Continuous Monitoring and Control of Hypoglycemia (COACH)

September 17, 2021 updated by: DexCom, Inc.

Post Approval Study for Non-Adjunctive Use of Dexcom G5 and G6 CGM System for Diabetes Management

Evaluate safety of non-adjunctive CGM use in CGM naive participants.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The study comprises recruitment and consenting of pediatric and adult participants. At entry, the following information will be collected: demographics, labs, clinical and diabetes history information (history of mild/severe hypoglycemia or DKA events in the past 6 months and SMBG testing frequency). There are 3 clinic visits: Study Entry, Month 6 and Month 12 . Monthly phone contacts will be made to assess for any mild/severe hypoglycemic or DKA events and any details surrounding an event. Clinic visits at Months 6 and 12 will capture frequency of SMBG testing, A1C level and PRO information. CGM data will be obtained during the study to assess for CGM adherence.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1388

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • United States
    • California
      • La Jolla, California, United States, 92037
        • Completed
        • Scripps Whittier Diabetes Institute
      • La Mesa, California, United States, 91942
        • Completed
        • Diabetes and Endocrine Associates
      • Sacramento, California, United States, 95821
        • Recruiting
        • Centre of Excellence in Diabetes and Endocrinology
        • Principal Investigator:
          • Gnanagurudasan Prakasam, M.D.
        • Contact:
      • San Mateo, California, United States, 94401
        • Completed
        • Mills-Peninsula Medical Center
      • Santa Barbara, California, United States, 93105
        • Completed
        • Sansum Diabetes Research Institute
    • Florida
      • Gainesville, Florida, United States, 32608
        • Active, not recruiting
        • University of Florida Pediatric Endocrinology
      • Pembroke Pines, Florida, United States, 33024
        • Recruiting
        • Intervent Clinical Research Center
        • Contact:
        • Principal Investigator:
          • Diego Montes, MD
      • Tampa, Florida, United States, 33612
        • Recruiting
        • University of South Florida Clinical Research Center
        • Contact:
        • Contact:
        • Principal Investigator:
          • Henry Rodriguez, M.D.
    • Georgia
      • Atlanta, Georgia, United States, 30318
        • Completed
        • Atlanta Diabetes
    • Idaho
      • Idaho Falls, Idaho, United States, 83404
        • Completed
        • Rocky Mountain Diabetes Center
    • Illinois
      • Skokie, Illinois, United States, 60077
        • Completed
        • Northshore University Health System
    • Iowa
      • Des Moines, Iowa, United States, 50314
        • Completed
        • Iowa Diabetes & Endocrinology Research Center
    • Kansas
      • Topeka, Kansas, United States, 66606
        • Recruiting
        • Cotton O'Neil Clinical Research
        • Contact:
        • Principal Investigator:
          • Susan Brian, M.D.
    • Minnesota
      • Minneapolis, Minnesota, United States, 55416
        • Completed
        • International Diabetes Research Center
    • Missouri
      • Kansas City, Missouri, United States, 64108
        • Recruiting
        • Children's Mercy Hospital
        • Contact:
        • Principal Investigator:
          • Mark Clements, M.D.,PhD.
    • Nebraska
      • Omaha, Nebraska, United States, 68114
        • Completed
        • Methodist Physicians Clinic - Diabetes and Endocrine Specialists
    • North Carolina
      • Asheville, North Carolina, United States, 28803
        • Completed
        • Mountain Diabetes and Endocrine Center
      • Morehead City, North Carolina, United States, 28557
        • Completed
        • Carteret Medical Group
      • Morehead City, North Carolina, United States, 28557
        • Completed
        • Diabetes & Endocrinology Consultants, PC
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73104
        • Recruiting
        • University of Oklahoma Health Sciences Center Department of Pediatric Diabetes and Endocrinology
        • Contact:
        • Principal Investigator:
          • David Sparling, M.D.
    • Tennessee
      • Nashville, Tennessee, United States, 37212
        • Completed
        • Vanderbilt Eskind Diabetes Clinic
    • Texas
      • Amarillo, Texas, United States, 79106
        • Recruiting
        • Amarillo Medical Specialists, LLP
        • Contact:
        • Principal Investigator:
          • William Biggs, M.D.
      • Austin, Texas, United States, 78731
        • Completed
        • Texas Diabetes and Endocrine
      • Dallas, Texas, United States, 75231
        • Completed
        • Research Institute Of Dallas
    • Utah
      • Ogden, Utah, United States, 84405
        • Recruiting
        • Advanced Research Associates
        • Contact:
        • Principal Investigator:
          • Jack Wahlen, M.D., PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

1 year and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Adults and pediatrics (2 or older), naïve to CGM, with Type 1 or insulin-requiring Type 2 diabetes

Description

Inclusion Criteria:

  • Naïve to real-time CGM
  • Type 1 or insulin-requiring Type 2 diabetes
  • ≥ 2 years old

Exclusion Criteria:

  • Use of RT-CGM, within the past 12 months
  • Pregnancy
  • Concomitant disease or condition that may compromise patient safety including and not limited to severe mental illness, a diagnosed or suspected eating disorder or any uncontrolled long term medical condition that would interfere with study related tasks or visits, or ongoing treatment for a significant malignancy.
  • Known (or suspected) significant allergy to medical grade adhesives
  • Dialysis

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
CGM/BGM Group
single-group, whereby participant is their own control. Use of a Blood Glucose Meter (BGM) for 6 months is compared to use of the G5 and G6 CGM System for 6 months, with collection of major diabetes related events (mild/severe hypoglycemia and DKA).
Device: Continuous Glucose Monitoring (CGM)
Use of CGM to compare incidence of diabetes events compared to use of a blood glucose meter (BGM)

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in hypoglycemic events
Time Frame: 6 months
Change in average number of hypoglycemic events per patient between CGM use compared to BGM use
6 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in A1C
Time Frame: 6 months
Percent change in A1C lab between CGM use period compared to BGM use period.
6 months
Change in incidence of hypoglycemic events
Time Frame: 6 months
Percent change of participants with at least one event between CGM use period compared to BGM use period.
6 months
Change in GMSS PRO scores
Time Frame: 6 months
Percent change in mean scores for the Glucose monitoring satisfaction survey (GMSS) [Emotional and Trust subscales] between CGM use period compared to BGM use period.
6 months
Change in Diabetes Distress Scale (DDS) PRO scores
Time Frame: 6 months
Percent change in mean scores for the DDS between CGM use period compared to BGM use period.
6 months
Change in Hypoglycemia Fear PRO scores
Time Frame: 6 months
Percent change in mean scores for the Hypoglycemia Fear Survey between CGM use period compared to BGM use period.
6 months
Change in Hypoglycemia Confidence PRO scores
Time Frame: 6 months
Percent change in mean scores for the Hypoglycemia Confidence Scale between CGM use period compared to BGM use period.
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
DexCom, Inc.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: David Price, MD, Dexcom-Medical Affairs

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 20, 2017

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 30, 2023

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 30, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 31, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 8, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 14, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 21, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 17, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2021

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • PTL-901895

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

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.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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