Continuous Glucose Monitors to Regulate Glucose Levels in Type 2 Diabetics - (Protocol 3) (CGM_IRB-3)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03290768|
Recruitment Status : Active, not recruiting
First Posted : September 25, 2017
Last Update Posted : September 24, 2018
|Condition or disease||Intervention/treatment||Phase|
|Type2 Diabetes||Device: Continuous Glucose Monitor (CGM) Device: Activity Tracker Behavioral: Coaching||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||356 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|Official Title:||Empowering Medicare Patients to Self-Manage Their Type 2 Diabetes Using Continuous Glucose Monitoring (CGM) - Investigational Device Pilot (SMA Investigational Device)|
|Actual Study Start Date :||September 13, 2017|
|Estimated Primary Completion Date :||August 23, 2019|
|Estimated Study Completion Date :||December 2027|
Experimental: Diabetes Management Educational Program
Subjects receive a CGM and activity tracker as part of a educational program to help manage their glucose levels.
Device: Continuous Glucose Monitor (CGM)
Subjects will use a CGM to develop an understanding of how their behaviors influence their glucose levels.
Other Name: Dexcom Investigational Use Only (IUO) Device
Device: Activity Tracker
Subjects will use the activity tracker, in combination with a continuous glucose monitor (CGM), to develop an understanding of how their activity levels affect their glucose levels.
Other Name: Fitbit Charge 2
Coaches will help subjects understand the readings from the CGMs and how they are affected by diet choices, use of diabetes medications, etc. Coaches and subjects will have weekly conversations about CGM data and behaviors that affect CGM readings. Coaching will occur via telephone, text messaging, and automated text messaging.
- Program Enrollment Rate (%) [ Time Frame: up to three months ](Number of patients who were shipped devices) / (Number of patients invited to enroll)
- Program Completion Rate (%) [ Time Frame: up to 11 months ](Number of patients who complete 10 weeks of CGM) / (Number of patients who received devices)
- Weekly Average of Estimated Glucose Values (EGV) (Average) [ Time Frame: up to 10 weeks ](Sum of EGV for one week) / (Total number of EGV)
- Change in Medication Dosage (mg/day; U/day) [ Time Frame: up to 11 months ](dosage of Rx on Day 180) - (dosage of Rx on Day 0)
- Average Age of Participants Who Start Trial (yrs) [ Time Frame: up to three months ](Sum of ages of all enrollees) / (Total number of enrollees)
- Average Age of Participants Who Complete Trial (yrs) [ Time Frame: up to 11 months ](Sum of age of patients who complete) / (Total number who complete)
- Texting with Coaches [ Time Frame: up to 10 weeks ](Sum of all text messages) / (Total number of days)
- Coaching Participation Rate [ Time Frame: up to 10 weeks ](Sum of weekly coaching calls completed) / (Total number of weeks)
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): NCT03290768
|United States, Nevada|
|Southwest Medical Associates|
|Las Vegas, Nevada, United States, 89102|