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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03980236
Recruitment Status : Terminated (Did not achieve enrollment goal)
First Posted : June 10, 2019
Last Update Posted : February 18, 2021
Evidation Health
Information provided by (Responsible Party):
Bimal Shah, MD, Livongo Health

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 Not Applicable

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Study Type : Interventional  (Clinical Trial)
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 : February 27, 2020
Actual Study Completion Date : May 31, 2020

Resource links provided by the National Library of Medicine

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.

Primary Outcome Measures :
  1. Change in A1c [ Time Frame: 12 weeks ]
    Change in A1c from baseline to 12 weeks

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03980236

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United States, California
Mountain View, California, United States, 94041
Sponsors and Collaborators
Livongo Health
Evidation Health
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Principal Investigator: Bimal Shah, MD, MBA Livongo Health
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Responsible Party: Bimal Shah, MD, Co-Principal Investigator, Livongo Health Identifier: NCT03980236    
Other Study ID Numbers: CP04573.A
First Posted: June 10, 2019    Key Record Dates
Last Update Posted: February 18, 2021
Last Verified: February 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases