N/A
Completed N=13
A Study to Assess the Effect of Smart Insulin Pens on Glycemic Control and Diabetes-related Burdens
Source: ClinicalTrials.gov NCT05036343 ↗Enrolled (actual)
13
Serious AEs
0.0%
Results posted
Jan 2024
Primary outcomePrimary: Glucose Time in Range — 46; 49 percentage of time in range
Summary
The purpose of this study is to see if the use of the InPen® for teens and young adults up to age 21 years with type 1 diabetes helps to decrease burden and improve glycemic control.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Glucose Time in Range |
46; 49 | — |
| PRIMARY InPen® Missed Insulin Injections |
51.2; 212.6 | — |
| PRIMARY Change in Hemoglobin A1c |
-0.1; -0.3 | — |
| PRIMARY Glucose |
198; 180 | — |
| SECONDARY Change in Diabetes Distress Scale Score |
-0.038; 0.075 | — |
| SECONDARY Change in Transition Readiness |
0.149; -0.029 | — |
| SECONDARY Change in Self-Efficacy for Managing Chronic Conditions - Managing Medications and Treatment Score |
0.058; 0.074 | — |
Eligibility Criteria
Inclusion Criteria
- Individuals between the ages of 13 and 21 years.
- Patients with Type 1 diabetes for at least 6 months
- Defined as either a c peptide <1 , one or more positive diabetes autoantibodies, or a clinical diagnosis with age of onset prior to puberty
- Patients who currently receive insulin injections with a CGM.
- English speaking.
- Have access to a smart phone. on an insulin to carbohydrate ratio
Exclusion Criteria
- Individuals less than 13
- Non-English speaking.
- No access to a smart phone.
- Intellectual disability that would impact their ability to utilize the technology
- Known pregnant women taking chronic steroids (equivalent equal to or greater then 5mg of prednisone daily)
Data sourced from ClinicalTrials.gov (NCT05036343). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.