Dexcom continuous glucose monitor for Type 2 Diabetes

N/A

Recruiting

Led By Ian Neeland, MD

Research Sponsored by University Hospitals Cleveland Medical Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

BMI ≥ 30 kg/m2

Type 2 diabetes of any duration

Must not have

Be younger than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up0, 30, 60, 90 days

Awards & highlights

No Placebo-Only Group

Study Summary

This trial will test whether a continuous glucose monitoring device is helpful for people with type 2 diabetes who are not taking insulin.

Eligible Conditions

Type 2 Diabetes

Eligibility Criteria

Inclusion Criteria

You will be eligible if you check “Yes” for the criteria below

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You have a body mass index (BMI) of 30 or higher.

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You have been diagnosed with type 2 diabetes, regardless of how long you have had it.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 0, 30, 60, 90 days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~0, 30, 60, 90 days

This trial's timeline: 3 weeks for screening, Varies for treatment, and 0, 30, 60, 90 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Glucose

Change in glucose variability as measured by continuous glucose monitor

Change in time in range as measured by continuous glucose monitor

Secondary outcome measures

Change in Blood pressure from automated cuff

Change in Body mass index from height and weight

Body Weight Changes

+8 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: UnblindedExperimental Treatment1 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.

Group II: BlindedActive Control1 Intervention

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Dexcom continuous glucose monitor

2018

N/A

~110

0 / 2Eligibility criteria met

Find a site

Who is running the clinical trial?

DexCom, Inc.Industry Sponsor

131 Previous Clinical Trials

29,554 Total Patients Enrolled

University Hospitals Cleveland Medical CenterLead Sponsor

311 Previous Clinical Trials

339,768 Total Patients Enrolled

Ian J. Neeland, MDLead Sponsor

1 Previous Clinical Trials

220 Total Patients Enrolled

Ian Neeland, MDPrincipal Investigator

University Hospitals Cleveland Medical Center

3 Previous Clinical Trials

410 Total Patients Enrolled

Media Library

Type 2 Diabetes Research Study Groups: Blinded, Unblinded

Type 2 Diabetes Clinical Trial 2023: Dexcom continuous glucose monitor Highlights & Side Effects. Trial Name: NCT05523362 — N/A

Dexcom continuous glucose monitor 2023 Treatment Timeline for Medical Study. Trial Name: NCT05523362 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is it possible to join this experiment?

"This trial is searching for 50 individuals who have been diagnosed with type 2 diabetes mellitus and lie between the ages of 18-99."

Answered by AI

What is the intended result of this research?

"According to DexCom, Inc., the primary metric of this study will be Change in Glucose Variability as monitored by a Continuous Glucose Monitor. Meanwhile, International Physical Activity Questionnaires (IPAQ), Hemoglobin A1c levels from blood samples and patient responses to the Glucose Monitoring Satisfaction Survey are also being assessed over 0-90 day intervals."

Answered by AI

Are there remaining opportunities to join this research trial?

"Per the clinicaltrials.gov database, this medical trial is not actively looking for participants. The first posting was on December 1st 2022 and it has since been updated to October 19th of the same year. Even though registration is currently closed, there are still 1440 other trials recruiting patients at present."

Answered by AI