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
Sponsored by
About this trial
This is an interventional health services research trial for Type 2 Diabetes Treated With Insulin
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
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
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Data Monitoring Committee
No
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
No
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
No
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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