Diabetes Mellitus, Type 2NCT03805412
Continuous Glucose Monitoring in Diabetes and Prediabetes
A study testing DEXCOM G6 RT-CGM in people with Diabetes Mellitus, Type 2 and PreDiabetes, run by Nicole Ehrhardt, MD at 1 site in United States.
Trial summary
Evaluate the use of brief serial real time continuous monitoring (RT-CGM) as a behavior modification tool in obese patients with prediabetes and diabetes. After receiving RT-CGM, nutrition and exercise education, participants will be able to monitor their blood sugar in real time for 2 sessions . Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Diabetes Mellitus, Type 2, PreDiabetes, Obesity
- What is being tested?
- DEXCOM G6 RT-CGM
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Jan 2019to 3 Jul 2020
- 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 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age 18-55
- Prediabetes (A1c 6.0-6.4) or Diabetes (A1c 7.0-10)
- BMI ≥ 30 kg/m2
- Willing to wear pedometer during study period
- Able to walk 2 city blocks at baseline without assistance (self-reported)
- Reading level at least 6th grade in English
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- Expected to remain in local community for at least 4 months
- Either is not treated with or has been on a stable treatment regimen of any of the following medications for a minimum of 3 months prior to Visit 1 (Screening/Enrollment):
- Sulfonylureas
- Biguanidine
- Thyroid replacement therapy
- Glp-1 agonists
- Sodium-glucose co-transporters
- Basal insulin
- Thiazolidinediones
- Hormone replacement therapy (female subjects) estrogen/progesterone products
- Oral contraceptives/birth control (female subjects)
- Antidepressant agents (SSRIs, Paxil, Prozac, Celexa, Zoloft, etc.)
- Is able to read, understand, and sign the Informed Consent Form (ICF) and if applicable, an Authorization to Use and Disclose Protected Health Information form (consistent with Health Insurance Portability and Accountability Act of 1996 [HIPAA] legislation), communicate with the investigator, and understand and comply with protocol requirements.
Who cannot join
- Women who are pregnant, lactating, planning to become pregnant
- Subjects who are taking amphetamines, anabolic, or weight-reducing agents
- Contraindications to moderate exercise
- Pre-prandial insulin
- On any antipsychotic medication or history of schizophrenia or bipolar disorder
- Daily use of any form of steroid medication (oral, inhaled, injected) within the last 3 months
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- Active wounds or recent surgery within 3 months
- Inflammatory disease, or chronic and current use of anti-inflammatory drugs or narcotics
- Active cardiovascular diseases within 12 months of Visit 1, such as myocardial infarction, clinically significant arrhythmia, unstable angina, coronary artery bypass surgery, or angioplasty; or are expected to require coronary artery bypass surgery or angioplasty during the course of the study
- Presence or history of severe congestive heart failure (New York Heart Association Class IV [CCNYHA 1994])
- Has evidence of current abuse of drugs or alcohol or a history of abuse that, in the investigator's opinion, would cause the individual to be noncompliant
- Enrolled in another weight loss program
- Already receiving continuous glucose monitoring (CGM)
Trial locations and contacts
1 site in 1 country.
United States1 site
GWU Medical Faculty Associates
Washington D.C., District of Columbia, 20037
About this study
Official title: A Pilot Study on the Use of Real-Time Continuous Glucose Monitoring (RT-CGM) as an Educational Tool for Patients With Prediabetes and Diabetes
Evaluate the use of brief serial real time continuous monitoring (RT-CGM) as a behavior modification tool in obese patients with prediabetes and diabetes. After receiving RT-CGM, nutrition and exercise education, participants will be able to monitor their blood sugar in real time for 2 sessions . Education on how to interpret CGM in the setting of food choices and exercise coupled with nutrition and exercise information should lead to improved weight and other nutritional and exercise changes.
