Clinical trial NCT05523362: Feasibility and Clinical Utility of the Dexcom G6 Continuous Glucose Monitoring Device for Type 2 Diabetes
Official title: Feasibility and Clinical Utility of the Dexcom G6 Continuous Glucose Monitoring Device for the Care of Patients With Type 2 Diabetes Not Using Insulin Therapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 2 Diabetes
Lead sponsor: University Hospitals Cleveland Medical Center
Sponsor class: OTHER
Collaborators: name: DexCom, Inc.
First posted: 2022-08-31
Enrollment: 56
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: The objective of this study is to evaluate the feasibility and clinical utility of a continuous glucose monitoring device (CGM, Dexcom G6) for the care of patients with type 2 diabetes who are on non-insulin therapies.

Detailed description: The investigational device used in this study is the Dexcom G6 Pro/Personal Continuous Blood Glucose Monitoring system.

This investigation is a 2-phase sequential study with patients serving as their own controls. The demographics, medical history, anthropometric and laboratory data are collected at baseline for each patient. During Phase 1 (10 days), the patient wears the Dexcom G6 Pro CGM in blinded mode and is unaware and unable to access the data. The patient performs standard care, self-monitoring with twice daily glucose checks using standard finger-sticks and a glucometer device. During this phase, the medical providers are also blinded to the CGM data and continue standard care without any specific intervention.

During Phase 2 (3 months), the patient wears the Dexcom G6 Personal CGM in un-blinded mode and the medical providers have access to the data via Clarity and/or direct download via the transmitter. CGM data are collected continuously in each phase and at the end of each phase. Anthropometric and laboratory data (including HB A1c) are collected. Medical providers are also un-blinded and adjust medical recommendations and interventions, in part based on CGM data, as appropriate.

All patients will receive usual care which will include individual and virtual lifestyle education, virtual support group, M.D. visits, medication interventions, referrals to support programs outside the scope of CINEMA program and nursing support

Eligibility criteria: Inclusion Criteria:

* Type 2 diabetes of any duration
* Hb A1c ≥ 7% (no upper limit)
* BMI ≥ 30 kg/m2
* Ability to wear CGM (e.g. no dermatological issue precluding device insertion)
* Access to a smartphone device

Exclusion Criteria:

* Any insulin use in the past 3 months
* Planned use of insulin in the next 6 months
* Presence of a blood disorder (such as sickle cell anemia) making glycosylated hemoglobin measurement inaccurate
* Current use of a weight loss medication
* Unable or uncomfortable with wearing a CGM device

Primary outcomes:
measure: Change in Average Glucose Levels as Measured by Continuous Glucose Monitor
timeFrame: 0, 30, 60, 90 days
measure: Change in Time in Range as Measured by Continuous Glucose Monitor
timeFrame: 0, 30, 60, 90 days
measure: Change in Glucose Variability as Measured by Continuous Glucose Monitor
timeFrame: 0, 30, 60, 90 days
Secondary outcomes:
measure: Change in Hemoglobin A1c From Blood Test
timeFrame: 0 and 90 days
measure: Change in Total Cholesterol From Blood Test
timeFrame: 0 and 90 days
measure: Change in Low Density Lipoprotein Cholesterol From Blood Test
timeFrame: 0 and 90 days
measure: Change in High Density Lipoprotein Cholesterol From Blood Test
timeFrame: 0 and 90 days
measure: Change in Triglycerides From Blood Test
timeFrame: 0 and 90 days
measure: Change in Body Mass Index From Height and Weight
timeFrame: 0 and 90 days
measure: Change in Systolic Blood Pressure From Automated Cuff
timeFrame: 0 and 90 days
measure: Change in Diastolic Blood Pressure From Automated Cuff
timeFrame: 0 and 90 days
measure: Picture Your Plate Dietary Assessment Questionnaire
timeFrame: 0, 90 days
measure: Type 2 Diabetes Distress Screening Scale (T2-DDAS)
timeFrame: 0, 90 days
measure: International Physical Activity Questionnaire (IPAQ)
timeFrame: 0, 90 days
measure: Glucose Monitoring Satisfaction Survey
timeFrame: 90 days
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: University Hospitals Cleveland Medical Center
state: Ohio
Study officials:
affiliation: University Hospitals Cleveland Medical Center
name: Ian Neeland, MD
role: PRINCIPAL_INVESTIGATOR
References: