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

Study Overview
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Brief Summary
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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.

Detailed Description
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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 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.

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

Conditions
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Type 1 Diabetes

Intervention / Treatment
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* Device: InPen®


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 13 Years
Maximum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: InPen® and CGM, then standard of care and CGM<br>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 CMG for the first 90 days then switch to standard of care with traditional insulin injections and CMG for 90 days. | Device: InPen®<br>* 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.<br>|
| Experimental: Standard of care and CGM, then InPen® and CGM<br>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 CMG for first 90 days then switch to the InPen® and CMG for 90 days. | Device: InPen®<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Glucose time in range | Amount of time in glucose goal range (70-180 mg/dL) | 6 months | 
| Missed insulin injections | Number of missed insulin injections | 6 months | 
| Hemoglobin A1c level | Change in hemoglobin A1c blood levels | Baseline, 3 months, 6 months | 
| 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) | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in diabetes distress | 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 | Baseline, 6 months | 
| Change in transition readiness | Measured using the Transition Readiness Assessment Questionnaire (TRAQ) 20 item questionnaire assessing the skill levels that are important for transition to adult health care. | Baseline, 6 months | 
| Change in parental experience of childhood illness | Measured using a self-reported questionnaire asking a parent to rate the confidence level for in managing chronic conditions, medications and treatment; using a scale of 1 = I am not at all confident, 5 = I am very confident | Baseline, 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Adolescents, Young Adults, Continuous Glucose monitoring (CGM)