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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 Type1diabetes, sponsored by Boston Children's Hospital.
- Recruiting
- Registry status
- NA
- Development phase
- 32
- Enrollment target
- 1
- Study location
NCT03710928 is a NA study of Type1diabetes that is actively recruiting participants, run by Boston Children's Hospital. The registered enrollment target is 32 participants, below the 260-participant average among 19 other Type1diabetes trials with a reported enrollment target (88% lower). The trial reports 1 study location across 1 state.
The verdict
NCT03710928, a NA study of Type1diabetes, 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.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03710928
The ClinicalTrials.gov registry entry for NCT03710928 describes a study currently listed as recruiting, categorized as NA. The registered enrollment target is 32 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 260-participant average among 19 other Type1diabetes trials with a reported enrollment target (88% lower). The listed sponsor is Boston Children's Hospital, which has 462 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Type1diabetes appearing as the primary indexed condition, and to 2 interventions - of which very low carbohydrate diet is the first listed.
NCT03710928 reports 1 study location spanning 1 distinct geographic area - top geographies include 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: Type1diabetes.
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.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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