Feasibility of Using the Livongo-Insulia Study App for Patients With Type 2 Diabetes [Pilot Study]
NCT ID: NCT03980236
Last Updated: 2021-02-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
NA
21 participants
INTERVENTIONAL
2019-05-06
2020-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
HEALTH_SERVICES_RESEARCH
NONE
Study Groups
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Livongo-Insulia Study App Arm
Participants will be asked to use the Livong-Insulia Study App for the 3 month study duration
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Voluntis
INDUSTRY
Evidation Health
INDUSTRY
Livongo Health
INDUSTRY
Responsible Party
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Bimal Shah, MD
Co-Principal Investigator
Principal Investigators
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Bimal Shah, MD, MBA
Role: PRINCIPAL_INVESTIGATOR
Livongo Health
Locations
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Livongo
Mountain View, California, United States
Countries
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Other Identifiers
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CP04573.A
Identifier Type: -
Identifier Source: org_study_id
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