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

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ClinicalTrials.gov Identifier: NCT03980236
Recruitment Status : Recruiting
First Posted : June 10, 2019
Last Update Posted : June 10, 2019
Sponsor:
Collaborators:
Voluntis
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)
Estimated Enrollment : 60 participants
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
Estimated Primary Completion Date : November 2019
Estimated Study Completion Date : November 2019

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

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

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 ClinicalTrials.gov identifier (NCT number): NCT03980236


Contacts
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Contact: Bimal Shah, MD, MBA 866-435-5643 bshah@livongo.com
Contact: Ellie Strock, ANP-BC 617-245-4123 ellie.strock@voluntis.com

Locations
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United States, California
Livongo Recruiting
Mountain View, California, United States, 94041
Sponsors and Collaborators
Livongo Health
Voluntis
Evidation Health
Investigators
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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
ClinicalTrials.gov Identifier: NCT03980236     History of Changes
Other Study ID Numbers: CP04573.A
First Posted: June 10, 2019    Key Record Dates
Last Update Posted: June 10, 2019
Last Verified: June 2019
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
Pediatric Postmarket Surveillance of a Device Product: No
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs