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NCT05515939 · ClinicalTrials.gov registry record
Evaluating the InPen in Pediatric Type 1 Diabetes
A clinical trial of Type 1 Diabetes, sponsored by Wayne State University.
- Active
- Registry status
- 34
- Enrollment target
- 1
- Study location
NCT05515939: Active study of Type 1 Diabetes, sponsored by Wayne State University.
NCT05515939 is a study of Type 1 Diabetes that is active but no longer recruiting, run by Wayne State University. The registered enrollment target is 34 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
NCT05515939, a study of Type 1 Diabetes, is active but no longer recruiting, sponsored by Wayne State University.
- ACTIVE NOT RECRUITING
- Registry status
- 34 participants
- Enrollment target
- 1
- Study location
Study Summary
Type 1 Diabetes (T1D) is the most common form of diabetes affecting children, requiring lifelong administration of insulin to prevent complications. The incidence of T1D has increased more among African Americans, Hispanics, and Asian/Pacific Islanders compared to Caucasian youths in the past two decades. Despite advances in insulin delivery systems, fewer black and Hispanic children compared to white children with T1D use insulin pumps. Therefore, most minority children with T1D in urban areas require multiple daily injections (MDI) of insulin which may put them at increased risk of poor glycemic control. Although several factors contribute to worsening glycemic control in adolescents with T1D, studies have shown that missing doses of insulin at mealtimes is a major factor. Adolescents with T1D who use MDI with a basal-bolus regimen use formulas to calculate insulin doses that involve a four-step process. The complexity of determining insulin doses contributes to inaccuracies in both timing of doses and amount of insulin given, both of which can lead to hyperglycemia and hypoglycemia. The InPen™ Smart Insulin Pen System (Medtronics) was approved by the FDA for children of all ages with T1D in June 2020. The InPen is a Bluetooth-enabled smart insulin pen that helps with management of insulin dosing and tracking via capture of rapid-acting insulin doses and tracking of insulin in the body through the use of its companion app (free on Apple iOS and Android). The app includes a bolus calculator, which can lead to more accurate insulin dosing, which may improve glycemic control. The specific benefits of using the InPen include the following: simplifying insulin dose calculations, administering more accurate insulin doses, tracking insulin doses to help prevent hypoglycemia, providing reminders to administer insulin, and storing data in the InPen App that can be easily shared with diabetes healthcare teams to assist with adjusting insulin doses. The goal of this stud
Primary Outcome
Change in mean hemoglobin A1c (HbA1c) among patients from baseline to 12- and 24 weeks after using the InPen device in diabetes management plan.
Conditions Studied
Interventions
- DEVICE InPen Insulin Pen
Study Locations (1)
Michigan
- Wayne State University - Detroit
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 34 participants |
| Start Date | 2022-09-09 |
| Est. Completion | 2026-12-01 |
What the registry record for NCT05515939 still lists
NCT05515939 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 34 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 1 intervention - of which InPen Insulin Pen is the first listed.
NCT05515939 reports a single indexed study location in Michigan.
Frequently Asked Questions
What is clinical trial NCT05515939 about?
NCT05515939 is a clinical study titled "Evaluating the InPen in Pediatric Type 1 Diabetes". Type 1 Diabetes (T1D) is the most common form of diabetes affecting children, requiring lifelong administration of insulin to prevent complications. The incidence of T1D has increased more among African Americans, Hispanics, and Asian/Pacific Islanders compared to Caucasian youths in the past two de...
What is the current status of trial NCT05515939?
This trial is currently active not recruiting. The enrollment target is 34 participants. The study started on 2022-09-09. Estimated completion is 2026-12-01.
What conditions does trial NCT05515939 study?
This clinical trial studies the following conditions: Type 1 Diabetes.
What interventions are being tested in trial NCT05515939?
The interventions under investigation include: InPen Insulin Pen (DEVICE).
Who is sponsoring clinical trial NCT05515939?
This trial is sponsored by Wayne State University, which has 163 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05515939 being conducted?
This trial has 1 study location across Michigan. 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 NCT05515939's enrollment target sits among peer trials
34 118th of 198 higher than 79 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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