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

NCT03980236 | Terminated FDA Device

• 1 other identifier: CP04573.A
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

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.

Conditions

Type 2 Diabetes Treated With Insulin

Outcome Measures

Primary Outcomes (1)

• Change in A1c

  Change in A1c from baseline to 12 weeks

  12 weeks

Study Arms (1)

Livongo-Insulia Study App Arm

EXPERIMENTAL

Participants will be asked to use the Livong-Insulia Study App for the 3 month study duration

Device: Livongo-Insulia Study App

Interventions

Livongo-Insulia Study App DEVICE

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.

Livongo-Insulia Study App Arm

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Livongo Health: lead
• Voluntis: collaborator
• Evidation Health: collaborator

Study Sites (1)

Livongo

Mountain View, California, 94041, United States

Location

Study Officials

• Bimal Shah, MD, MBA

  Livongo Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Co-Principal Investigator

Study Record Dates

• First Submitted: June 4, 2019
• First Posted: June 10, 2019
• Study Start: May 6, 2019
• Primary Completion: February 27, 2020
• Study Completion: May 31, 2020
• Last Updated: February 18, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)