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

NCT05036343 | Completed Results FDA Device

• 1 other identifier: 21-004938
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

Brief 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

Type 1 Diabetes

Keywords

Adolescents; Young Adults; Continuous Glucose monitoring (CGM)

Outcome Measures

Primary Outcomes (4)

• Glucose Time in Range

  The percentage of time that glucose readings are in goal range (70-180 mg/dL)

  3 months

• InPen® Missed Insulin Injections

  Number of missed insulin injections after 30 and 90 days of InPen and CGM

  30 and 90 days

• Change in Hemoglobin A1c

  Hemoglobin is a protein within red blood cells. As glucose enters the bloodstream, it binds to hemoglobin, or glycates. The more glucose that enters the bloodstream, the higher the amount of glycated hemoglobin. An A1C level below 5.7 percent is considered normal. Unit of measure = percent of glycated hemoglobin

  Baseline, 3 months

• Glucose

  Mean glucose levels at 6 months. Sugar in the form of glucose in the blood. The concentration of glucose in the blood. A healthy normal range is 70 to 99 mg/dL

  3 months

Secondary Outcomes (3)

• Change in Diabetes Distress Scale Score

  Baseline, 3 months

• Change in Transition Readiness

  Baseline, 3 months

• Change in Self-Efficacy for Managing Chronic Conditions - Managing Medications and Treatment Score

  Baseline, 3 months

Study Arms (2)

InPen® and CGM, then standard of care and CGM

EXPERIMENTAL

Adolescents and young adults (13-21 years) identified with having type 1 diabetes and currently receiving insulin injections with a continuous glucose monitor (CGM) will use the InPen® and CGM for the first 90 days then switch to standard of care with traditional insulin injections and CGM for 90 days.

Device: InPen®

Standard of care and CGM, then InPen® and CGM

EXPERIMENTAL

Adolescents and young adults (13-21 years) identified with having type 1 diabetes and currently receiving insulin injections with a continuous glucose monitor (CGM) will receive standard of care with traditional insulin injections and CGM for first 90 days then switch to the InPen® and CGM for 90 days.

Device: InPen®

Interventions

InPen® DEVICE

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.

InPen® and CGM, then standard of care and CGM; Standard of care and CGM, then InPen® and CGM

Eligibility Criteria

• Age: 13 Years - 21 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Results Point of Contact

• Title: Ana L. Creo, M.D.
• Organization: Mayo Clinic

Creo.Ana@mayo.edu

507-284-3300

Study Officials

• Ana Creo, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 2, 2021
• First Posted: September 5, 2021
• Study Start: September 14, 2021
• Primary Completion: November 30, 2022
• Study Completion: November 30, 2022
• Last Updated: January 2, 2024
• Results First Posted: January 2, 2024

Record last verified: 2023-12

Locations

US (1)