- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02956642
Study to Understand Gaining Access to Blood Glucose Records (SUGAR)
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
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Participants in this study will partake in study surveys, daily blood glucose monitor measurements, and blood sampling for the duration of their participation. The study intends to recruit and randomize 300 participants.
Surveys and Measurements
All study participants may complete surveys via their personal iOS smartphone device on: study qualification (intake survey/eligibility screener), diabetes status (initial diabetes survey), physical activity (iPAQ), quality of life (SF-12), vitals, demographics hospitalizations and interaction with health care provider (attached), and diabetes distress. Most survey data will be collected at 1, 3, and 6 months. There will also be Weekly Engagement surveys which will be two simple questions each week. At the end of the study, a Feedback survey will ask participants about their study experiences. Surveys will each have a simple description to introduce participants to the survey they are being asked to take. These surveys will be administered through the Eureka mHealth Research Platform, the study's main tool for data collection, data storage, and study management. Specific usability assessments that are native to the Livongo or iHealth platform may also be shown through the device to the participants in order to gather user feedback information.
After qualifying and providing consent to participate in the study, participants will be referred to a convenient lab or receive a mail-in lab test kit for establishing hemoglobin A1c (A1c) levels and lipid panel levels. A1c tests will be collected at months 1 (baseline), 3, and 6 (closeout). For each A1c test performed in the lab, 1mL (milliliter) of blood will be drawn. Lipid panels (total cholesterol, LDL, HDL, and triglycerides) will be collected at months 1 (baseline) and 6 (closeout). For each lipid panel, 1mL of blood will be drawn. If participants elect to use a mail-in lab test kit, for each A1c test or lipid panel, 35 microliters of blood will be collected and mailed in for testing (total 75 microliters at months 1 and 6, and 30 microliters at month 3).
- Randomization Once the baseline A1c value is obtained, the patient will be randomized (block randomization by diabetes type).
Device Usage After randomization, participants will receive either the Livongo Health system or the iHealth glucose meter by mail.
If a participant is randomized to the iHealth treatment group, participants will download the iHealth iOS application and receive an iHealth blood glucose meter in the mail. Participants will link the iHealth application with a mobile version of the Eureka mHealth Research Platform.
If a participant is randomized to the Livongo system treatment group, the participant will receive the Livongo blood glucose meter device in the mail, create a Livongo account, and link their Livongo account with the Eureka mHealth Research Platform. Livongo- or iHealth-specific instructions will be provided with each meter and a study coordinator will be available to answer study participant questions about using the BG meters. Participants may be referred to Livongo or iHealth customer service for technical support, if needed.
Participants will not be given specific instructions on how often to check their BG, or how often they should use the Livongo system or iHealth glucose meter as a part of this study. This is done in order to determine the uptake of the intervention and resulting behavior without outside prompting.
Participants will either use the Livongo system or the iHealth glucose meter for 6 months from the time of enrollment in the study.
- Messaging/Reminders Participants who have been mailed a BG (Blood Glucose) meter but are not using the device after two weeks will be contacted by in-app push notifications, text messages, email or a phone call for device setup and/or assistance.
Participants will also receive reminders to complete study activities via in-app push notifications, text messages, email or a phone call.
Two weeks prior to the end of the study period, participants will be contacted by email and/or receive in-app push notifications to remind them to complete their A1c measurement and closeout surveys.
Note: Participation in this research study will not affect individual participants' standard clinical care for diabetes. Participants will remain under the care of their current health care provider and will be able to continue receiving all usual care from that provider. The health care provider will continue to provide recommendations for the number of times the participant should check their blood glucose. Although the participant wil be asked to use a different glucose meter for this study, the number of times they use it will still be determined by their health care provider. The same information that they received from their existing glucose meter will be available from the study glucose meter. During the study, they will be provided with glucose meter strips at no charge, to ensure that an insufficient number of strips will not interfere with their standard of care.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
California
-
San Francisco, California, United States, 94158
- University of California, San Francisco
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / 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.
|
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.
