University of Kansas Medical Center

mHealth Insulin Titration and Management (iSage)

Purpose

The purpose of this study is to determine the benefits of using the iSage app for basal insulin titration and support. By doing this study the investigators hope to learn whether the app improves the participant's ability to follow his/her healthcare provider's instructions to adjust his/her insulin doses.

Condition

Type 2 Diabetes Mellitus

Eligibility

Eligible Ages: Over 21 Years
Eligible Genders: All
Accepts Healthy Volunteers: No

Inclusion Criteria

Diagnosed Type 2 Diabetes, based on the World Health Organization (WHO) criteria, treated with basal insulin - HbA1c 8-11% inclusive - Glomerular filtration rate (GFR) > 60 ml/min - Has an Android or iOS based compatible smartphone (iOS 9.0 or above, Android 4.4 or above) - Willing to perform at least 1 fasting finger stick glucose measurements every morning - English speaking

Exclusion Criteria

Diagnosis of hypoglycemic unawareness - Diagnosis of hyperglycemic hyperosmolar non-ketotic coma (HONK) or diabetic ketoacidosis (DKA) within 6 months of enrollment - Recent (within the last 6 months)/current use of non-topical steroids - Insulin requirements in excess of 1 U/kg per day - Use of pioglitazone or another thiazolidinedione (TZD) - In the opinion of the provider, HgbA1c goals should be adjusted above 7% due to infirmity, unstable cardiovascular disease, etc.

Study Design

Phase: N/A
Study Type: Interventional
Allocation: Randomized
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
Masking: None (Open Label)

Arm Groups

Arm	Description	Assigned Intervention
Experimental iSage for adjustment of insulin	The provider will prescribe the iSage app to the subject and choose a treatment algorithm within the app to make insulin dose adjustments.	Other: iSage The provider will choose a treatment algorithm within the iSage app and set the parameters to make insulin dose adjustments no less frequently than every 7 days. The patient is instructed to perform daily fasting glucose measurements and follow the app's recommendations for insulin adjustment.
No Intervention Conventional management	Our clinic uses a modified treat-to-target algorithm which is summarized on a 3 x 5 refrigerator magnet.

More Details

Status: Completed
Sponsor: University of Kansas Medical Center

Study Contact

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.