Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 1 for:    Dexcom g6 COMMITED
Previous Study | Return to List | Next Study

Continuous Glucose Monitoring & Management In Type 2 Diabetes (T2D) (COMMITED)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03620357
Recruitment Status : Active, not recruiting
First Posted : August 8, 2018
Last Update Posted : January 3, 2020
Sponsor:
Information provided by (Responsible Party):
DexCom, Inc.

Brief Summary:
A Study to assess if patients with Type 2 diabetes (T2D) who have suboptimal glycemic control using multiple oral agents are able to make lifestyle changes resulting in improved glycemic control by use of real-time continuous glucose monitoring (RT-CGM) and targeted learning modules versus self monitored blood glucose (SMBG) testing.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus, Type 2 Device: CGM Device: SMBG Not Applicable

Detailed Description:

The study is referred to as "Continuous Glucose Monitoring and Management in Type 2 Diabetes" also known as The COMMITED Study" and will assess if patients with Type 2 diabetes (T2D) who have suboptimal glycemic control using 2 or more multiple oral agents are able to make lifestyle changes resulting in improved glycemic control by use of real-time continuous glucose monitoring and targeted learning modules.

At time of enrollment, participants will undergo a run-in period of blinded CGM for a duration of 10 days to collect baseline data. Baseline Patient Report Outcome (PRO) surveys will be administered at the start of run-in.

The study design includes a run-in phase, a study phase and a follow up visit. During the study phase, participants will be randomized into two groups - CGM Group or SMBG Group. For the RT-CGM Group, the study comprises of 4 scheduled clinic visits at baseline (after Run-In), week 4, week 8, and week 12 to collect data on episodic RT-CGM use. During these visits, RT-CGM insertions will take place at baseline, week 4 and week 8 clinic visits, with each wear period lasting a duration of 10 days. For the SMBG Group, the study comprises of 3 scheduled clinic visits at baseline (after Run-In), week 8 (to collect data on episodic blinded CGM use) and week 12. CGM insertions will take place at week 8 with a wear period of 10 days. Both groups will have HbA1c collected at week 0 and week 12. The same PRO surveys administered at start of run-in will be administered again at week 12. There will not be therapeutic changes during the study phase unless needed for safety.

There will be phone/remote visits by a study site clinician at weeks 2, 6 and 10 in both groups to review the SMBG or CGM data. During these remote visits, there will be discussions about what the subjects have learned from their glucose monitoring and what the study clinician has observed.

All subjects will be scheduled for a follow up visit at Month 9 to obtain local lab or POC HbA1c. Diabetes medications (classifications only) will also be collected.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 72 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Prospective, randomized, multicenter, two-arm confirmatory study.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Continuous Glucose Monitoring & Management In Type 2 Diabetes
Actual Study Start Date : September 5, 2018
Estimated Primary Completion Date : May 1, 2020
Estimated Study Completion Date : December 31, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Continuous Glucose Monitor (CGM) Group Device: CGM
CGM Group: Dexcom G6 CGM

Active Comparator: SMBG Group Device: SMBG
SMBG Group: Blood Glucose Meter




Primary Outcome Measures :
  1. HbA1c [ Time Frame: From baseline to Month 3 (Week 12) and to Month 9 (Week 36). ]
    The primary endpoint is defined as change in HbA1c (determined by local lab or POC results).



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   30 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Major Inclusion Criteria:

  • Age at least 30 years
  • Diagnosis of T2D treated with 2 or more oral anti-diabetic medications
  • HbA1c ≥ 7.8 and ≤10.5% by local lab or POC

Major Exclusion Criteria:

  • Using insulin
  • Pregnancy
  • Estimated glomerular filtration rate (eGFR) <30 mL/min/1.73m2

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03620357


Locations
Layout table for location information
United States, California
Diabetes/Lipid Managment and Research Center
Huntington Beach, California, United States, 92648
Bill L Jou, M.D. Inc.
Temecula, California, United States, 92592
United States, Georgia
Atlanta Diabetes Associates
Atlanta, Georgia, United States, 30318
United States, Maryland
MODEL Clinical Research (Towson)
Baltimore, Maryland, United States, 21204
United States, Nebraska
Diabetes & Endocrine Associates, PC
Omaha, Nebraska, United States, 68114
United States, Nevada
Las Vegas Endocrinology
Henderson, Nevada, United States, 89052
The Docs
Las Vegas, Nevada, United States, 89113
Palm Research Center
Las Vegas, Nevada, United States, 89148
United States, Texas
Diabetes and Glandular Disease Clinic
San Antonio, Texas, United States, 78229
Sponsors and Collaborators
DexCom, Inc.
Investigators
Layout table for investigator information
Study Director: David Price, MD DexCom, Inc.
Layout table for additonal information
Responsible Party: DexCom, Inc.
ClinicalTrials.gov Identifier: NCT03620357    
Other Study ID Numbers: PTL903076
First Posted: August 8, 2018    Key Record Dates
Last Update Posted: January 3, 2020
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases