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

Sponsor

Livongo Health (Industry)

Overall Status

Terminated

CT.gov ID

NCT03980236

Collaborator

Voluntis (Industry), Evidation Health (Industry)

Enrollment

Location

Arm

12.8

Actual Duration (Months)

1.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Type 2 Diabetes Treated With Insulin	Device: Livongo-Insulia Study App	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

21 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Health Services Research

Official Title:

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

Actual Study Start Date :

May 6, 2019

Actual Primary Completion Date :

Feb 27, 2020

Actual Study Completion Date :

May 31, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Livongo-Insulia Study App Arm Participants will be asked to use the Livong-Insulia Study App for the 3 month study duration	Device: Livongo-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.

Arm

Intervention/Treatment

Experimental: Livongo-Insulia Study App Arm

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

Device: Livongo-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.

Outcome Measures

Primary Outcome Measures

Change in A1c [12 weeks]
Change in A1c from baseline to 12 weeks

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Livongo	Mountain View	California	United States	94041

Sponsors and Collaborators

Livongo Health
Voluntis
Evidation Health

Investigators

Principal Investigator: Bimal Shah, MD, MBA, Livongo Health

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Bimal Shah, MD, Co-Principal Investigator, Livongo Health

ClinicalTrials.gov Identifier:

NCT03980236

Other Study ID Numbers:

CP04573.A

First Posted:

Jun 10, 2019

Last Update Posted:

Feb 18, 2021

Last Verified:

Feb 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Yes

Additional relevant MeSH terms:

Diabetes Mellitus

Diabetes Mellitus, Type 2

Study Results

No Results Posted as of Feb 18, 2021