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NCT04228822 · ClinicalTrials.gov registry record · NA
Safety and Feasibility of a Low Carbohydrate Diet in Children With Type 1 Diabetes
A NA study of Type 1 Diabetes, sponsored by Washington University School of Medicine.
- Completed
- Registry status
- NA
- Development phase
- 8
- Enrollment target
- 1
- Study location
NCT04228822: Completed NA study of Type 1 Diabetes, sponsored by Washington University School of Medicine.
NCT04228822 is a NA study of Type 1 Diabetes that has completed, run by Washington University School of Medicine. The registered enrollment target is 8 participants, below the 767-participant average among 198 other Type 1 Diabetes trials with a reported enrollment target (99% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04228822, a NA study of Type 1 Diabetes, has completed, sponsored by Washington University School of Medicine.
- COMPLETED
- Registry status
- NA
- Development phase
- 8 participants
- Enrollment target
- 1
- Study location
Study Summary
Good glycemic control in individuals with Type 1 diabetes (T1D), has been proven to reduce the risk of diabetes-related complications. Despite technological advances such as the use of insulin delivery devices and continuous glucose monitoring, the average glycemic control in T1D is poor. Though dietary management plays a major role in the overall management of T1D, and it is often classified as the most challenging aspect of treatment, the 2019 Standards of Medical Care in Diabetes for children and adolescents do not clearly address dietary management. As carbohydrate is the macronutrient with the greatest impact on blood glucose, it is reasonable to suggest that carbohydrate reduction will minimize postprandial glucose excursions and improve diabetes control. For this reason, low carbohydrate diets (LCD) have gained popularity, and observational studies report positive glycemic outcomes. However, to date, scientific evidence from randomized trials on the impact of LCD in children with T1D is lacking. Thus, the over-arching goal of this pilot study is to evaluate the feasibility and safety of a low carbohydrate diet in children with T1D, and as an exploratory aim, we will evaluate the efficacy of LCD on glycemic control.
Primary Outcome
Using a continuous glucose monitor (CGM) and home glucose meter, investigators will calculate the number of hypoglycemic events (glucose values \<70 mg/dL but ≥ 54 mg/dL and those \<54 mg/dL), number of severe hypoglycemia and time spent in hypoglycemia (values \<70 mg/dL but ≥ 54 mg/dL and \<54 mg/dL).
Conditions Studied
Interventions
- OTHER Low carbohydrate diet
Study Locations (1)
Missouri
- St Louis Children's Hospital - St Louis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 8 participants |
| Start Date | 2020-11-10 |
| Est. Completion | 2022-02-28 |
| Phase | NA |
What the finished NCT04228822 record still lists
NCT04228822 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 8 participants, a relatively small participant target, below the 767-participant average among 198 other Type 1 Diabetes trials with a reported enrollment target (99% lower).
The record links to 1 condition, with Type 1 Diabetes appearing as the primary indexed condition, and to 1 intervention - of which Low carbohydrate diet is the first listed.
NCT04228822 reports a single indexed study location in Missouri.
Frequently Asked Questions
What is clinical trial NCT04228822 about?
NCT04228822 is a clinical study titled "Safety and Feasibility of a Low Carbohydrate Diet in Children With Type 1 Diabetes". Good glycemic control in individuals with Type 1 diabetes (T1D), has been proven to reduce the risk of diabetes-related complications. Despite technological advances such as the use of insulin delivery devices and continuous glucose monitoring, the average glycemic control in T1D is poor. Though die...
What is the current status of trial NCT04228822?
This trial is currently completed. It is a NA study. The enrollment target is 8 participants. The study started on 2020-11-10. Estimated completion is 2022-02-28.
What conditions does trial NCT04228822 study?
This clinical trial studies the following conditions: Type 1 Diabetes.
What interventions are being tested in trial NCT04228822?
The interventions under investigation include: Low carbohydrate diet (OTHER).
Who is sponsoring clinical trial NCT04228822?
This trial is sponsored by Washington University School of Medicine, which has 1,502 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04228822 being conducted?
This trial has 1 study location across Missouri. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Type 1 Diabetes
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04228822's enrollment target sits among peer trials
8 192nd of 198 higher than 6 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.
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