DiabetesCOACHNCT03340831
Continuous Monitoring and Control of Hypoglycemia
An observational study of Diabetes, run by DexCom, Inc. at 25 sites in United States.
Trial summary
Evaluate safety of non-adjunctive CGM use in CGM naive participants. Read more about this study
- Who is it for?
- Ages 2 years and older
- Conditions the study is for
- Diabetes
- What is being tested?
- Continuous Glucose Monitoring (CGM)
- Type of treatment
- Medical device
- How many people
- 1,388 participants
- Where
- 25 sitesUnited States
- Study dates
- 20 Oct 2017to 30 Dec 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Adults and pediatrics (2 or older), naïve to CGM, with Type 1 or insulin-requiring Type 2 diabetes
Who may be able to join
- Naïve to real-time CGM
- Type 1 or insulin-requiring Type 2 diabetes
- ≥ 2 years old
Who cannot join
- 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
Trial locations and contacts
25 sites in 1 country.
25 sites in 1 country
United States25 sites, 8 recruiting
- Recruiting
Amarillo Medical Specialists, LLP
Amarillo, Texas, 79106
Becky Cota, RN, CDE, 806-358-8331, becky.cota@amarillomed.com
William Biggs, M.D.
- Completed
Mountain Diabetes and Endocrine Center
Asheville, North Carolina, 28803
- Completed
Atlanta Diabetes
Atlanta, Georgia, 30318
- Completed
Texas Diabetes and Endocrine
Austin, Texas, 78731
- Completed
Research Institute of Dallas
Dallas, Texas, 75231
- Completed
Iowa Diabetes & Endocrinology Research Center
Des Moines, Iowa, 50314
- Active, not recruiting
University of Florida Pediatric Endocrinology
Gainesville, Florida, 32608
- Completed
Rocky Mountain Diabetes Center
Idaho Falls, Idaho, 83404
- Recruiting
Children's Mercy Hospital
Kansas City, Missouri, 64108
Jennifer L James, jljames@cmh.edu;
Mark Clements, M.D.,PhD.
- Completed
Scripps Whittier Diabetes Institute
La Jolla, California, 92037
- Completed
Diabetes and Endocrine Associates
La Mesa, California, 91942
- Completed
International Diabetes Research Center
Minneapolis, Minnesota, 55416
- Completed
Carteret Medical Group
Morehead City, North Carolina, 28557
- Completed
Diabetes & Endocrinology Consultants, PC
Morehead City, North Carolina, 28557
- Completed
Vanderbilt Eskind Diabetes Clinic
Nashville, Tennessee, 37212
- Recruiting
Advanced Research Associates
Ogden, Utah, 84405
Hilary Wahlen, 801-409-2040, hilary@advresearch.org
Jack Wahlen, M.D., PhD
- Recruiting
University of Oklahoma Health Sciences Center Department of Pediatric Diabetes and Endocrinology
Oklahoma City, Oklahoma, 73104
LInda Weber, Linda-weber@ouhsc.edu
David Sparling, M.D.
- Completed
Methodist Physicians Clinic - Diabetes and Endocrine Specialists
Omaha, Nebraska, 68114
- Recruiting
Intervent Clinical Research Center
Pembroke Pines, Florida, 33024
Marisela Rodriguez, 954-507-6627, mrodriguez@interventcrc.com
Diego Montes, MD
- Recruiting
Centre of Excellence in Diabetes and Endocrinology
Sacramento, California, 95821
Mila Melnik, cedelead@yahoo.com
Gnanagurudasan Prakasam, M.D.
- Completed
Mills-Peninsula Medical Center
San Mateo, California, 94401
- Completed
Sansum Diabetes Research Institute
Santa Barbara, California, 93105
- Completed
Northshore University Health System
Skokie, Illinois, 60077
- Recruiting
University of South Florida Clinical Research Center
Tampa, Florida, 33612
Ponja Hemphill, phemphill@usf.edu
Janet Rodriguez, janetrodriguez@usf.edu
- Recruiting
Cotton O'Neil Clinical Research
Topeka, Kansas, 66606
Jaime Berroth, JBerroth@stormontvail.org
Susan Brian, M.D.
