Type 2 DiabetesNCT05523362
Feasibility and Clinical Utility of the Dexcom G6 Continuous Glucose Monitoring Device for Type 2 Diabetes
A study testing Dexcom continuous glucose monitor in people with Type 2 Diabetes, run by Ian J. Neeland, MD at 1 site in United States.
Trial summary
The objective of this study is to evaluate the feasibility and clinical utility of a continuous glucose monitoring device (CGM, Dexcom G6) for the care of patients with type 2 diabetes who are on non-insulin therapies. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- Dexcom continuous glucose monitor
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Jan 2022to 30 Nov 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Type 2 diabetes of any duration
- Hb A1c ≥ 7% (no upper limit)
- BMI ≥ 30 kg/m2
- Ability to wear CGM (e.g. no dermatological issue precluding device insertion)
- Access to a smartphone device
Who cannot join
- Any insulin use in the past 3 months
- Planned use of insulin in the next 6 months
- Presence of a blood disorder (such as sickle cell anemia) making glycosylated hemoglobin measurement inaccurate
- Current use of a weight loss medication
- Unable or uncomfortable with wearing a CGM device
Trial locations and contacts
1 site in 1 country.
United States1 site
University Hospitals Cleveland Medical Center
Cleveland, Ohio, 44106
About this study
Official title: Feasibility and Clinical Utility of the Dexcom G6 Continuous Glucose Monitoring Device for the Care of Patients With Type 2 Diabetes Not Using Insulin Therapy
The objective of this study is to evaluate the feasibility and clinical utility of a continuous glucose monitoring device (CGM, Dexcom G6) for the care of patients with type 2 diabetes who are on non-insulin therapies.
Read the detailed description
The investigational device used in this study is the Dexcom G6 Pro/Personal Continuous Blood Glucose Monitoring system.
This investigation is a 2-phase sequential study with patients serving as their own controls. The demographics, medical history, anthropometric and laboratory data are collected at baseline for each patient. During Phase 1 (10 days), the patient wears the Dexcom G6 Pro CGM in blinded mode and is unaware and unable to access the data. The patient performs standard care, self-monitoring with twice daily glucose checks using standard finger-sticks and a glucometer device. During this phase, the medical providers are also blinded to the CGM data and continue standard care without any specific intervention.
During Phase 2 (3 months), the patient wears the Dexcom G6 Personal CGM in un-blinded mode and the medical providers have access to the data via Clarity and/or direct download via the transmitter. CGM data are collected continuously in each phase and at the end of each phase. Anthropometric and laboratory data (including HB A1c) are collected. Medical providers are also un-blinded and adjust medical recommendations and interventions, in part based on CGM data, as appropriate.
All patients will receive usual care which will include individual and virtual lifestyle education, virtual support group, M.D. visits, medication interventions, referrals to support programs outside the scope of CINEMA program and nursing support
- Conditions
- Type 2 Diabetes
- Being tested
- Dexcom continuous glucose monitor
- 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.
Dexcom continuous glucose monitorDevice
The investigational device used in this study is the Dexcom G6 Pro/Personal Continuous Blood Glucose Monitoring system.
| Study group | Role | What they receive |
|---|---|---|
| Blinded followed by Unblinded | Experimental | During Phase 1 (10 days), the patient wears the Dexcom G6 Pro CGM in blinded mode and is unaware and unable to access the data. The patient performs standard care, self-monitoring with twice daily glucose checks using standard finger-sticks and a glucometer device. During this phase, the medical providers are also blinded to the CGM data and continue standard care without any specific intervention.
During Phase 2 (3 months), the patient wears the Dexcom G6 Personal CGM in un-blinded mode and the medical providers have access to the data via Clarity and/or direct download via the transmitter. CGM data are collected continuously in each phase and at the end of each phase. Receives: Device: Dexcom continuous glucose monitor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Average Glucose Levels as Measured by Continuous Glucose Monitor
Average glucose on CGM
Measured: 0, 30, 60, 90 days
Change in Time in Range as Measured by Continuous Glucose Monitor
Time in range is the time spent in the acceptable glucose range between 80-180 mg/dl. This time in range is noted as a proportion of time that the blood glucose is in this range out of the total time. So if the person's glucose is in this range 70% of the time (and out of it 30%), then Time in Range is 70%.
Measured: 0, 30, 60, 90 days
Change in Glucose Variability as Measured by Continuous Glucose Monitor
Glucose variability on CGM is defined as standard deviation of the all recorded glucose values.
