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

Primary Purpose

Type 2 Diabetes Treated With Insulin

Status

Terminated

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Livongo-Insulia Study App

About this trial

This is an interventional health services research trial for Type 2 Diabetes Treated With Insulin

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Livongo

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Livongo-Insulia Study App Arm

Arm Description

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

Outcomes

Primary Outcome Measures

Change in A1c

Change in A1c from baseline to 12 weeks

Secondary Outcome Measures

Full Information

NCT ID

NCT03980236

First Posted

June 4, 2019

Last Updated

February 16, 2021

Sponsor

Livongo Health

Collaborators

Voluntis, Evidation Health

1. Study Identification

Unique Protocol Identification Number

NCT03980236

Brief Title

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

Acronym

LISA Pilot

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]

Study Type

Interventional

2. Study Status

Record Verification Date

February 2021

Overall Recruitment Status

Terminated

Why Stopped

Did not achieve enrollment goal

Study Start Date

May 6, 2019 (Actual)

Primary Completion Date

February 27, 2020 (Actual)

Study Completion Date

May 31, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Livongo Health

Collaborators

Voluntis, Evidation Health

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Device Product Not Approved or Cleared by U.S. FDA

Yes

Data Monitoring Committee

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Type 2 Diabetes Treated With Insulin

7. Study Design

Primary Purpose

Health Services Research

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

21 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Livongo-Insulia Study App Arm

Arm Type

Experimental

Arm Description

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

Intervention Type

Device

Intervention Name(s)

Livongo-Insulia Study App

Intervention Description

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.

Primary Outcome Measure Information:

Title

Change in A1c

Description

Change in A1c from baseline to 12 weeks

Time Frame

12 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Bimal Shah, MD, MBA

Organizational Affiliation

Livongo Health

Official's Role

Principal Investigator

Facility Information:

Facility Name

Livongo

City

Mountain View

State/Province

California

ZIP/Postal Code

94041

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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