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Study to Understand Gaining Access to Blood Glucose Records (SUGAR)

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ClinicalTrials.gov Identifier: NCT02956642
Recruitment Status : Not yet recruiting
First Posted : November 7, 2016
Last Update Posted : May 9, 2018
Sponsor:
Collaborator:
Livongo Health, Inc.
Information provided by (Responsible Party):
Jenise Wong, University of California, San Francisco

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.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus Device: Livongo Health System Device: iHealth Glucose Meter Phase 2

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Study to Understand Gaining Access to Blood Glucose Records (SUGAR), A Randomized Controlled Trial of the Effect of the Livongo Health Diabetes Management Program vs. Standard Care on Glycemic Control
Estimated Study Start Date : May 2018
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Blood Sugar
Drug Information available for: Dextrose

Arm Intervention/treatment
Experimental: Blood Glucose Monitoring System
Participants in this arm will receive the Livongo Health System to manage diabetes. 150 participants will participate in this arm.
Device: Livongo Health System
Participants will be asked to use the Livongo Health System to manage their blood glucose.

Active Comparator: Standard Blood Glucose Monitoring
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
Participants will be asked to use the iHealth Glucose Meter to take blood glucose measurements.




Primary Outcome Measures :
  1. Change in HbA1c Levels [ Time Frame: 6 months ]
    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.


Secondary Outcome Measures :
  1. Change in fasting lipid panel. [ Time Frame: 6 months ]
    As a secondary outcome, we will determine the effect of use of the Livongo Health system on fasting lipid panels. A lipid panel will be done at baseline and at 6 months.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

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): NCT02956642


Contacts
Contact: Xochitl Butcher 415-502-3147 xochitl.butcher@ucsf.edu

Locations
United States, California
University of California, San Francisco Not yet recruiting
San Francisco, California, United States, 94158
Contact: Xochitl Butcher    415-502-3147    xochitl.butcher@ucsf.edu   
Principal Investigator: Jenise Wong, MD, PhD         
Sponsors and Collaborators
University of California, San Francisco
Livongo Health, Inc.
Investigators
Principal Investigator: Jenise Wong, MD, PhD University of California, San Francisco

Responsible Party: Jenise Wong, MD, PhD; Assistant Professor of Pediatrics, Division of Endocrinology, University of California, San Francisco
ClinicalTrials.gov Identifier: NCT02956642     History of Changes
Other Study ID Numbers: EUR-001
First Posted: November 7, 2016    Key Record Dates
Last Update Posted: May 9, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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: No
Product Manufactured in and Exported from the U.S.: No

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