Measured: 0, 30, 60, 90 days
Secondary outcomes (12)
Change in Hemoglobin A1c From Blood Test
Glycosylated hemoglobin
Measured: 0 and 90 days
Change in Total Cholesterol From Blood Test
Total cholesterol
Measured: 0 and 90 days
Change in Low Density Lipoprotein Cholesterol From Blood Test
LDL-C
Measured: 0 and 90 days
Change in High Density Lipoprotein Cholesterol From Blood Test
HDL-C
Measured: 0 and 90 days
Change in Triglycerides From Blood Test
Triglycerides
Measured: 0 and 90 days
Change in Body Mass Index From Height and Weight
BMI
Measured: 0 and 90 days
Change in Systolic Blood Pressure From Automated Cuff
Systolic blood pressure
Measured: 0 and 90 days
Change in Diastolic Blood Pressure From Automated Cuff
Diastolic blood pressure
Measured: 0 and 90 days
Picture Your Plate Dietary Assessment Questionnaire
Picture Your PlateTM is a brief (48-question) dietary assessment questionnaire developed to assess how well an individual's eating habits align with current evidence-based recommendations. Picture Your Plate provides a total score ranging from 0 to 96, with a higher score indicating healthier food choice awareness.
Measured: 0, 90 days
Type 2 Diabetes Distress Screening Scale (T2-DDAS)
The T2-DDAS is a self-report survey that has 29 items. Each item rated on a 1 to 5 scale:
Mean score < 2.0 indicate little or no distress.
Mean score between 2.0 and 2.9 indicate moderate distress.
Mean score > 3.0 indicate high distress
Measured: 0, 90 days
International Physical Activity Questionnaire (IPAQ)
The International Physical Activity Questionnaires (IPAQ) comprises a set of 4 questionnaires.
Long (5 activity domains asked independently) and short (4 generic items) versions for use by either telephone or self-administered methods are available. This measure assesses the types of intensity of physical activity that people do as part of their daily lives. The estimate is measured as total physical activity in MET-min/week. Lower scores mean less total amount and intensity of physical activity and higher scores mean greater total amount and intensity of physical activity in a given week.
Measured: 0, 90 days
Glucose Monitoring Satisfaction Survey
The GMSS is a reliable, valid measure of glucose device satisfaction in its T1D form and in its insulin-using T2D form. It provides a comprehensive profile of sources of device satisfaction for use in clinical care and research.
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2022
- Study start15 Jan 2022
- Primary completion30 Nov 2023
- Study completion30 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Type 2 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ian J. Neeland, MD
- Sponsor type
- University, hospital or other
- Collaborators
- DexCom, Inc.
- Responsible party
- Sponsor-investigator, Ian J. Neeland, MD, University Hospitals Cleveland Medical Center
- Investigators
- Ian Neeland, MD, Principal investigator, University Hospitals Cleveland Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05523362
- Sponsor's protocol ID
- STUDY20221148
- Status last verified
- Jul 2024
- First submitted
- 29 Aug 2022
- Last updated
- 6 Aug 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Reed J, Dong T, Eaton E, Friswold J, Porges J, Al-Kindi SG, Rajagopalan S, Neeland IJ. Continuous glucose monitoring for glycaemic control and cardiovascular risk reduction in patients with type 2 diabetes not on insulin therapy: A clinical trial. Diabetes Obes Metab. 2024 Jul;26(7):2881-2889. doi: 10.1111/dom.15608. Epub 2024 Apr 28.
PubMed 38680050
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility and Clinical Utility of the Dexcom G6 Continuous Glucose Monitoring Device for the Care of Patients With Type 2 Diabetes Not Using Insulin Therapy
- ClinicalTrials.gov ID
- NCT05523362
- Acronym / sponsor ID
- STUDY20221148
- Conditions
- Type 2 Diabetes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Ian J. Neeland, MDUniversity, hospital or other
- Collaborators
- DexCom, Inc.
- Study start
- 15 Jan 2022 (actual)
- Primary completion
- 30 Nov 2023 (actual)
- Study completion
- 30 Nov 2023 (actual)
- First posted
- 31 Aug 2022 (actual)
- Results
- Posted 6 Aug 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this study is to evaluate the feasibility and clinical utility of a continuous glucose monitoring device (CGM, Dexcom G6) for the care of patients with type 2 diabetes who are on non-insulin therapies.
Detailed description
The investigational device used in this study is the Dexcom G6 Pro/Personal Continuous Blood Glucose Monitoring system.
This investigation is a 2-phase sequential study with patients serving as their own controls. The demographics, medical history, anthropometric and laboratory data are collected at baseline for each patient. During Phase 1 (10 days), the patient wears the Dexcom G6 Pro CGM in blinded mode and is unaware and unable to access the data. The patient performs standard care, self-monitoring with twice daily glucose checks using standard finger-sticks and a glucometer device. During this phase, the medical providers are also blinded to the CGM data and continue standard care without any specific intervention.
