mHealth Insulin Titration and Management (iSage)

NCT03704103 | Completed

• 1 other identifier: STUDY00142758
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

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.

Conditions

Type 2 Diabetes Mellitus

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• Sustained use of the iSage app (iSage group only)

  90 days

• Hypoglycemia

  90 days

Other Outcomes (4)

• Healthcare resource utilization

  90 days

• Diabetes Quality of Life Survey (DQOL)

  90 days

• Insulin Treatment Satisfaction Questionnaire (ITSQ)

  90 days

Study Arms (2)

iSage for adjustment of insulin

EXPERIMENTAL

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

Conventional management

NO INTERVENTION

Our clinic uses a modified treat-to-target algorithm which is summarized on a 3 x 5 refrigerator magnet.

Interventions

iSage OTHER

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.

iSage for adjustment of insulin

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Kansas Medical Center: lead

Study Sites (1)

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 28, 2018
• First Posted: October 12, 2018
• Study Start: August 28, 2018
• Primary Completion: August 4, 2023
• Study Completion: August 4, 2023
• Last Updated: August 8, 2023

Record last verified: 2023-08

Locations

US (1)