Type One Diabetes and Low Carb Study

NCT ID: NCT02839174

Last Updated: 2017-06-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

340 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-09-30

Study Completion Date

2017-03-31

Brief Summary

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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

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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.

Conditions

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Diabetes Mellitus, Type 1

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Boston Children's Hospital

OTHER

Sponsor Role lead

Responsible Party

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Belinda Lennerz

Instructor in Pediatric Endocrinology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Belinda Lennerz

Role: PRINCIPAL_INVESTIGATOR

Boston Children's Hospital

Locations

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Boston Children's Hospital

Boston, Massachusetts, United States

Site Status

Countries

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United States

Other Identifiers

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P00022864

Identifier Type: -

Identifier Source: org_study_id

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