Health TrialsbyHealthPanel

Continuous Glucose Monitoring (CGM) in an Underserved Population

ConditionsDiabetesDiabetes MellitusDiabetes Type 2
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorTulane University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age 18-75 years

Type 2 diabetes mellitus

HbA1C ≥ 7.5%

At least on 1 insulin injection therapy daily

Disqualifiers

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

Trial design

Design model

Crossover

Treatments tested in this trial

  • Continuous Glucose Monitoring (CGM)

    Device

    Continuous glucose monitors will be placed subcutaneously every 14 days.

Treatment groups

50 Participants
are divided into 2 treatment groups
Group A: Self-Monitoring of Blood Glucose (SMBG)Placebo comparator 1 intervention
Group B: Continuous Glucose Monitoring (CGM)Active comparator 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
Baseline, 6 months

Secondary outcomes

1

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.

Time frame
Baseline, 6 months
2

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.

Time frame
Baseline, 6 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Tulane University

Lead sponsor

Abbott

Collaborator

Source ClinicalTrials.gov
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