|
Participants will be asked to use the iHealth Glucose Meter to take blood glucose measurements.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
6 months
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Jenise Wong, MD, PhD, University of California, San Francisco
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- Eur-001
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Diabetes Mellitus
-
University of Colorado, DenverMassachusetts General Hospital; Beta Bionics, Inc.CompletedDiabetes Mellitus, Type 1 | Type 1 Diabetes | Diabetes type1 | Type 1 Diabetes Mellitus | Autoimmune Diabetes | Diabetes Mellitus, Insulin-Dependent | Juvenile-Onset Diabetes | Diabetes, Autoimmune | Insulin-Dependent Diabetes Mellitus 1 | Diabetes Mellitus, Insulin-Dependent, 1 | Diabetes Mellitus, Brittle | Diabetes Mellitus, Juvenile-Onset and other conditionsUnited States
-
Guang NingRecruitingType 2 Diabetes Mellitus | Type1 Diabetes Mellitus | Monogenetic Diabetes | Pancreatogenic Diabetes | Drug-Induced Diabetes Mellitus | Other Forms of Diabetes MellitusChina
-
Meir Medical CenterCompletedDiabetes Mellitus Type 2 | Diabetes Mellitus, Non-insulin Dependant | Diabetes Mellitus, on Oral Hypoglycemic Treatment | Adult Type Diabetes MellitusIsrael
-
Medical College of WisconsinMedical University of South CarolinaCompletedDiabetes Mellitus | Type 2 Diabetes Mellitus | Adult-Onset Diabetes Mellitus | Non-Insulin-Dependent Diabetes Mellitus | Noninsulin Dependent Diabetes Mellitus, Type IIUnited States
-
Hanmi Pharmaceutical Company LimitedUnknownType2 Diabetes Mellitus | Type1 Diabetes MellitusUnited States
-
Peking Union Medical College HospitalUnknownType 2 Diabetes Mellitus | Type 1 Diabetes Mellitus | Gestational Diabetes Mellitus | Pancreatogenic Diabetes Mellitus | Pregestational Diabetes Mellitus | Diabetes Patients in Perioperative PeriodChina
-
SanofiCompletedType 1 Diabetes Mellitus-Type 2 Diabetes MellitusHungary, Russian Federation, Germany, Poland, Japan, United States, Finland
-
Joslin Diabetes CenterCambridge Medical Technologies, LLCCompletedType 2 Diabetes Mellitus | Type1 Diabetes MellitusUnited States
-
Medical College of WisconsinMedical University of South Carolina; National Institute of Diabetes and Digestive...Active, not recruitingDiabetes Mellitus, Type 2 | Diabetes Mellitus, Type II | Diabetes Mellitus, Adult-Onset | Diabetes Mellitus, Non-Insulin-Dependent | Diabetes Mellitus, Noninsulin DependentUnited States
-
Medical College of WisconsinNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)CompletedDiabetes Mellitus, Type 2 | Diabetes Mellitus, Type II | Diabetes Mellitus, Adult-Onset | Diabetes Mellitus, Non-Insulin-Dependent | Diabetes Mellitus, Noninsulin DependentUnited States
Clinical Trials on Livongo Health System
-
University of Massachusetts, WorcesterLivongo HealthCompletedDiabetes Mellitus, Type 2
-
Livongo HealthEvidation Health; VoluntisTerminatedType 2 Diabetes Treated With InsulinUnited States
-
International Food Policy Research InstituteFHI 360; Addis Continental Institute of Public HealthCompletedMaternal Dietary Diversity | Iron-Folic Acid Supplementation | Early Initiation of BreastfeedingUnited States
-
May HealthRecruitingThe REBALANCE Study - a Prospective, Multicenter, Randomized, Pivotal Study of the May Health SystemPolycystic Ovary Syndrome | Infertility, FemaleUnited States
-
Indiana UniversityNational Institute on Drug Abuse (NIDA)Enrolling by invitationSubstance-Related Disorders | Opioid-Related Disorders | Substance Use | Recidivism | Criminal BehaviorUnited States
-
Massachusetts General HospitalBoston University; National Institute of Mental Health (NIMH); National Institutes... and other collaboratorsCompleted
-
University of OttawaCompleted
-
Reciprocal LabsCalifornia HealthCare FoundationCompleted
-
University of PennsylvaniaCompleted
-
University of California, San DiegoNational Institute of Mental Health (NIMH); Gilead Sciences; Proteus Digital...Active, not recruiting