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NCT04157738 · ClinicalTrials.gov registry record · Phase 4
A Study of Rapid-Acting Mealtime Insulin in Children and Adolescents With Newly Diagnosed Type 1 Diabetes Mellitus
A Phase 4 study of Diabetes Mellitus and Type 1 Diabetes, sponsored by Emory University.
- Completed
- Registry status
- Phase 4
- Development phase
- 24
- Enrollment target
- 1
- Study location
NCT04157738: Completed Phase 4 study of Diabetes Mellitus and Type 1 Diabetes, sponsored by Emory University.
NCT04157738 is a Phase 4 study of Diabetes Mellitus and Type 1 Diabetes that has completed, run by Emory University. The registered enrollment target is 24 participants, below the 1,867-participant average among 208 other Diabetes Mellitus 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
NCT04157738, a Phase 4 study of Diabetes Mellitus and Type 1 Diabetes, has completed, sponsored by Emory University.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 24 participants
- Enrollment target
- 1
- Study location
Study Summary
Type 1 diabetes mellitus (T1DM) is a challenging medical disorder, especially in children and adolescents. In order to prevent the chronic complications of hyperglycemia, the maintenance of near-normal glycemic control must be balanced with minimizing hypoglycemia. Although many pediatric endocrinologists provide an ICR plan for their newly diagnosed patients with T1DM, fixed dosing and other forms of insulin delivery are available. This proposal is designed to compare children and adolescents with newly diagnosed T1DM using a fixed insulin dose for fixed carbohydrate mealtime regimen (FIXED group) to children and adolescents with newly diagnosed T1DM using an ICR with variable carbohydrate intake (ICR group) mealtime regimen. In addition to determining the feasibility for a subsequently larger clinical trial, the aims of this investigator-initiated, prospective proposal, is twofold. The first is to determine if the caregivers of diabetics using a fixed insulin for fixed carbohydrate regimen (FIXED group) experience less anxiety than the caregivers of those using an ICR with variable carbohydrate intake regimen (ICR group) at 1- and 4-months post-randomization. The second is to determine if diabetics utilizing a fixed insulin for fixed carbohydrate regimen (FIXED group) have decreased glycemic variability (GV) than those using an ICR with variable carbohydrate intake regimen (ICR group) at 1- and 4-months post-randomization.
Primary Outcome
The capacity for recruitment was assessed, including all subjects that signed the Informed Consent Form (ICF).
Conditions Studied
Interventions
- DRUG Rapid-Acting Insulin
- DRUG Long acting insulin
Study Locations (1)
Georgia
- Children's Healthcare of Atlanta - Atlanta
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 24 participants |
| Start Date | 2019-11-27 |
| Est. Completion | 2020-12-17 |
| Phase | Phase 4 |
What the finished NCT04157738 record still lists
NCT04157738 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 24 participants, a relatively small participant target, below the 1,867-participant average among 208 other Diabetes Mellitus trials with a reported enrollment target (99% lower).
The record links to 2 conditions, with Diabetes Mellitus appearing as the primary indexed condition, and to 2 interventions - of which Rapid-Acting Insulin is the first listed.
NCT04157738 reports a single indexed study location in Georgia.
Frequently Asked Questions
What is clinical trial NCT04157738 about?
NCT04157738 is a clinical study titled "A Study of Rapid-Acting Mealtime Insulin in Children and Adolescents With Newly Diagnosed Type 1 Diabetes Mellitus". Type 1 diabetes mellitus (T1DM) is a challenging medical disorder, especially in children and adolescents. In order to prevent the chronic complications of hyperglycemia, the maintenance of near-normal glycemic control must be balanced with minimizing hypoglycemia. Although many pediatric endocrinol...
What is the current status of trial NCT04157738?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 24 participants. The study started on 2019-11-27. Estimated completion is 2020-12-17.
What conditions does trial NCT04157738 study?
This clinical trial studies the following conditions: Diabetes Mellitus, Type 1 Diabetes.
What interventions are being tested in trial NCT04157738?
The interventions under investigation include: Rapid-Acting Insulin (DRUG), Long acting insulin (DRUG).
Who is sponsoring clinical trial NCT04157738?
This trial is sponsored by Emory University, which has 1,208 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04157738 being conducted?
This trial has 1 study location across Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Diabetes Mellitus
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 NCT04157738's enrollment target sits among peer trials
24 188th of 208 higher than 18 of 208 other Diabetes Mellitus trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Diabetes Mellitus 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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