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Completed

NCT Number: NCT05036343

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

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.

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Key information

Age range

13 year–21 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

About this study

Investigators will perform a randomized, cross-over prospective interventional study. Half of the participants will be randomized to the InPen® and the other half will continue with their conventional insulin injection protocol. After 90 days, participants will switch to the second arm. Randomization will occur via block randomization. Teaching to use the InPen® will be done by Sarah Jackson, DO with supervision by Ana Creo, MD, which can be done by a telemedicine visit if it does not align with clinic visit. You will be followed for three months with hemoglobin A1c at the beginning and the end of the study. Data from the (Continuous Glucose Monitor (CGM) and InPen® will be analyzed including time in glucose goal range (70-180 mg/dL), glucose standard deviation, percentage of time that is spent high (>180-250 mg/dL), very high(> 250 mg/dL), low(54-70 mg/dL) and very low(<54 mg/dL), along with total daily insulin dose. Data on missed insulin doses will be assessed via data from the InPen®. You will be randomized to traditional injections we will ask them to record missed insulin doses weekly. You should still adjust insulin doses at home, like they do at baseline. If insulin adjustments are made while in one arm of the study they should still continue that dosing when they cross over. Investigators will also assess quality of life and fatigue related to technology with surveys prior to start of the study and at the end. Specifically, investigators will assess diabetes distress, transition readiness, and parental experience of childhood illness scales. Investigators will also utilize the insulin delivery satisfaction survey to assess how you view your current regimen and then how you view the effects of the InPen in managing your type 1 diabetes.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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.

Primary outcomes

  1. Glucose Time in Range

    Time frame: 3 months

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

  2. InPen® Missed Insulin Injections

    Time frame: 30 and 90 days

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

  3. Change in Hemoglobin A1c

    Time frame: Baseline, 3 months

    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

  4. Glucose

    Time frame: 3 months

    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

Secondary outcomes

  1. Change in Diabetes Distress Scale Score

    Time frame: Baseline, 3 months

    Measured using the Diabetes Distress Scale (DDS) which identifies 17 potential problem areas that people with diabetes may experience and asked subjects to rate their perceived degree of distressed during the past month; using a scale of 1 = "Not a problem at all", 6 = "A very serious problem." Total scores range from 17-102, lower scores indicating less distress and higher scores indicating more distress

  2. Change in Transition Readiness

    Time frame: Baseline, 3 months

    Mean change in transition readiness as measured by using the Transition Readiness Assessment Questionnaire (TRAQ). A 20-item questionnaire assessing the skill levels that are important for transition to adult health care; using a scale of 1 = "No, I do not know how", 5 = "Yes, I always do this when I need to." Total scores range from 20 - 100, lower scores indicating lower readiness and higher scores indicating greater readiness.

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

    Time frame: Baseline, 3 months

    Measured using the Self-Efficacy for Managing Chronic Conditions - Managing Medications and Treatment questionnaire. A 14-item questionnaire rating the confidence level for managing chronic conditions, medications and treatment; using a scale of 1 = "I am not at all confident", 5 = "I am very confident." Total scores range from 14-70, lower scores indicating lower confidence and higher scores indicating higher confidence.

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Official study title

Smart Insulin Pens: A Randomized, Crossover Prospective Interventional Pilot Study Assessing the Effect on Glycemic Control and Diabetes Related Burdens

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Sep 5, 2021
Registry last updated
Jan 2, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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