mHealth Insulin Titration and Management (iSage)

Study Overview
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Brief Summary
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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.

Official Title
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mHealth Insulin Titration and Management (iSage)

Conditions
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Type 2 Diabetes Mellitus

Intervention / Treatment
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* Other: iSage


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: iSage for adjustment of insulin<br>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<br>* 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.<br>|
| No Intervention: Conventional management<br>Our clinic uses a modified treat-to-target algorithm which is summarized on a 3 x 5 refrigerator magnet. | |

What is the study measuring?
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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 |