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

L

Livongo Health

Status

Terminated

Conditions

Type 2 Diabetes Treated With Insulin

Treatments

Device: Livongo-Insulia Study App

Study type

Interventional

Funder types

Industry

Identifiers

NCT03980236
CP04573.A

Details and patient eligibility

About

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.

Enrollment

21 patients

Sex

All

Ages

18+ years old

Volunteers

No 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

Trial design

Primary purpose

Health Services Research

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

21 participants in 1 patient group

Livongo-Insulia Study App Arm
Experimental group
Description:
Participants will be asked to use the Livong-Insulia Study App for the 3 month study duration
Treatment:
Device: Livongo-Insulia Study App

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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