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OpenTrials
Completed

NCT Number: NCT02839174

Type One Diabetes and Low Carb Study

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.

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Key information

Conditions

Diabetes Mellitus, Type 1 Autoimmune Diseases Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Immune System Diseases Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Boston Children's Hospital

Boston, Massachusetts, 02115, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Hemoglobin A1C

    Time frame: within 3 month of taking the survey

    self reported, confirmed by professional diabetes care provider if possible

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Boston Children's Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Jul 20, 2016
Registry last updated
Jun 9, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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