Type 2 Diabetes Treated With Insulin
Conditions
Brief summary
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.
Interventions
DEVICELivongo-Insulia Study App
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.
Sponsors
Voluntis
Evidation Health
Livongo Health
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in A1c | 12 weeks | Change in A1c from baseline to 12 weeks |
Countries
United States
Outcome results
None listed