Clinical trial NCT05036343: A Study to Assess the Effect of Smart Insulin Pens on Glycemic Control and Diabetes-related Burdens
Official title: Smart Insulin Pens: A Randomized, Crossover Prospective Interventional Pilot Study Assessing the Effect on Glycemic Control and Diabetes Related Burdens
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 1 Diabetes
Keywords: Adolescents
Young Adults
Continuous Glucose monitoring (CGM)
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2021-09-05
Enrollment: 13
Sex: ALL
Minimum age (years): 13
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SUPPORTIVE_CARE

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.

Detailed description: 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.

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)

Primary outcomes:
measure: Glucose Time in Range
timeFrame: 3 months
measure: InPen® Missed Insulin Injections
timeFrame: 30 and 90 days
measure: Change in Hemoglobin A1c
timeFrame: Baseline, 3 months
measure: Glucose
timeFrame: 3 months
Secondary outcomes:
measure: Change in Diabetes Distress Scale Score
timeFrame: Baseline, 3 months
measure: Change in Transition Readiness
timeFrame: Baseline, 3 months
measure: Change in Self-Efficacy for Managing Chronic Conditions - Managing Medications and Treatment Score
timeFrame: Baseline, 3 months
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Ana Creo, MD
role: PRINCIPAL_INVESTIGATOR
References: