NCT02956642

Brief Summary

This study is a two-arm randomized controlled trial in which participants will receive either the Livongo Health system or iHealth glucose meter for measuring their blood glucose. The study hypothesizes the use of the Livongo Health system results in a greater improvement in A1c compared to standard blood glucose monitoring, as demonstrated by the iHealth Bluetooth-enabled glucose meter.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
84

participants targeted

Target at P25-P50 for not_applicable diabetes-mellitus

Timeline
Completed

Started Nov 2018

Typical duration for not_applicable diabetes-mellitus

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 31, 2016

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 7, 2016

Completed
2 years until next milestone

Study Start

First participant enrolled

November 14, 2018

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 17, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 17, 2021

Completed
4.3 years until next milestone

Results Posted

Study results publicly available

April 30, 2025

Completed
Last Updated

April 30, 2025

Status Verified

April 1, 2025

Enrollment Period

2.2 years

First QC Date

October 31, 2016

Results QC Date

January 28, 2025

Last Update Submit

April 11, 2025

Conditions

Diabetes Mellitus

Outcome Measures

Primary Outcomes (2)

  • Mean HbA1c Levels

    Three HbA1c measures per study participant will be acquired at 3 points in the study duration (baseline, 3 months, and 6 months). In order to compare the changes in HbA1c, the values may be analyzed and separated with regard to duration of diabetes (days, months, years), and/or HbA1c levels at baseline. Reported in this table are the means for all participants for each given timepoint.

    6 months

  • Change in HbA1c

    In this analysis, change in HbA1c within individual participants was compared from baseline to 6 months. Only participants with 6-month data were included.

    6 months

Secondary Outcomes (2)

  • Mean Fasting LDL

    6 months

  • Change in Fasting LDL

    6 months

Study Arms (2)

Blood Glucose Monitoring System

EXPERIMENTAL

Participants in this arm will receive the Livongo Health System to manage diabetes. 150 participants will participate in this arm.

Device: Livongo Health System

Standard Blood Glucose Monitoring

ACTIVE COMPARATOR

Participants in this arm will receive the iHealth Glucose Meter to take blood glucose measurements that will then be compared to participants from the Livongo Health System arm. 150 participants will participate in this arm.

Device: iHealth Glucose Meter

Interventions

Livongo Health SystemDEVICE

Participants will be asked to use the Livongo Health System to manage their blood glucose.

Blood Glucose Monitoring System
iHealth Glucose MeterDEVICE

Participants will be asked to use the iHealth Glucose Meter to take blood glucose measurements.

Standard Blood Glucose Monitoring

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • People with type 2 diabetes mellitus on any type of medication
  • Adults, age 18 years or older
  • iOS Smartphone with access to data and/or Wi-Fi
  • Willing to answer survey questions throughout the study
  • Willing to visit a lab for 3 blood draws at no cost to participants

You may not qualify if:

  • Using continuous glucose monitoring during the study period
  • Using an insulin pump during the study period
  • Unable or unwilling to switch blood glucose meters to the study meter
  • Hospitalization for Diabetic ketoacidosis (DKA) or hypoglycemia in the past 1 month prior to enrollment
  • Pregnant patients, or intention to become pregnant during the study period

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of California, San Francisco

San Francisco, California, 94158, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Results Point of Contact

Title
Dr. Jenise Wong
Organization
University of California San Francisco
jenise.wong@ucsf.edu
415-476-3316

Study Officials

  • Jenise Wong, MD, PhD

    University of California, San Francisco

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 31, 2016

First Posted

November 7, 2016

Study Start

November 14, 2018

Primary Completion

January 17, 2021

Study Completion

January 17, 2021

Last Updated

April 30, 2025

Results First Posted

April 30, 2025

Record last verified: 2025-04

Data Sharing

IPD Sharing
Will not share

Locations

US(1)