DiabetesNCT07135531
Continuous Glucose Monitoring (CGM) in an Underserved Population
A study testing Continuous Glucose Monitoring (CGM) in people with Diabetes and Diabetes Mellitus, run by Tulane University at 1 site in United States.
Trial summary
The investigators aim is to conduct a randomized clinical trial in an underserved population who are either uninsured or on Medicaid and taking at least one injection of insulin daily. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Diabetes, Diabetes Mellitus, Diabetes Type 2
- What is being tested?
- Continuous Glucose Monitoring (CGM)
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Mar 2026to Jul 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18-75 years
- Type 2 diabetes mellitus
- HbA1C ≥ 7.5%
- At least on 1 insulin injection therapy daily
- Patients established with primary care clinic or endocrinology clinic or diabetes clinics in the New Orleans and surrounding areas
- Patients with Medicaid or free care or uninsured
- Patients must be able to speak and understand English and be capable of providing informed consent to participate in the study
Who cannot join
- Type 1 diabetes mellitus
- Currently on CGM or using insulin pump
- Advanced renal disease or Estimated Glomerular Filtration Rate (eGFR) <40
- Serious co-morbidities which in the investigator's opinion, will make it challenging for patients to participate
- The patient has been diagnosed with end-stage renal disease, is on dialysis, or has had a kidney transplant, Hemoglobinopathies, iron therapy or other condition that interferes with HbA1c measurement
- Pregnant
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University Medical Center
New Orleans, Louisiana, 70112
Neha Upadhyay, BDS,MPH, 504-988-9803, nupadhyay@tulane.edu
Ayitevi Agbodji, MD,MPH&TM, 504-988-9839, aagbodji@tulane.edu
About this study
Official title: Continuous Glucose Monitoring in an Underserved Population: Impact on Glucose Control, Patient Reported Outcomes, Healthcare Utilization, and Long Term Complications
The investigators aim is to conduct a randomized clinical trial in an underserved population who are either uninsured or on Medicaid and taking at least one injection of insulin daily. The investigators believe that this study will lead to considerable alleviation of health disparities and provide better care for an underserved population. This will be a pilot study to evaluate the feasibility of such a trial in this population before doing a larger multicenter trial.
Read the detailed description
This study is a randomized open label trial with study participants being randomized to either a continuous glucose monitoring group (intervention) or a self-monitoring group (control) after a period of two-week run-in and followed for 6 months. All participants regardless of assignment will be provided diabetes education. Participants randomized to the self-monitoring group will be given an opportunity to wear the CGM sensor for 3 months at the conclusion of the 6-month follow-up as an optional follow-up.
- Conditions
- Diabetes, Diabetes Mellitus, Diabetes Type 2
- Being tested
- Continuous Glucose Monitoring (CGM)
- Keywords
- Medicaid, Underinsured, Continuous glucose monitoring, Uninsured
- Medical subject headings
- Diabetes Mellitus, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Continuous Glucose Monitoring (CGM)Device
Continuous glucose monitors will be placed subcutaneously every 14 days.
| Study group | Role | What they receive |
|---|---|---|
| Self-Monitoring of Blood Glucose (SMBG) | Placebo comparator | The study participants will be randomized to the self-monitoring group (control) after a period of two-week run-in and followed for 6 months. They will be given an opportunity to wear the CGM sensor for 3 months at the conclusion of the 6-month follow-up as an optional follow-up. Receives: Device: Continuous Glucose Monitoring (CGM) |
| Continuous Glucose Monitoring (CGM) | Active comparator | The study participants will be randomized to the continuous glucose monitoring group (intervention). 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 Glycated hemoglobin (HbA1c) between baseline and 6-month visits for both groups
The investigators will take blood samples at baseline and at the 6 months visit to measure the HbA1c levels. Change in the level of HbA1c at 6 months will be compared between the 2 groups to assess the outcome.
Measured: Baseline, 6 months
Secondary outcomes (2)
Change in Time in Range (TIR)
TIR is a percentage of time that a person with diabetes spends within their target blood glucose range. The investigators will review the data from the CGM devices and assess if there are any changes in the TIR between the 2 groups at baseline and at 6 months. The higher the percentage is for TIR, the better the blood glucose control is for patients.
Measured: Baseline, 6 months
Change in documented hypoglycemia <70 mg/ dl and severe hypoglycemia - <54 mg/dl
The investigators will measure the change in documented hypoglycemia and severe hypoglycemia in patients in both groups at baseline and at 6 months. The lower the numbers of the hypoglycemia incidences, the better the outcome is.
Documented hypoglycemia and severe hypoglycemia will be measured as a percentage of time that a person with diabetes below their target blood glucose range.
