An observational study in Type 1 Diabetes, sponsored by Wayne State University. Active, not recruiting at 1 site in United States. Open to participants aged 13 Years to 21 Years. Per ClinicalTrials.gov, last updated 2026-08-20.
Sponsored by Wayne State University · Observational
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 study is to determine if use of the InPen will improve glycemic control and diabetes numeracy in adolescents with uncontrolled T1D living in urban areas.
3,522 studies on the registry are indexed under Diabetes Mellitus, Type 1; 576 are open to participants now.
This study's planned enrollment of 34 is below the median of 120 across 748 observational studies indexed under Diabetes Mellitus, Type 1.
Browse Diabetes Mellitus, Type 1 studies →Wayne State University is the lead sponsor of 226 studies on the registry; 35 are open to participants now.
Of its 17 completed or terminated interventional studies of FDA-regulated products, 4 (24%) have results posted.
Counted across the registry records on this site, refreshed daily.
Patients aged 13-21 years of age with Type 1 Diabetes who will be initiating treatment with the InPen insulin pen device
Patients using multiple daily injections of insulin (MDI); basal- bolus regimen requiring three or more injections per day.
Exclusion Criteria:
Patients who will begin using the InPen device as per standard of care
Device: InPen Insulin Pen
The InPen is a reusable smart insulin pen for people living with diabetes. The device uses Bluetooth technology to send dose information to a mobile application. The InPen can be used to deliver insulin, help calculate insulin doses, and estimate carbohydrates for meals
Change in Hemoglobin A1c (HbA1c)
Change in mean hemoglobin A1c (HbA1c) among patients from baseline to 12- and 24 weeks after using the InPen device in diabetes management plan.
Time frame: Baseline to 12 and 24 weeks (End of study)
Change in Diabetes Numeracy Test (DNT-14)
Assessment test designed to investigate numeracy skills in patients with diabetes
Time frame: Baseline and 24 weeks (end of study)
Clinical Evaluation of Treatment
Questionnaire to assess usability, comfort with, and usefulness of the InPen and its app.
Time frame: 24 weeks (end of study)
Documents are hosted by the registry — open the source record to download them.
This study is active, not recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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Wayne State University