Clinical trial NCT05420714: Professional Continuous Glucose Monitoring at the Parkland Diabetes Clinic
Official title: Piloting the Use of Professional Continuous Glucose Monitoring at the Parkland Diabetes Clinic
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Diabete Mellitus
Keywords: continuous glucose monitoring
Lead sponsor: University of Texas Southwestern Medical Center
Sponsor class: OTHER
First posted: 2022-06-15
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Average change in glycemic control 3 months after Pro-CGM use
timeFrame: 3 months
Secondary outcomes:
measure: Average change in hypoglycemia frequency 3 months after Pro-CGM use
timeFrame: 3 months
measure: Average change in hyperglycemia frequency 3 months after Pro-CGM use
timeFrame: 3 months
measure: Average change in frequency of fingerstick blood glucose checks 3 months after Pro-CGM use
timeFrame: 3 months
measure: Percentage of positive patient response to the Pro-CGM Questionnaire
timeFrame: The survey will be administered at the end of the 10 days Pro-CGM use. The percentage of positive responses will be calculated at the end of study.
Other outcomes:
Locations:
Study officials:
affiliation: University of Texas Southwestern Medical Center
name: Felona Gunawan, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bailey TS, Zisser HC, Garg SK. Reduction in hemoglobin A1C with real-time continuous glucose monitoring: results from a 12-week observational study. Diabetes Technol Ther. 2007 Jun;9(3):203-10. doi: 10.1089/dia.2007.0205.
citation: Leinung M, Nardacci E, Patel N, Bettadahalli S, Paika K, Thompson S. Benefits of short-term professional continuous glucose monitoring in clinical practice. Diabetes Technol Ther. 2013 Sep;15(9):744-7. doi: 10.1089/dia.2013.0027. Epub 2013 Jun 20.
citation: Kesavadev J, Vigersky R, Shin J, Pillai PBS, Shankar A, Sanal G, Krishnan G, Jothydev S. Assessing the Therapeutic Utility of Professional Continuous Glucose Monitoring in Type 2 Diabetes Across Various Therapies: A Retrospective Evaluation. Adv Ther. 2017 Aug;34(8):1918-1927. doi: 10.1007/s12325-017-0576-x. Epub 2017 Jun 30.