- Conditions
- Diabetes Mellitus, Type 2, PreDiabetes, Obesity
- Being tested
- DEXCOM G6 RT-CGM
- Medical subject headings
- Diabetes Mellitus, Type 2, Prediabetic State, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DEXCOM G6 RT-CGMDevice
CGM is a way to measure glucose levels in real-time. A tiny electrode called a glucose sensor is inserted under the skin to measure glucose levels in tissue fluid. A small plastic piece of tube remains inserted in the skin. It is connected to a transmitter that sits on top of the skin. It is approved for use on the abdomen for 10 days. It either records the sugars downloaded in the clinic (blinded part of the study) or it sends the information via wireless radio frequency to a monitoring/ display device or to a cellular phone so participants can see data. DEXCOM G6 is FDA approved for use in patients with diabetes and will be used in accordance with instructions as approved for diabetes.
| Study group | Role | What they receive |
|---|---|---|
| DEXCOM G6 RT-CGM | Active comparator | These participants will wear blinded continuous glucose monitoring for 10 days at baseline and 14 weeks. They will also complete real-time continuous glucose monitoring (RT-CGM) for 10 days at 2 weeks and 6 weeks. They will receive Nutrition and exercise counseling at week 2 and 6. They will also receive additional training on continuous glucose monitoring. Receives: Device: DEXCOM G6 RT-CGM |
| Blinded CGM | No intervention | These participants will have blinded continuous glucose monitoring(CGM) at the baseline and last 14 weeks. They will not wear continuous glucose monitoring at the interim appointments. They will receive 2 session of nutrition and exercise counseling at week 2 and 6. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent Change in BMI From Baseline to 14 Weeks
weight and height will be combined to report % change BMI in kg/m^2 at 14 weeks
Measured: 14 weeks
Percent Body Fat Change at 14 Weeks
Percent by Tanita scale
Measured: 14 weeks
Secondary outcomes (5)
Questionnaire: Experiences With Glucose Monitoring (CGM) Diabetes
Experiences of CGM @Joslin 2009 scale of (5) strongly agree or (1) strongly disagree about statements/questions that measured the amount of satisfaction that was derived from continuous glucose monitoring. The larger the score the more satisfied participants were with CGM. 100 being the max score and 20 being the min score
Measured: 14 weeks
Mean Glucose Change at 14 Weeks
average glucose during 10 days of wearing continuous glucose monitoring (CGM) at baseline and 14 weeks
Measured: 14 weeks
Food Frequency Change in Score at 14 Weeks
Starting The Conversation (STC) is an eight-item simplified food frequency instrument/questionnaire a max score of 16 indicates poor food choices and a minimum score of 0 indicates good food choices. Results reported is change from baseline score with a negative score being a marker of improvement in food choices and a positive score being worsening of food choices
Measured: 14 weeks
Change in Minutes Walked Per Week at 14 Weeks
The International Physical Activity Questionnaire(short) is as validated questionnaire which asks the time in minutes or hours in last week you do vigorous exercise, moderate intensity exercise, walking and sitting
Measured: 14 weeks
MAGE Mean Amplitude of Glycemic Excursion
this is calculation of variance of glucose for CGM
Measured: 14 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2019
- Study start10 Jan 2019
- Primary completion3 Jul 2020
- Study completion3 Jul 2020
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.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nicole Ehrhardt, MD
- Sponsor type
- University, hospital or other
- Collaborators
- DexCom, Inc.
- Responsible party
- Sponsor-investigator, Nicole Ehrhardt, MD, George Washington University
- Investigators
- Nicole Ehrhardt, MD, Principal investigator, George Washington University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03805412
- Sponsor's protocol ID
- 180609
- Status last verified
- Feb 2023
- First submitted
- 19 Dec 2018
- Last updated
- 1 Mar 2023
- Results posted
- Yes, on ClinicalTrials.gov
- 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 1 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study on the Use of Real-Time Continuous Glucose Monitoring (RT-CGM) as an Educational Tool for Patients With Prediabetes and Diabetes
- ClinicalTrials.gov ID
- NCT03805412
- Acronym / sponsor ID
- 180609
- Conditions
- Diabetes Mellitus, Type 2, PreDiabetes, Obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Nicole Ehrhardt, MDUniversity, hospital or other
- Collaborators
- DexCom, Inc.
