Diabetes MellitusNCT03827434
CGM/Clarity Use, Glycemic Control and Clinical Outcomes
A study testing Continuous glucose Monitoring Devices and Clarity Software and Point of Care (POC) blood glucose in people with Diabetes Mellitus and Hyperglycemia, run by University of Maryland, Baltimore at 1 site in United States.
Trial summary
The prevalence of Diabetes Mellitus (DM) is rising and more than 30 million of Americans or 9.4% of the US population has DM. Several large scale randomized clinical trials have found that improved glycemic control reduces the development of complications in patients with DM. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Diabetes Mellitus, Hyperglycemia, Hypoglycemia
- What is being tested?
- Continuous glucose Monitoring Devices and Clarity Software and Point of Care (POC) blood glucose
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Nov 2024to 22 Nov 2024
- 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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- History of Diabetes Mellitus type 2 (DM2) on insulin
- Uncontrolled glycemic control [hyperglycemia defined as Hba1c≥9% in the last 3 months or clinically important hypoglycemia (any reported glucose values less than 54 mg/dl) or severe hypoglycemia (low glucose value that led to a severe event characterized by altered mental status and or physical status requiring assistance)]
Who cannot join
- Subjects that have a history of type 1 DM
- History of type 2 DM, not treated or required to be treated with basal/bolus insulin (i.e diet only, any combination of non insulin antidiabetic drugs only, basal only insulin or bolus/short acting only insulin, or pre-mixed insulins) as these patients are less likely to benefit from CGM use.
- Pregnant patients
- Use of Clarity/ Share or follow applications as telehealth/telemedicine to improve DM management during the last 3 months prior to study entry.
- Extensive skin changes/disease or allergies that preclude wearing the CGM sensor
- Significant psychiatric illness or any mental condition rendering the subject incapable of understanding the objectives and potential consequences of the study.
- Subjects without personal computer and internet network access.
Trial locations and contacts
1 site in 1 country.
United States1 site
Baltimore VA Medical Center
Baltimore, Maryland, 21201
About this study
Official title: Improving Glycemic Control and Clinical Outcomes in Insulin Treated DM2 Patients Managed with CGM Devices and Clarity, a Randomized Clinical Trial
The prevalence of Diabetes Mellitus (DM) is rising and more than 30 million of Americans or 9.4% of the US population has DM. Several large scale randomized clinical trials have found that improved glycemic control reduces the development of complications in patients with DM. However intensive glucose management carries an increased risk of hypoglycemia, a condition that may lead to neurological damage and is associated with increased incidence of cardiovascular events and mortality.
Reducing uncontrolled hyperglycemia and hypoglycemia represents therefore an important objective, as may decrease the direct and indirect impact that diabetes has in our health care system. Achieving optimal glycemic control requires frequent blood glucose monitoring by the patients and recurrent clinic visits,which is often difficult to achieve, as access to typical DM clinic is at least sub optimal.
Read more
m-Health and telemedicine health solutions represent alternative ways to manage patients in the outpatient setting and have been applied in different medical areas, among them in diabetes. However, almost all the telemedicine studies that have been previously performed and recruited DM patients used telemedicine solutions which were based on point of care (POC) finger-stick glucose testing, which are checked infrequently , usually 4-6 times/day.
Continuous glucose monitoring (CGM) devices offer additional ways to monitor blood glucose values and can provide numerous glucose measurements (as frequent as every 5 min). By using software applications, such as the Clarity (Dexcom), which highlights glucose patterns, trends and statistics in standardized reports, providers can make safe recommendations of adjusting DM medications, especially insulin titration. In this randomized clinical trial investigators propose to use CGM devices and Clarity software as a telemedicine platform in order to improve glycemic control and improve health outcomes.
