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

Launched by MAYO CLINIC · Sep 2, 2021

Keywords

ClinConnect Summary

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...

Gender

ALL

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)