Type One Diabetes and Low Carb Study

June 7, 2017 updated by: Belinda Lennerz, Boston Children's Hospital

Investigation of Glycemic Control Among an International Community of People With Type 1 Diabetes Following a Low Carbohydrate Diet

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.

Study Overview

Status

Completed

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

Enrollment (Actual)

340

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Boston Children's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 99 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hemoglobin A1C
Time Frame: within 3 month of taking the survey
self reported, confirmed by professional diabetes care provider if possible
within 3 month of taking the survey

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
total daily insulin dose
Time Frame: within 3 month of taking the survey
self reported, confirmed by professional diabetes care provider if possible
within 3 month of taking the survey
total daily dietary carbohydrate
Time Frame: within 3 month of taking the survey
self reported
within 3 month of taking the survey
diabetes-related complication rates - diabetic ketoacidosis, hypoglycemia
Time Frame: timeframe since staring low carb diet (at least three months)
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
within 3 month of taking the survey
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
current (within three months of taking the survey) - baseline (last available pre-carbohydrate-restricted diet)
patient-physician relationship
Time Frame: within 3 month of taking the survey
self reported, complemented by professional diabetes care provider if possible
within 3 month of taking the survey

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Belinda Lennerz, Boston Children's Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2016

Primary Completion (Actual)

January 1, 2017

Study Completion (Actual)

March 1, 2017

Study Registration Dates

First Submitted

July 14, 2016

First Submitted That Met QC Criteria

July 18, 2016

First Posted (Estimate)

July 20, 2016

Study Record Updates

Last Update Posted (Actual)

June 9, 2017

Last Update Submitted That Met QC Criteria

June 7, 2017

Last Verified

June 1, 2017

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Deidentified data will be shared with external collaborators.

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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