Study to Understand Gaining Access to Blood Glucose Records (SUGAR)
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|ClinicalTrials.gov Identifier: NCT02956642|
Recruitment Status : Recruiting
First Posted : November 7, 2016
Last Update Posted : November 16, 2018
|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|
|Intervention Model:||Parallel Assignment|
|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|
|Actual Study Start Date :||November 14, 2018|
|Estimated Primary Completion Date :||November 2019|
|Estimated Study Completion Date :||December 2019|
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.
- 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.
- 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.
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
|Contact: Xochitl Butcherfirstname.lastname@example.org|
|United States, California|
|University of California, San Francisco||Recruiting|
|San Francisco, California, United States, 94158|
|Contact: Xochitl Butcher 415-502-3147 email@example.com|
|Principal Investigator: Jenise Wong, MD, PhD|
|Principal Investigator:||Jenise Wong, MD, PhD||University of California, San Francisco|