Feasibility and Clinical Utility of the Dexcom G6 Continuous Glucose Monitoring Device for Type 2 Diabetes

NCT05523362 | Completed Results FDA Device

• 1 other identifier: STUDY20221148
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

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.

Conditions

Type 2 Diabetes

Outcome Measures

Primary Outcomes (3)

• Change in Average Glucose Levels as Measured by Continuous Glucose Monitor

  Average glucose on CGM

  0, 30, 60, 90 days

• Change in Time in Range as Measured by Continuous Glucose Monitor

  Time in range is the time spent in the acceptable glucose range between 80-180 mg/dl. This time in range is noted as a proportion of time that the blood glucose is in this range out of the total time. So if the person's glucose is in this range 70% of the time (and out of it 30%), then Time in Range is 70%.

  0, 30, 60, 90 days

• Change in Glucose Variability as Measured by Continuous Glucose Monitor

  Glucose variability on CGM is defined as standard deviation of the all recorded glucose values.

  0, 30, 60, 90 days

Secondary Outcomes (12)

• Change in Hemoglobin A1c From Blood Test

  0 and 90 days

• Change in Total Cholesterol From Blood Test

  0 and 90 days

• Change in Low Density Lipoprotein Cholesterol From Blood Test

  0 and 90 days

• Change in High Density Lipoprotein Cholesterol From Blood Test

  0 and 90 days

• Change in Triglycerides From Blood Test

  0 and 90 days

Study Arms (1)

Blinded followed by Unblinded

EXPERIMENTAL

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.

Device: Dexcom continuous glucose monitor

Interventions

Dexcom continuous glucose monitor DEVICE

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

Blinded followed by Unblinded

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ian J. Neeland, MD: lead
• DexCom, Inc.: collaborator

Study Sites (1)

University Hospitals Cleveland Medical Center

Cleveland, Ohio, 44106, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Results Point of Contact

• Title: Dr. Ian Neeland
• Organization: University Hospitals Cleveland Medical Center

Ian.Neeland@UHhospitals.org

(216)844-5965

Study Officials

• Ian Neeland, MD

  University Hospitals Cleveland Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: The device is used in blinded mode where both patient and provider are blinded to the data only during Phase 1.
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Director, UH Center for Cardiovascular Prevention

Study Record Dates

• First Submitted: August 29, 2022
• First Posted: August 31, 2022
• Study Start: January 15, 2022
• Primary Completion: November 30, 2023
• Study Completion: November 30, 2023
• Last Updated: August 6, 2024
• Results First Posted: August 6, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)