During Phase 2 (3 months), the patient wears the Dexcom G6 Personal CGM in un-blinded mode and the medical providers have access to the data via Clarity and/or direct download via the transmitter. CGM data are collected continuously in each phase and at the end of each phase. Anthropometric and laboratory data (including HB A1c) are collected. Medical providers are also un-blinded and adjust medical recommendations and interventions, in part based on CGM data, as appropriate.
All patients will receive usual care which will include individual and virtual lifestyle education, virtual support group, M.D. visits, medication interventions, referrals to support programs outside the scope of CINEMA program and nursing support
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Blinded followed by Unblinded | Experimental | Device: Dexcom continuous glucose monitorDuring Phase 1 (10 days), the patient wears the Dexcom G6 Pro CGM in blinded mode and is unaware and unable to access the data. The patient performs standard care, self-monitoring with twice daily glucose checks using standard finger-sticks and a glucometer device. During this phase, the medical providers are also blinded to the CGM data and continue standard care without any specific intervention. During Phase 2 (3 months), the patient wears the Dexcom G6 Personal CGM in un-blinded mode and the medical providers have access to the data via Clarity and/or direct download via the transmitter. CGM data are collected continuously in each phase and at the end of each phase. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Type 2 diabetes of any duration
- Hb A1c ≥ 7% (no upper limit)
- BMI ≥ 30 kg/m2
- Ability to wear CGM (e.g. no dermatological issue precluding device insertion)
- Access to a smartphone device
Key exclusion criteria (5 listed)
- Any insulin use in the past 3 months
- Planned use of insulin in the next 6 months
- Presence of a blood disorder (such as sickle cell anemia) making glycosylated hemoglobin measurement inaccurate
- Current use of a weight loss medication
- Unable or uncomfortable with wearing a CGM device
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 |
|---|---|---|
| Dexcom continuous glucose monitorThe investigational device used in this study is the Dexcom G6 Pro/Personal Continuous Blood Glucose Monitoring system. | Device | Blinded followed by Unblinded |
Primary outcome
Change in Average Glucose Levels as Measured by Continuous Glucose Monitor
Time frame: 0, 30, 60, 90 days
Average glucose on CGM
Change in Time in Range as Measured by Continuous Glucose Monitor
Time frame: 0, 30, 60, 90 days
Time in range is the time spent in the acceptable glucose range between 80-180 mg/dl. This time in range is noted as a proportion of time that the blood glucose is in this range out of the total time. So if the person's glucose is in this range 70% of the time (and out of it 30%), then Time in Range is 70%.
Change in Glucose Variability as Measured by Continuous Glucose Monitor
Time frame: 0, 30, 60, 90 days
Glucose variability on CGM is defined as standard deviation of the all recorded glucose values.
12 secondary outcomes
Change in Hemoglobin A1c From Blood Test
Time frame: 0 and 90 days
Change in Total Cholesterol From Blood Test
Time frame: 0 and 90 days
Change in Low Density Lipoprotein Cholesterol From Blood Test
Time frame: 0 and 90 days
Change in High Density Lipoprotein Cholesterol From Blood Test
Time frame: 0 and 90 days
Change in Triglycerides From Blood Test
Time frame: 0 and 90 days
Change in Body Mass Index From Height and Weight
Time frame: 0 and 90 days
Change in Systolic Blood Pressure From Automated Cuff
Time frame: 0 and 90 days
Change in Diastolic Blood Pressure From Automated Cuff
Time frame: 0 and 90 days
Picture Your Plate Dietary Assessment Questionnaire
Time frame: 0, 90 days
Type 2 Diabetes Distress Screening Scale (T2-DDAS)
Time frame: 0, 90 days
International Physical Activity Questionnaire (IPAQ)
Time frame: 0, 90 days
Glucose Monitoring Satisfaction Survey
Time frame: 90 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 38680050Reed J, Dong T, Eaton E, Friswold J, Porges J, Al-Kindi SG, Rajagopalan S, Neeland IJ. Continuous glucose monitoring for glycaemic control and cardiovascular risk reduction in patients with type 2 diabetes not on insulin therapy: A clinical trial. Diabetes Obes Metab. 2024 Jul;26(7):2881-2889. doi: 10.1111/dom.15608. Epub 2024 Apr 28.
- 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.
Ian Neeland, MD principal investigator
University Hospitals Cleveland Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dexcom continuous glucose monitor in people with Type 2 Diabetes, run by Ian J. Neeland, MD at 1 site 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 5 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: finished, as of the sponsor's last update on 6 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Yes. Results are posted in the registry (first posted 6 Aug 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Change in Average Glucose Levels as Measured by Continuous Glucose Monitor (time frame: 0, 30, 60, 90 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05523362, which also lists 1 linked publication.
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 6 Aug 2024.