetes Type 1
U.S. FDA Resources




Primary Outcome Measures :
  1. Hemoglobin A1C [ Time Frame: within 3 month of taking the survey ]
    self reported, confirmed by professional diabetes care provider if possible


Secondary Outcome Measures :
  1. total daily insulin dose [ Time Frame: within 3 month of taking the survey ]
    self reported, confirmed by professional diabetes care provider if possible

  2. total daily dietary carbohydrate [ Time Frame: within 3 month of taking the survey ]
    self reported

  3. diabetes-related complication rates - diabetic ketoacidosis, hypoglycemia [ Time Frame: timeframe since staring low carb diet (at least three months) ]
  4. BMI [ Time Frame: within 3 month of taking the survey ]
    self reported, confirmed by professional diabetes care provider if possible

  5. change in HbA1C [ Time Frame: 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

  6. patient-physician relationship [ Time Frame: within 3 month of taking the survey ]
    self reported, complemented by professional diabetes care provider if possible



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02839174


Locations
United States, Massachusetts
Boston Children's Hospital
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
Boston Children’s Hospital
Investigators
Principal Investigator: Belinda Lennerz Boston Children’s Hospital

Responsible Party: Belinda Lennerz, Instructor in Pediatric Endocrinology, Boston Children’s Hospital
ClinicalTrials.gov Identifier: NCT02839174     History of Changes
Other Study ID Numbers: P00022864
First Posted: July 20, 2016    Key Record Dates
Last Update Posted: June 9, 2017
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Deidentified data will be shared with external collaborators.

Keywords provided by Belinda Lennerz, Boston Children’s Hospital:
low carbohydrate diet

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases