Diabetes Mellitus, Type 2COMMITEDNCT03620357
Continuous Glucose Monitoring & Management In Type 2 Diabetes (T2D)
A study testing CGM and SMBG in people with Diabetes Mellitus, Type 2, run by DexCom, Inc. at 10 sites in 2 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 30 years and older
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- CGM and SMBG
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 10 sitesin 2 countries
- Study dates
- 5 Sep 2018to 4 Nov 2020
- Phase
- Interventional
- 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 30 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Trial locations and contacts
10 sites in 2 countries.
10 sites in 2 countries
United States9 sites
Atlanta Diabetes Associates
Atlanta, Georgia, 30318
MODEL Clinical Research (Towson)
Baltimore, Maryland, 21204
Las Vegas Endocrinology
Henderson, Nevada, 89052
Diabetes/Lipid Management and Research Center
Huntington Beach, California, 92648
The Docs
Las Vegas, Nevada, 89113
Palm Research Center
Las Vegas, Nevada, 89148
Diabetes & Endocrine Associates, PC
Omaha, Nebraska, 68114
Diabetes and Glandular Disease Clinic
San Antonio, Texas, 78229
Temecula Valley Endocrinology
Temecula, California, 92592
About this study
Official title: Continuous Glucose Monitoring & Management In Type 2 Diabetes
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.
Read the 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.
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- CGM, SMBG
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CGMDevice
CGM Group: Dexcom G6 CGM
SMBGDevice
SMBG Group: Blood Glucose Meter
| Study group | Role | What they receive |
|---|---|---|
| Continuous Glucose Monitor (CGM) Group | Experimental | Not described Receives: Device: CGM |
| SMBG Group | Active comparator | Not described Receives: Device: SMBG |
What is being measured
The primary outcome is the main question the study is designed to answer.
HbA1c
The primary endpoint is defined as change in HbA1c (determined by local lab or POC results).
Measured: From baseline to Month 3 (Week 12)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2018
- Study start5 Sep 2018
- Primary completion27 May 2020
- Study completion4 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 2Studies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Prospective, randomized, multicenter, two-arm pilot study.
- Masking
- None (open label)
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- DexCom, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- David Price, MD, Study director, DexCom, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03620357
- Sponsor's protocol ID
- PTL903076
- Acronym
- COMMITED
- Status last verified
- Mar 2021
- First submitted
- 31 Jul 2018
- Last updated
- 22 Mar 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 22 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Continuous Glucose Monitoring & Management In Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT03620357
- Acronym / sponsor ID
- COMMITED / PTL903076
- Conditions
- Diabetes Mellitus, Type 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- DexCom, Inc.Industry (pharma, biotech, devices)
- Study start
- 5 Sep 2018 (actual)
- Primary completion
- 27 May 2020 (actual)
- Study completion
- 4 Nov 2020 (actual)
- First posted
- 8 Aug 2018 (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.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Prospective, randomized, multicenter, two-arm pilot study.
| Arm | Type | Receives |
|---|---|---|
| Continuous Glucose Monitor (CGM) Group | Experimental | Device: CGM |
| SMBG Group | Active comparator | Device: SMBG |
Who may qualify
- Ages
- 30 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| CGMCGM Group: Dexcom G6 CGM | Device | Continuous Glucose Monitor (CGM) Group |
| SMBGSMBG Group: Blood Glucose Meter | Device | SMBG Group |
Primary outcome
HbA1c
Time frame: From baseline to Month 3 (Week 12)
The primary endpoint is defined as change in HbA1c (determined by local lab or POC results).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 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, Inc.
10 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CGM and SMBG in people with Diabetes Mellitus, Type 2, run by DexCom, Inc. at 10 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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: finished, as of the sponsor's last update on 22 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in United States, Canada. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HbA1c (time frame: From baseline to Month 3 (Week 12)). 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 22 Mar 2021.