- Conditions
- Diabetes Mellitus, Hyperglycemia, Hypoglycemia
- Being tested
- Continuous glucose Monitoring Devices and Clarity Software, Point of Care (POC) blood glucose
- Medical subject headings
- Diabetes Mellitus, Hyperglycemia, Hypoglycemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Continuous glucose Monitoring Devices and Clarity SoftwareDevice
Patients with DM2 at the intervention group will be managed by Continuous glucose Monitoring and Clarity software
Point of Care (POC) blood glucoseOther
Testing Blood Glucose levels with Point of Care (POC) blood glucose
| Study group | Role | What they receive |
|---|---|---|
| Continuous glucose Monitoring and Clarity | Active comparator | Patients with DM2 and abnormal glycemic control followed by Continuous glucose Monitoring, using Clarity software Receives: Device: Continuous glucose Monitoring Devices and Clarity Software |
| Point of Care Fingerstick Glucose values | Placebo comparator | Patients with DM2 and abnormal glycemic control followed by Point of Care Fingerstick Glucose values Receives: Other: Point of Care (POC) blood glucose |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Hemoglobin A1c (HbA1c) among participants who are managed with Continuous Glucose Monitoring Devices and Clarity versus participants who are managed with Point of Care glucose testing (standard of care)
Measured: Through study completion, 6 months after randomization
Change in the number of hypoglycemic episodes among participants who are managed with Continuous Glucose Monitoring Devices and Clarity versus participants who are managed with Point of Care glucose testing (standard of care)
Measured: Through study completion, 6 months after randomization
Change in the number of hospitalizations among participants who are managed with Continuous Glucose Monitoring Devices and Clarity versus participants who are managed with Point of Care glucose testing (standard of care)
Measured: Through study completion, 6 months after randomization
Change in the number of ED visits among participants who are managed with Continuous Glucose Monitoring Devices and Clarity versus participants who are managed with Point of Care glucose testing (standard of care)
Measured: Through study completion, 6 months after randomization
Change in mortality among participants who are managed with Continuous Glucose Monitoring Devices and Clarity versus participants who are managed with Point of Care glucose testing (standard of care)
Measured: Through study completion, 6 months after randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2019
- Study start22 Nov 2024
- Primary completion22 Nov 2024
- Study completion22 Nov 2024
Why it stopped: We did not receive funding to conduct the study
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by University of Maryland, BaltimoreThe sponsor's other registered studies.
- 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
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Maryland, Baltimore
- Sponsor type
- University, hospital or other
- Collaborators
- Baltimore VA Medical Center
- Responsible party
- Principal investigator, Ilias Spanakis, University of Maryland, Baltimore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03827434
- Sponsor's protocol ID
- HP-00084458
- Status last verified
- Nov 2024
- First submitted
- 28 Jan 2019
- Last updated
- 26 Nov 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: No, only de-identified data are going to be shared.
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Glycemic Control and Clinical Outcomes in Insulin Treated DM2 Patients Managed with CGM Devices and Clarity, a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT03827434
- Acronym / sponsor ID
- HP-00084458
- Conditions
- Diabetes Mellitus, Hyperglycemia, Hypoglycemia
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: We did not receive funding to conduct the study
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of Maryland, BaltimoreUniversity, hospital or other
- Collaborators
- Baltimore VA Medical Center
- Study start
- 22 Nov 2024 (actual)
- Primary completion
- 22 Nov 2024 (actual)
- Study completion
- 22 Nov 2024 (actual)
- First posted
- 1 Feb 2019 (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.
The prevalence of Diabetes Mellitus (DM) is rising and more than 30 million of Americans or 9.4% of the US population has DM. Several large scale randomized clinical trials have found that improved glycemic control reduces the development of complications in patients with DM. However intensive glucose management carries an increased risk of hypoglycemia, a condition that may lead to neurological damage and is associated with increased incidence of cardiovascular events and mortality.
Reducing uncontrolled hyperglycemia and hypoglycemia represents therefore an important objective, as may decrease the direct and indirect impact that diabetes has in our health care system. Achieving optimal glycemic control requires frequent blood glucose monitoring by the patients and recurrent clinic visits,which is often difficult to achieve, as access to typical DM clinic is at least sub optimal.
m-Health and telemedicine health solutions represent alternative ways to manage patients in the outpatient setting and have been applied in different medical areas, among them in diabetes. However, almost all the telemedicine studies that have been previously performed and recruited DM patients used telemedicine solutions which were based on point of care (POC) finger-stick glucose testing, which are checked infrequently , usually 4-6 times/day.
