mHealth Insulin Titration and Management (iSage)

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.

Study Overview

• Status: Completed
• Conditions: Type 2 Diabetes Mellitus
• Intervention / Treatment: Other: iSage

• Study Type: Interventional
• Enrollment (Actual): 6
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Michelle Vitztum, MPH; Phone Number: 913-588-1045; Email: mvitztum@kumc.edu

Study Locations

• United States
  • Kansas
    • Kansas City, Kansas, United States, 66160
      • University of Kansas Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Healthcare resource utilization	Number of contacts with healthcare resources (including telephone calls), ER visits, clinic visits, hospitalizations	90 days
Diabetes Quality of Life Survey (DQOL)	The investigators will compare DQOL scores from baseline to day 90. The 15-item DQOL Brief Clinical Inventory provides a total health-related quality of life score that predicts self-reported diabetes care behaviors and satisfaction with diabetes control as effectively as the full version of the instrument. Items are scored on a 5-point Likert scale and are of two general formats. One format asks about the frequency of negative impact of diabetes itself or of the diabetes treatment (i.e., "How often do you worry about whether you will pass out?") and provides response options from 1 (never) to 5 (all the time). The second format asks about satisfaction with treatment and quality of life (i.e., "How satisfied are you with the time you spend exercising?") and is scored from 1 (very satisfied) to 5 (very dissatisfied). Higher scores are negatively valanced, indicating problem frequency or dissatisfaction.	90 days
Insulin Treatment Satisfaction Questionnaire (ITSQ)	The investigators will compare ITSQ scores from baseline to day 90. The 22-item ITSQ is applicable to a wide variety of insulin therapies, and measures insulin treatment satisfaction assessing regimen inconvenience, lifestyle flexibility, glycemic control, hypoglycemic control, and satisfaction with the insulin delivery device. The response scale is ordinal, ranging from 1 (extremely satisfied) to 6 (extremely dissatisfied). The ITSQ is scored among 5 content clusters, forming a total ITSQ score between 0% to 100%, where 100% indicates complete satisfaction with insulin treatment.	90 days
iSage Product Satisfaction Survey (iSage group only)	The investigators will assess iSage app ease of use and satisfaction. Survey consists of 3 items. Answer choices range from 1 (strongly disagree) to 5 (strongly agree).	90 days

Collaborators and Investigators

• Sponsor: University of Kansas Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): August 28, 2018
• Primary Completion (Actual): August 4, 2023
• Study Completion (Actual): August 4, 2023

Study Registration Dates

• First Submitted: August 28, 2018
• First Submitted That Met QC Criteria: October 9, 2018
• First Posted (Actual): October 12, 2018

Study Record Updates

• Last Update Posted (Actual): August 8, 2023
• Last Update Submitted That Met QC Criteria: August 4, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2
• Other Study ID Numbers: STUDY00142758

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No