Measured: Baseline, 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2025
- Study start19 Mar 2026
- Primary completionJul 2027 (estimated)
- Study completionJul 2027 (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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tulane University
- Sponsor type
- University, hospital or other
- Collaborators
- Abbott
- Responsible party
- Sponsor
- Investigators
- Shaveta Gupta, MD, Principal investigator, Tulane University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07135531
- Sponsor's protocol ID
- 2024-1872
- Status last verified
- May 2026
- First submitted
- 14 Aug 2025
- Last updated
- 5 May 2026
- 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 5 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Continuous Glucose Monitoring in an Underserved Population: Impact on Glucose Control, Patient Reported Outcomes, Healthcare Utilization, and Long Term Complications
- ClinicalTrials.gov ID
- NCT07135531
- Acronym / sponsor ID
- 2024-1872
- Conditions
- Diabetes, Diabetes Mellitus, Diabetes Type 2
- Keywords
- Medicaid, Underinsured, Continuous glucose monitoring, Uninsured
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Tulane UniversityUniversity, hospital or other
- Collaborators
- Abbott
- Study start
- 19 Mar 2026 (actual)
- Primary completion
- Jul 2027 (estimated)
- Study completion
- Jul 2027 (estimated)
- First posted
- 22 Aug 2025 (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 investigators aim is to conduct a randomized clinical trial in an underserved population who are either uninsured or on Medicaid and taking at least one injection of insulin daily. The investigators believe that this study will lead to considerable alleviation of health disparities and provide better care for an underserved population. This will be a pilot study to evaluate the feasibility of such a trial in this population before doing a larger multicenter trial.
Detailed description
This study is a randomized open label trial with study participants being randomized to either a continuous glucose monitoring group (intervention) or a self-monitoring group (control) after a period of two-week run-in and followed for 6 months. All participants regardless of assignment will be provided diabetes education. Participants randomized to the self-monitoring group will be given an opportunity to wear the CGM sensor for 3 months at the conclusion of the 6-month follow-up as an optional follow-up.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Self-Monitoring of Blood Glucose (SMBG) | Placebo comparator | Device: Continuous Glucose Monitoring (CGM)The study participants will be randomized to the self-monitoring group (control) after a period of two-week run-in and followed for 6 months. They will be given an opportunity to wear the CGM sensor for 3 months at the conclusion of the 6-month follow-up as an optional follow-up. |
| Continuous Glucose Monitoring (CGM) | Active comparator | Device: Continuous Glucose Monitoring (CGM)The study participants will be randomized to the continuous glucose monitoring group (intervention). |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age 18-75 years
- Type 2 diabetes mellitus
- HbA1C ≥ 7.5%
- At least on 1 insulin injection therapy daily
- Patients established with primary care clinic or endocrinology clinic or diabetes clinics in the New Orleans and surrounding areas
Key exclusion criteria (6 listed)
- Type 1 diabetes mellitus
- Currently on CGM or using insulin pump
- Advanced renal disease or Estimated Glomerular Filtration Rate (eGFR) <40
- Serious co-morbidities which in the investigator's opinion, will make it challenging for patients to participate
- The patient has been diagnosed with end-stage renal disease, is on dialysis, or has had a kidney transplant, Hemoglobinopathies, iron therapy or other condition that interferes with HbA1c measurement
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)Continuous glucose monitors will be placed subcutaneously every 14 days. | Device | Continuous Glucose Monitoring (CGM), Self-Monitoring of Blood Glucose (SMBG) |
Primary outcome
Change in Glycated hemoglobin (HbA1c) between baseline and 6-month visits for both groups
Time frame: Baseline, 6 months
The investigators will take blood samples at baseline and at the 6 months visit to measure the HbA1c levels. Change in the level of HbA1c at 6 months will be compared between the 2 groups to assess the outcome.
2 secondary outcomes
Change in Time in Range (TIR)
Time frame: Baseline, 6 months
Change in documented hypoglycemia <70 mg/ dl and severe hypoglycemia - <54 mg/dl
Time frame: Baseline, 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2026.
- 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.
Shaveta Gupta, MD principal investigator
Tulane 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 Continuous Glucose Monitoring (CGM) in people with Diabetes and Diabetes Mellitus, run by Tulane University 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 7 inclusion and 6 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: looking for participants now, as of the sponsor's last update on 5 May 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Neha Upadhyay, BDS,MPH (5049889803, nupadhyay@tulane.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Glycated hemoglobin (HbA1c) between baseline and 6-month visits for both groups (time frame: Baseline, 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 5 May 2026; AzTrials last refreshed its copy on 7 Nov 2026.