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NCT03710928 · ClinicalTrials.gov registry record · NA
Type 1 Diabetes Management Using a Very Low Carbohydrate Versus Standard Diet
A NA study of Type 1 Diabetes, sponsored by Boston Children's Hospital.
- Recruiting
- Registry status
- NA
- Development phase
- 32
- Enrollment target
- 1
- Study location
NCT03710928: Recruiting NA study of Type 1 Diabetes, sponsored by Boston Children's Hospital.
NCT03710928 is a NA study of Type 1 Diabetes that is actively recruiting participants, run by Boston Children's Hospital. The registered enrollment target is 32 participants, below the 767-participant average among 198 other Type 1 Diabetes trials with a reported enrollment target (96% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03710928, a NA study of Type 1 Diabetes, is actively recruiting participants, sponsored by Boston Children's Hospital.
- RECRUITING
- Registry status
- NA
- Development phase
- 32 participants
- Enrollment target
- 1
- Study location
Study Summary
Despite major technological advances, management of type one diabetes mellitus (T1D) remains suboptimal, putting millions of people at risk for immediate and long-term complications. After meals, a mismatch between carbohydrate absorption rate and insulin action typically leads to alternating periods of hyper- and hypoglycemia. A conceptually promising approach to control both problems is dietary carbohydrate restriction to reduce postprandial blood glucose changes and insulin needs. In a prior survey study, the investigators documented exceptional glycemic control (HbA1c 5.67%) and low acute complication rates among 316 children and adults with T1D consuming a very-low-carbohydrate diet. To test the feasibility of this approach, the investigators will conduct a randomized-controlled feeding study involving 32 adults and adolescents with T1D. Participants will be randomized to receive a very low carbohydrate vs. standard carbohydrate diet. Participants will be in the study for 12 weeks and receive all their meals by meal delivery.They will share continuous glucose monitoring data with the study team and be in close communication to adjust insulin doses as needed. All participants will have a screening visit, an individual or group education session, and 3 study visits to evaluate diabetes control and metabolic health. Some of these visits will have a fasting blood draw. Two of the visits will also comprise additional metabolic studies to assess glucagon response and brain function during hypoglycemia by magnetic resonance imaging (MRI). Participants will have IV catheters placed and receive IV insulin to drop blood glucose levels to 50 mg/dl for up to 30 minutes. The primary outcome will be HbA1c change from baseline. Secondary outcomes include detailed measures of glycemic variability, metabolic health, and quality of life.
Primary Outcome
HbA1C change from baseline at 12 weeks will be compared between the 2 interventions
Conditions Studied
Interventions
- OTHER very low carbohydrate diet
- OTHER standard carbohydrate diet
Study Locations (1)
Massachusetts
- Boston Children's Hospital - Boston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 32 participants |
| Start Date | 2020-01-03 |
| Est. Completion | 2026-07-31 |
| Phase | NA |
What NCT03710928 shows while recruiting
NCT03710928 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 32 participants, a relatively small participant target, below the 767-participant average among 198 other Type 1 Diabetes trials with a reported enrollment target (96% lower).
The record links to 1 condition, with Type 1 Diabetes appearing as the primary indexed condition, and to 2 interventions - of which very low carbohydrate diet is the first listed.
NCT03710928 reports a single indexed study location in Massachusetts.
Frequently Asked Questions
What is clinical trial NCT03710928 about?
NCT03710928 is a clinical study titled "Type 1 Diabetes Management Using a Very Low Carbohydrate Versus Standard Diet". Despite major technological advances, management of type one diabetes mellitus (T1D) remains suboptimal, putting millions of people at risk for immediate and long-term complications. After meals, a mismatch between carbohydrate absorption rate and insulin action typically leads to alternating period...
What is the current status of trial NCT03710928?
This trial is currently recruiting. It is a NA study. The enrollment target is 32 participants. The study started on 2020-01-03. Estimated completion is 2026-07-31.
What conditions does trial NCT03710928 study?
This clinical trial studies the following conditions: Type 1 Diabetes.
What interventions are being tested in trial NCT03710928?
The interventions under investigation include: very low carbohydrate diet (OTHER), standard carbohydrate diet (OTHER).
Who is sponsoring clinical trial NCT03710928?
This trial is sponsored by Boston Children's Hospital, which has 462 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03710928 being conducted?
This trial has 1 study location across Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT03710928's enrollment target sits among peer trials
32 124th of 198 higher than 73 of 198 other Type 1 Diabetes trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Type 1 Diabetes trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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