Professional Continuous Glucose Monitoring at the Parkland Diabetes Clinic

The University of Texas System (UT)

Status: Withdrawn

Conditions: Diabete Mellitus

Treatments: Device: Dexcom Professional Continuous Glucose Monitoring

Study type: Interventional

Funder types: Other

Identifiers

NCT05420714

STU-2021-1012

Details and patient eligibility

About

The purpose of this study is to assess whether the short-term use of professional continuous glucose monitoring (Pro-CGM) at the Parkland Diabetes Clinic in selected patients with poorly-controlled diabetes due to hyper- and/or hypoglycemia leads to improvements in patients' glycemic control within 3-6 months, subjective understanding of how food, activity, and medications affect blood sugar levels, and diabetes self-care practices. The study will be a prospective cohort study that assesses patients glycemic control and diabetes self-care practices before and 3-6 months after utilization of a Pro-CGM for 10 days. Glycemic control and diabetes self-care practices will be assessed based on hemoglobin A1c measurements and glucose data download from glucometer and Pro-CGM. A short survey will be administered at the end of the 10 days Pro-CGM use to assess whether the Pro-CGM use had a positive impact on patients' understanding of how different activities affect their blood sugar and diabetes self-care practices.

Parkland Diabetes Clinic serves an ethnically diverse, low socioeconomic patient population, the majority of whom do not have access to diabetes technology like continuous glucose monitoring. CGM measures sugar levels every 5 to 15 minutes and have been shown in clinical studies to improve glycemic control. Establishing a professional CGM program at the clinic will provide short-term access to this technology. One of the main reason for conducting this study is to determine if Pro-CGM would be a useful intervention to integrate into the clinic's routine practice in the future.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

Patients of the Parkland Diabetes Clinic who meets one or more of the following criteria:

• Patients with inaccurate HgbA1c due to conditions that affect red blood cell turnover (examples include but not limited to: anemia, hemoglobinopathies, chronic kidney disease)
• Patients with suspected recurrent hypoglycemia and/or hypoglycemia unawareness
• Patients with persistently elevated HgbA1c >8% despite reported adherence to medications and lifestyle modifications and after assessment by a Certified Diabetes Care and Education Specialist (CDCES)
• Patients with inability to do frequent fingersticks for blood glucose checks due to physical limitations (examples include but not limited to: vision loss, dexterity problems)

Exclusion criteria

• Patients who already have their own personal continuous glucose monitoring device

Trial design

Primary purpose: Health Services Research

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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0 participants in 1 patient group

Professional CGM Trial

Experimental group

Description:

Participants will be asked to wear Dexcom Professional Continuous Glucose Monitoring (Pro-CGM) Device for 10 days. They will have 2 clinic visits with a certified diabetes care and education specialist (CDCES): initial visit for placement of the Pro-CGM and final visit to review the data with CDCES and their diabetes clinic provider. They will be asked to complete a short survey at the end of the 10 days about their experience using the Pro-CGM device and how it impacts their diabetes self-care practices.

Treatment:

Device: Dexcom Professional Continuous Glucose Monitoring