Continuous Glucose Monitors to Regulate Glucose Levels in Type 2 Diabetics - (Protocol 3)

Not Applicable

Completed

• Conditions: Type2 Diabetes
• Interventions: Device: Continuous Glucose Monitor (CGM); Device: Activity Tracker; Behavioral: Coaching

• Registration Number: NCT03290768
• Lead Sponsor: Savvysherpa, Inc.

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-09-13
• Study First Submitted: 2017-09-19
• Study First Submitted QC: 2017-09-20
• Study First Posted: 2017-09-25
• Status Verified: 2018-06
• Primary Completion: 2018-06-01
• Study Completion: 2018-06-01
• Results First Submitted: 2019-05-23
• Results First Submitted QC: 2019-06-25
• Results First Posted: 2019-07-16
• Last Update Submitted: 2021-04-27
• Last Update Posted: 2021-05-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 358

Inclusion Criteria

• Be diagnosed with type 2 diabetes
• Be able to read and understand English
• Have access to a telephone
• Have a Medicare Advantage health plan through Senior Dimensions

Exclusion Criteria

• Pregnant

• Blind

• Deaf

• Receiving chemotherapy or radiation to treat cancer (now or in past 6 months)

• Misusing 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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Diabetes Management Educational Program	Continuous Glucose Monitor (CGM)	Subjects receive a CGM and activity tracker as part of a educational program to help manage their glucose levels.
Diabetes Management Educational Program	Coaching	Subjects receive a CGM and activity tracker as part of a educational program to help manage their glucose levels.
Diabetes Management Educational Program	Activity Tracker	Subjects receive a CGM and activity tracker as part of a educational program to help manage their glucose levels.

Primary Outcome Measures

Name	Time	Method
Program Enrollment Rate (%)	up to 9 months	(Number of patients who were shipped devices) / (Number of patients invited to enroll) \* 100
Program Completion Rate (%)	up to 9 months	(Number of patients who complete 10 weeks of CGM) / (Number of patients who received devices) \* 100

Secondary Outcome Measures

Name	Time	Method
Coaching Participation Rate	up to 9 months	(Sum of weekly coaching calls completed) / (Total number of participants\*weeks)
Change in Medication Dosage (mg/Day; U/Day)	up to 9 months	(dosage of Rx on Day 180) - (dosage of Rx on Day 0)
Average Age of Participants Who Complete Trial (Yrs)	up to 9 months	(Sum of age of patients who complete) / (Total number who complete)
Weekly Average of Estimated Glucose Values (EGV)	up to 10 weeks	(Sum of EGV for a given week) / (Total number of EGV for a given week)
Average Age of Participants Who Start Trial (Yrs)	up to 9 months	(Sum of ages of all enrollees) / (Total number of enrollees)
Texting With Coaches	up to 9 months	(Sum of all text messages) / (Total number of participants\*days)

Trial Locations

Locations (1)

Southwest Medical Associates; 🇺🇸 Las Vegas, Nevada, United States