Feasibility of Using the Livongo-Insulia Study App for Patients With Type 2 Diabetes [Pilot Study]

Study Overview
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Brief Summary
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The Livongo-Insulia Study App Pilot Study (LISA Pilot) is a 3-month, prospective, interventional study. The purpose of this pilot study is to evaluate the feasibility of using the Livongo-Insulia Study App for individuals with type 2 diabetes using basal insulin. This will be assessed by measuring the impact of the Livongo-Insulia Study App on glycemic control for these individuals.

Official Title
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Feasibility of Using the Insulia App in an Integrated Platform With Livongo for Patients With Type 2 Diabetes Treated With Basal Insulin [Pilot Study]

Conditions
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Type 2 Diabetes Treated With Insulin

Intervention / Treatment
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* Device: Livongo-Insulia Study App


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≥ 18 years Lives in the U.S. Able to speak, read and write in English Diagnosed with type 2 diabetes Currently treated with long-acting basal insulin analog (Lantus, Levemir, Toujeo, Basaglar, Tresiba U-100) and taking 1 injection per day Takes a daily dose ≤ 0.75 units/kg Estimated A1c ≥ 8% (based on existing Livongo data) Has been enrolled in Livongo for at least 12 weeks Uses an iPhone compatible with Insulia's compatibility matrix (iPhone 5 or higher; iOS 8 or newer) Willing to complete study questionnaires Willing to complete at-home A1c kits Willing to check before breakfast blood glucose at least once per day Exclusion Criteria: Diagnosis of type 1 diabetes Currently using a long-acting basal insulin analog that is not supported by Insulia Currently using rapid-acting, short-acting, or intermediate-acting or premixed insulins Currently pregnant or planning pregnancy

Ages Eligible for Study
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Minimum Age: 18 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: Health Services Research
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Livongo-Insulia Study App Arm<br>Participants will be asked to use the Livong-Insulia Study App for the 3 month study duration | Device: Livongo-Insulia Study App<br>* Throughout the study, participants will be asked to use the LIvongo-Insulia Study App daily to receive their basal insulin dose recommendation. Participants will need to check their before breakfast blood glucose using their Livongo meter. Then, they will need to open the Livongo-Insulia Study App and accept the uploaded blood glucose(s) from the Livongo meter. Once the appropriate information is received, participants will receive an insulin dose recommendation and should confirm once the dose has been taken. Depending on their blood glucose, participants may also receive coaching messages and coaching support from the Livongo program.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in A1c | Change in A1c from baseline to 12 weeks | 12 weeks |