Professional Continuous Glucose Monitoring at the Parkland Diabetes Clinic

Diabete Mellitus Clinical Trial

Official title:

Piloting the Use of Professional Continuous Glucose Monitoring at the Parkland Diabetes Clinic

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT05420714
• Other study ID #: STU-2021-1012
• Status: Withdrawn
• Phase: N/A
• Start date: August 2022
• Est. completion date: September 2023

Study information

• Verified date: July 2022
• Source: University of Texas Southwestern Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: September 2023
• Est. primary completion date: September 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabete Mellitus
• Diabetes Mellitus

Intervention

Device:
• Dexcom Professional Continuous Glucose Monitoring
Patient will be asked to wear the Dexcom Pro-CGM device (small device that can be applied to either the arm or abdomen) for 10 days. They will have 30 minutes initial visit with CDCES to apply the device and review its use and 60 minute final session to review the blood sugar data from the CGM with CDCES and diabetes clinic provider.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Texas Southwestern Medical Center

References & Publications (3)

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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Average change in glycemic control 3 months after Pro-CGM use	Glycemic control will be assessed at baseline and 3 months after intervention by measuring hemoglobin A1c and/or obtaining 14-day average glucose from glucometer or CGM blood sugar data download. These data are collected as part of routine diabetes care at the clinic and will be obtained by chart review.	3 months
Secondary	Average change in hypoglycemia frequency 3 months after Pro-CGM use	Hypoglycemia frequency will be assessed at baseline and 3 months after intervention by reviewing 14-day fingerstick glucose data from glucometer download and comparing the % of blood sugar reading <70 mg/dL at baseline and 3 months after intervention. These data are collected as part of routine diabetes care at the clinic and will be obtained by chart review.	3 months
Secondary	Average change in hyperglycemia frequency 3 months after Pro-CGM use	Hyperglycemia frequency will be assessed at baseline and 3 months after intervention by reviewing 14-day fingerstick glucose data from glucometer download and comparing the % of blood sugar reading >180 mg/dL at baseline and 3 months after intervention. These data are collected as part of routine diabetes care at the clinic and will be obtained by chart review.	3 months
Secondary	Average change in frequency of fingerstick blood glucose checks 3 months after Pro-CGM use	The frequency of fingerstick glucose checks per day will be obtained from glucometer data download, which provides the average # of blood sugar reading per day, at baseline and 3 months after intervention. These data are collected as part of routine diabetes care at the clinic and will be obtained by chart review.	3 months
Secondary	Percentage of positive patient response to the Pro-CGM Questionnaire	The patients are given a questionnaire with 8 "Yes or No" questions about whether or not wearing the CGM has a positive impact on their diabetes self-care practices (diet, exercise, medication adherence, blood glucose monitoring). The percentage of "Yes" responses for the 8 questions will be calculated.	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.