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

Savvysherpa, Inc.358 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

358

Conditions

Type2 Diabetes

Interventions

Continuous Glucose Monitor (CGM)DEVICE

Subjects will use a CGM to develop an understanding of how their behaviors influence their glucose levels.

Activity TrackerDEVICE

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.

CoachingBEHAVIORAL

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.

Eligibility

Sex: ALLMin age: 65 Years

Medical Language ↔ Plain English

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)

Locations (1)

Southwest Medical Associates

Las Vegas, Nevada, United States

Outcomes

Primary Outcomes

Program Enrollment Rate (%)

(Number of patients who were shipped devices) / (Number of patients invited to enroll) \* 100

Time frame: up to 9 months

Program Completion Rate (%)

(Number of patients who complete 10 weeks of CGM) / (Number of patients who received devices) \* 100

Time frame: up to 9 months

Secondary Outcomes

Weekly Average of Estimated Glucose Values (EGV)

(Sum of EGV for a given week) / (Total number of EGV for a given week)

Time frame: up to 10 weeks

Change in Medication Dosage (mg/Day; U/Day)

(dosage of Rx on Day 180) - (dosage of Rx on Day 0)

Time frame: up to 9 months

Average Age of Participants Who Start Trial (Yrs)

(Sum of ages of all enrollees) / (Total number of enrollees)

Time frame: up to 9 months

Average Age of Participants Who Complete Trial (Yrs)

(Sum of age of patients who complete) / (Total number who complete)

Time frame: up to 9 months

Texting With Coaches

(Sum of all text messages) / (Total number of participants\*days)

Time frame: up to 9 months

Coaching Participation Rate

(Sum of weekly coaching calls completed) / (Total number of participants\*weeks)

Time frame: up to 9 months

Data from ClinicalTrials.gov

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