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Type One Diabetes and Low Carb Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date July 14, 2016
First Posted Date July 20, 2016
Last Update Posted Date June 9, 2017
Actual Study Start Date September 2016
Actual Primary Completion Date January 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: July 18, 2016)
Hemoglobin A1C [ Time Frame: within 3 month of taking the survey ]
self reported, confirmed by professional diabetes care provider if possible
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: July 18, 2016)
  • total daily insulin dose [ Time Frame: within 3 month of taking the survey ]
    self reported, confirmed by professional diabetes care provider if possible
  • total daily dietary carbohydrate [ Time Frame: within 3 month of taking the survey ]
    self reported
  • diabetes-related complication rates - diabetic ketoacidosis, hypoglycemia [ Time Frame: timeframe since staring low carb diet (at least three months) ]
  • BMI [ Time Frame: within 3 month of taking the survey ]
    self reported, confirmed by professional diabetes care provider if possible
  • 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
  • patient-physician relationship [ Time Frame: within 3 month of taking the survey ]
    self reported, complemented by professional diabetes care provider if possible
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title 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
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.
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Cross-Sectional
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
Condition Diabetes Mellitus, Type 1
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: June 7, 2017)
340
Original Estimated Enrollment
 (submitted: July 18, 2016)
500
Actual Study Completion Date March 2017
Actual Primary Completion Date January 2017   (Final data collection date for primary outcome measure)
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.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 99 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT02839174
Other Study ID Numbers P00022864
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement
Plan to Share IPD: Yes
Plan Description: Deidentified data will be shared with external collaborators.
Responsible Party Belinda Lennerz, Boston Children's Hospital
Study Sponsor Boston Children's Hospital
Collaborators Not Provided
Investigators
Principal Investigator: Belinda Lennerz Boston Children's Hospital
PRS Account Boston Children's Hospital
Verification Date June 2017