- Study start
- 10 Jan 2019 (actual)
- Primary completion
- 3 Jul 2020 (actual)
- Study completion
- 3 Jul 2020 (actual)
- First posted
- 15 Jan 2019 (actual)
- Results
- Posted 1 Mar 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Evaluate the use of brief serial real time continuous monitoring (RT-CGM) as a behavior modification tool in obese patients with prediabetes and diabetes. After receiving RT-CGM, nutrition and exercise education, participants will be able to monitor their blood sugar in real time for 2 sessions . Education on how to interpret CGM in the setting of food choices and exercise coupled with nutrition and exercise information should lead to improved weight and other nutritional and exercise changes.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DEXCOM G6 RT-CGM | Active comparator | Device: DEXCOM G6 RT-CGMThese participants will wear blinded continuous glucose monitoring for 10 days at baseline and 14 weeks. They will also complete real-time continuous glucose monitoring (RT-CGM) for 10 days at 2 weeks and 6 weeks. They will receive Nutrition and exercise counseling at week 2 and 6. They will also receive additional training on continuous glucose monitoring. |
| Blinded CGM | No intervention | –These participants will have blinded continuous glucose monitoring(CGM) at the baseline and last 14 weeks. They will not wear continuous glucose monitoring at the interim appointments. They will receive 2 session of nutrition and exercise counseling at week 2 and 6. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (19 listed)
- Age 18-55
- Prediabetes (A1c 6.0-6.4) or Diabetes (A1c 7.0-10)
- BMI ≥ 30 kg/m2
- Willing to wear pedometer during study period
- Able to walk 2 city blocks at baseline without assistance (self-reported)
Key exclusion criteria (13 listed)
- Women who are pregnant, lactating, planning to become pregnant
- Subjects who are taking amphetamines, anabolic, or weight-reducing agents
- Contraindications to moderate exercise
- Pre-prandial insulin
- On any antipsychotic medication or history of schizophrenia or bipolar disorder
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 G6 RT-CGMCGM is a way to measure glucose levels in real-time. A tiny electrode called a glucose sensor is inserted under the skin to measure glucose levels in tissue fluid. A small plastic piece of tube remains inserted in the skin. It is connected to a transmitter that sits on top of the skin. It is approved for use on the abdomen for 10 days. It either records the sugars downloaded in the clinic (blinded part of the study) or it sends the information via wireless radio frequency to a monitoring/ display device or to a cellular phone so participants can see data. DEXCOM G6 is FDA approved for use in patients with diabetes and will be used in accordance with instructions as approved for diabetes. | Device | DEXCOM G6 RT-CGM |
Primary outcome
Percent Change in BMI From Baseline to 14 Weeks
Time frame: 14 weeks
weight and height will be combined to report % change BMI in kg/m^2 at 14 weeks
Percent Body Fat Change at 14 Weeks
Time frame: 14 weeks
Percent by Tanita scale
5 secondary outcomes
Questionnaire: Experiences With Glucose Monitoring (CGM) Diabetes
Time frame: 14 weeks
Mean Glucose Change at 14 Weeks
Time frame: 14 weeks
Food Frequency Change in Score at 14 Weeks
Time frame: 14 weeks
Change in Minutes Walked Per Week at 14 Weeks
Time frame: 14 weeks
MAGE Mean Amplitude of Glycemic Excursion
Time frame: 14 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Mar 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
Nicole Ehrhardt, MD principal investigator
George Washington University
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 G6 RT-CGM in people with Diabetes Mellitus, Type 2 and PreDiabetes, run by Nicole Ehrhardt, 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 19 inclusion and 13 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 1 Mar 2023. 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 1 Mar 2023). 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?
Percent Change in BMI From Baseline to 14 Weeks (time frame: 14 weeks). The study lists 2 primary outcomes in all. 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 1 Mar 2023.