Continuous glucose monitoring (CGM) devices offer additional ways to monitor blood glucose values and can provide numerous glucose measurements (as frequent as every 5 min). By using software applications, such as the Clarity (Dexcom), which highlights glucose patterns, trends and statistics in standardized reports, providers can make safe recommendations of adjusting DM medications, especially insulin titration. In this randomized clinical trial investigators propose to use CGM devices and Clarity software as a telemedicine platform in order to improve glycemic control and improve health outcomes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Continuous glucose Monitoring and Clarity | Active comparator | Device: Continuous glucose Monitoring Devices and Clarity SoftwarePatients with DM2 and abnormal glycemic control followed by Continuous glucose Monitoring, using Clarity software |
| Point of Care Fingerstick Glucose values | Placebo comparator | Other: Point of Care (POC) blood glucosePatients with DM2 and abnormal glycemic control followed by Point of Care Fingerstick Glucose values |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- History of Diabetes Mellitus type 2 (DM2) on insulin
- Uncontrolled glycemic control [hyperglycemia defined as Hba1c≥9% in the last 3 months or clinically important hypoglycemia (any reported glucose values less than 54 mg/dl) or severe hypoglycemia (low glucose value that led to a severe event characterized by altered mental status and or physical status requiring assistance)]
Key exclusion criteria (7 listed)
- Subjects that have a history of type 1 DM
- History of type 2 DM, not treated or required to be treated with basal/bolus insulin (i.e diet only, any combination of non insulin antidiabetic drugs only, basal only insulin or bolus/short acting only insulin, or pre-mixed insulins) as these patients are less likely to benefit from CGM use.
- Pregnant patients
- Use of Clarity/ Share or follow applications as telehealth/telemedicine to improve DM management during the last 3 months prior to study entry.
- Extensive skin changes/disease or allergies that preclude wearing the CGM sensor
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 Devices and Clarity SoftwarePatients with DM2 at the intervention group will be managed by Continuous glucose Monitoring and Clarity software | Device | Continuous glucose Monitoring and Clarity |
| Point of Care (POC) blood glucoseTesting Blood Glucose levels with Point of Care (POC) blood glucose | Other | Point of Care Fingerstick Glucose values |
Primary outcome
Change in Hemoglobin A1c (HbA1c) among participants who are managed with Continuous Glucose Monitoring Devices and Clarity versus participants who are managed with Point of Care glucose testing (standard of care)
Time frame: Through study completion, 6 months after randomization
Change in the number of hypoglycemic episodes among participants who are managed with Continuous Glucose Monitoring Devices and Clarity versus participants who are managed with Point of Care glucose testing (standard of care)
Time frame: Through study completion, 6 months after randomization
Change in the number of hospitalizations among participants who are managed with Continuous Glucose Monitoring Devices and Clarity versus participants who are managed with Point of Care glucose testing (standard of care)
Time frame: Through study completion, 6 months after randomization
Change in the number of ED visits among participants who are managed with Continuous Glucose Monitoring Devices and Clarity versus participants who are managed with Point of Care glucose testing (standard of care)
Time frame: Through study completion, 6 months after randomization
Change in mortality among participants who are managed with Continuous Glucose Monitoring Devices and Clarity versus participants who are managed with Point of Care glucose testing (standard of care)
Time frame: Through study completion, 6 months after randomization
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Nov 2024.
- Individual participant dataSharing planned: No. No, only de-identified data are going to be shared.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Continuous glucose Monitoring Devices and Clarity Software and Point of Care (POC) blood glucose in people with Diabetes Mellitus and Hyperglycemia, run by University of Maryland, Baltimore 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 2 inclusion and 7 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: withdrawn, as of the sponsor's last update on 26 Nov 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. Some participants in this study may receive a placebo. 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 was withdrawn before enrolling participants, so there are no results.
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 Hemoglobin A1c (HbA1c) among participants who are managed with Continuous Glucose Monitoring Devices and Clarity versus participants who are managed with Point of Care glucose testing (standard of care) (time frame: Through study completion, 6 months after randomization). The study lists 5 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 26 Nov 2024.