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

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ClinicalTrials.gov Identifier: NCT03620357
Recruitment Status : Recruiting
First Posted : August 8, 2018
Last Update Posted : October 9, 2018
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.


Study Type : Interventional  (Clinical Trial)
Estimated 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 : June 15, 2019
Estimated Study Completion Date : December 31, 2019

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).



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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


Contacts
Contact: Paul Genge 858-203-6096 paul.genge@dexcom.com

Locations
United States, California
Diabetes/Lipid Managment and Research Center Recruiting
Huntington Beach, California, United States, 92648
Contact: Ni Yao       niyao@researchca.com   
Principal Investigator: Paul D. Rosenblit, M.D., Ph.D.         
United States, Georgia
Atlanta Diabetes Associates Recruiting
Atlanta, Georgia, United States, 30318
Contact: Tracy Lawrence       Tlawrence@atlantadiabetes.com   
Principal Investigator: Bruce W. Bode, M.D.         
United States, Maryland
MODEL Clinical Research (Towson) Recruiting
Baltimore, Maryland, United States, 21204
Contact: Karen Klein    443-524-1789    KarenKlein99@hotmail.com   
Principal Investigator: Philip Levin, M.D.         
United States, Nevada
Las Vegas Endocrinology Recruiting
Henderson, Nevada, United States, 89052
Contact: Alejandra Martinez       zillah725@gmail.com   
Contact: Loida Nguyen       loida.lvendo@gmail.com   
Principal Investigator: Quang Nguyen, D.O.         
United States, Texas
Diabetes and Glandular Disease Clinic Recruiting
San Antonio, Texas, United States, 78229
Contact: Terri Ryan       Terri.Ryan@dgdclinic.com   
Principal Investigator: Mark Kipnes, M.D.         
Sponsors and Collaborators
DexCom, Inc.
Investigators
Study Director: David Price, MD DexCom, Inc.

Responsible Party: DexCom, Inc.
ClinicalTrials.gov Identifier: NCT03620357     History of Changes
Other Study ID Numbers: PTL903076
First Posted: August 8, 2018    Key Record Dates
Last Update Posted: October 9, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases