mHealth Insulin Titration and Management (iSage)

Type 2 Diabetes Mellitus Clinical Trial

Official title:

mHealth Insulin Titration and Management (iSage)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03704103
• Other study ID #: STUDY00142758
• Status: Completed
• Phase: N/A
• Start date: August 28, 2018
• Est. completion date: August 4, 2023

Study information

• Verified date: August 2023
• Source: University of Kansas Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6
• Est. completion date: August 4, 2023
• Est. primary completion date: August 4, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Type 2 Diabetes Mellitus

Intervention

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.

Locations

Country	Name	City	State
United States	University of Kansas Medical Center	Kansas City	Kansas

Sponsors (1)

Lead Sponsor	Collaborator
University of Kansas Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Healthcare resource utilization	Number of contacts with healthcare resources (including telephone calls), ER visits, clinic visits, hospitalizations	90 days
Other	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
Other	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
Other	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
Primary	Concentration of HgbA1c	The investigators will compare changes in HgbA1c from baseline to day 90.	90 days
Primary	Number of participants meeting HgbA1c <7%	The investigators will calculate the percent of patients achieving HgbA1c <7% at day 90.	90 days
Secondary	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
Secondary	Hypoglycemia	The investigators will record the number of episodes of hypoglycemia, to include severity of event, related symptoms, and time of day.	90 days