mHealth Insulin Titration and Management (iSage)

Not Applicable

Completed

• Conditions: Type 2 Diabetes Mellitus
• Interventions: Other: iSage

• Registration Number: NCT03704103
• Lead Sponsor: University of Kansas Medical Center

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-08-28
• Study First Submitted: 2018-08-28
• Study First Submitted QC: 2018-10-09
• Study First Posted: 2018-10-12
• Status Verified: 2023-08
• Primary Completion: 2023-08-04
• Study Completion: 2023-08-04
• Last Update Submitted: 2023-08-04
• Last Update Posted: 2023-08-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 6

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
iSage for adjustment of insulin	iSage	The provider will prescribe the iSage app to the subject and choose a treatment algorithm within the app to make insulin dose adjustments.

Primary Outcome Measures

Name	Time	Method
Number of participants meeting HgbA1c <7%	90 days	The investigators will calculate the percent of patients achieving HgbA1c \<7% at day 90.
Concentration of HgbA1c	90 days	The investigators will compare changes in HgbA1c from baseline to day 90.

Secondary Outcome Measures

Name	Time	Method
Sustained use of the iSage app (iSage group only)	90 days	The investigators will compare the percentage of subjects using the app as prescribed versus "dropouts".
Hypoglycemia	90 days	The investigators will record the number of episodes of hypoglycemia, to include severity of event, related symptoms, and time of day.

Trial Locations

Locations (1)

University of Kansas Medical Center; 🇺🇸 Kansas City, Kansas, United States