About this study
Official title: 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.
Read the 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.
- Conditions
- Diabetes
- Being tested
- Continuous Glucose Monitoring (CGM)
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Continuous Glucose Monitoring (CGM)Device
Use of CGM to compare incidence of diabetes events compared to use of a blood glucose meter (BGM)
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Device: Continuous Glucose Monitoring (CGM) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in hypoglycemic events
Change in average number of hypoglycemic events per patient between CGM use compared to BGM use
Measured: 6 months
Secondary outcomes (6)
Change in A1C
Percent change in A1C lab between CGM use period compared to BGM use period.
Measured: 6 months
Change in incidence of hypoglycemic events
Percent change of participants with at least one event between CGM use period compared to BGM use period.
Measured: 6 months
Change in GMSS PRO scores
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.
Measured: 6 months
Change in Diabetes Distress Scale (DDS) PRO scores
Percent change in mean scores for the DDS between CGM use period compared to BGM use period.
Measured: 6 months
Change in Hypoglycemia Fear PRO scores
Percent change in mean scores for the Hypoglycemia Fear Survey between CGM use period compared to BGM use period.
Measured: 6 months
Change in Hypoglycemia Confidence PRO scores
Percent change in mean scores for the Hypoglycemia Confidence Scale between CGM use period compared to BGM use period.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2017
- Study start20 Oct 2017
- Primary completion30 Dec 2023 (estimated)
- Study completion30 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,388 participants (estimated)
Sponsor and investigators
- Lead sponsor
- DexCom, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- David Price, MD, Study director, Dexcom-Medical Affairs
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03340831
- Sponsor's protocol ID
- PTL-901895
- Acronym
- COACH
- Status last verified
- Sep 2021
- First submitted
- 31 Oct 2017
- Last updated
- 21 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post Approval Study for Non-Adjunctive Use of Dexcom G5 and G6 CGM System for Diabetes Management
- ClinicalTrials.gov ID
- NCT03340831
- Acronym / sponsor ID
- COACH / PTL-901895
- Conditions
- Diabetes
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,388 participants (estimated)
- Lead sponsor
- DexCom, Inc.Industry (pharma, biotech, devices)
- Study start
- 20 Oct 2017 (actual)
- Primary completion
- 30 Dec 2023 (estimated)
- Study completion
- 30 Dec 2023 (estimated)
- First posted
- 14 Nov 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Evaluate safety of non-adjunctive CGM use in CGM naive participants.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CGM/BGM Group | – | Device: Continuous Glucose Monitoring (CGM)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). |
Who may qualify
- Ages
- 2 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Adults and pediatrics (2 or older), naïve to CGM, with Type 1 or insulin-requiring Type 2 diabetes
Key inclusion criteria (3 listed)
- Naïve to real-time CGM
- Type 1 or insulin-requiring Type 2 diabetes
- ≥ 2 years old
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Continuous Glucose Monitoring (CGM)Use of CGM to compare incidence of diabetes events compared to use of a blood glucose meter (BGM) | Device | CGM/BGM Group |
Primary outcome
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 secondary outcomes
Change in A1C
Time frame: 6 months
Change in incidence of hypoglycemic events
Time frame: 6 months
Change in GMSS PRO scores
Time frame: 6 months
Change in Diabetes Distress Scale (DDS) PRO scores
Time frame: 6 months
Change in Hypoglycemia Fear PRO scores
Time frame: 6 months
Change in Hypoglycemia Confidence PRO scores
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David Price, MD study director
Dexcom-Medical Affairs
25 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetes, run by DexCom, Inc. at 25 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 25 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Stayce Beck, PhD, MPH (8582036454, stayce.beck@dexcom.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in hypoglycemic events (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2021.