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A Study to Assess the Effect of Smart Insulin Pens on Glycemic Control and Diabetes-related Burdens

NCT05036343 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 13

Last updated 2024-01-02

Study results available
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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.

Conditions

Interventions

DEVICE

InPen®

A smartpen that has been FDA approved for children with diabetes age seven years and older that uses an app on a smartphone to help calculate insulin doses using the amount of carbohydrates that will be consumed at a meal along with what the current blood sugar reading is, to give a correction dose as well. The InPen app also serves as a log book to record insulin doses given, blood sugar at the time of a meal, and amount of carbohydrate eaten.

Sponsors & Collaborators

Principal Investigators

  • Ana Creo, MD · Mayo Clinic

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
13 Years
Max Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-09-14
Primary Completion
2022-11-30
Completion
2022-11-30
FDA Device
Yes

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05036343 on ClinicalTrials.gov