Continuous Glucose Monitors to Regulate Glucose Levels in Type 2 Diabetics (CGM_IRB2)

Savvysherpa

Status: Completed

Conditions: Type2 Diabetes

Treatments: Behavioral: Coaching; Device: Continuous Glucose Monitor (CGM); Device: Activity Tracker

Study type: Interventional

Funder types: Industry

Identifiers

NCT03252964

Pro00021722

Details and patient eligibility

About

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.

Enrollment: 52 patients

Sex: All

Ages: 65+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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52 participants in 1 patient group

Diabetes Management Educational Program

Experimental group

Description:

Subjects receive a CGM and activity tracker as part of a educational program to help manage their glucose levels.

Treatment:

Behavioral: Coaching

Device: Activity Tracker

Device: Continuous Glucose Monitor (CGM)