Continuous Glucose Monitors to Regulate Glucose Levels in Type 2 Diabetics

Type2 Diabetes Clinical Trial

— CGM_IRB2  

Official title:

Empowering Medicare Patients to Self-Manage Their Type 2 Diabetes Using Continuous Glucose Monitoring (CGM) - Investigational Device Pilot

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03252964
• Other study ID #: Pro00021722
• Status: Completed
• Phase: N/A
• Start date: July 28, 2017
• Est. completion date: February 25, 2019

Study information

• Verified date: May 2019
• Source: Savvysherpa, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study allows Type 2 diabetics to receive feedback from a continuous glucose monitor (CGM) as part of an educational program designed to help them better manage their glucose levels. Subjects will also wear an activity tracker to monitor their activity and observe its effect on their glucose levels. The educational program will involve calls from coaches to check subjects' progress and answer questions.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 52
• Est. completion date: February 25, 2019
• Est. primary completion date: May 23, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

Inclusion Criteria:

• Be diagnosed with type 2 diabetes

• Currently take a DPP4 inhibitor, SGLT2 inhibitor, GLP-1 agonist, and/or basal insulin

• Be able to read and understand English

• Have access to a telephone

• Have a Medicare health plan

Exclusion Criteria:

• Pregnant

• Blind

• Deaf

• Currently receiving chemotherapy or radiation therapy to treat cancer

• Addicted to any drugs (including alcohol, painkillers, hallucinogens, or others)

• Critically ill

• Diagnosed with or experiencing:

• Kidney disease stages 4 and 5

• End stage renal disease

• Severe liver disease

• Dementia

• Schizophrenia

• Bipolar disorder

• Autism

• An intellectual or learning disability

• Arrhythmias other than atrial fibrillation

• Congestive heart failure

• Has had a:

• Myocardial infarction within the last 6 months

• Stroke within the last 6 months

• Stroke that resulted in significant disability (e.g., unable to write clearly or walk)

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Type2 Diabetes

Intervention

Device:
• Continuous Glucose Monitor (CGM)
Subjects will use a CGM to develop an understanding of how their behaviors influence their glucose levels.
• 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.

Behavioral:
• Coaching
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.

Locations

Country	Name	City	State
United States	Rogelio Machuca, MD Family Medicine, PLLC	Las Vegas	Nevada

Sponsors (1)

Lead Sponsor	Collaborator
Savvysherpa, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Program Enrollment Rate (%)	(Number of patients who signed a consent form)/(Number of patients invited to enroll)	up to three months
Primary	Program Completion Rate (%)	(Number of patients who complete 49 days of CGM use) / (Number of patients who signed the consent form)	up to six months
Secondary	Change in A1c Measurement (%)	(Final A1c measure)-(Initial A1c measure)	Day 0 and Day 180
Secondary	Weekly Average of Estimated Glucose Values (EGV) (Average)	(Sum of EGV for one week)/(Total number of EGV)	up to six months
Secondary	Change in Medication Dosage (mg/Day; U/Day)	(dosage of Rx on Day 180)-(dosage of Rx on Day 0)	up to six months
Secondary	Average Age of Participants Who Start Trial (Yrs)	(Sum of ages of all enrollees)/(Total number of enrollees)	up to three months
Secondary	Average Age of Participants Who Complete Trial (Yrs)	(Sum of age of patients who complete)/(Total number who complete)	up to six months
Secondary	Race of Participants Who Start the Trial (n)	Sum of American Indian or Alaska Native, Sum of Asian, Sum of Black or African American, Sum of Native Hawaiian or Other Pacific Islander, Sum of White	up to three months
Secondary	Ethnicity of Participants Who Start the Trial (n)	Sum of Hispanic or Latino and Sum of Not Hispanic or Latino	up to three months
Secondary	Texting With Coaches (Daily Average of Text Messages)	(Sum of all text messages)/(Total number of days)	up to six months
Secondary	Coaching Participation Rate	(Sum of weekly coaching calls completed)/(Total number of weeks)	up to six months