Professional Continuous Glucose Monitoring at the Parkland Diabetes Clinic

NCT05420714 | Withdrawn

• 1 other identifier: STU-2021-1012
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Diabete Mellitus

Keywords

continuous glucose monitoring

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Average change in hypoglycemia frequency 3 months after Pro-CGM use

  3 months

• Average change in hyperglycemia frequency 3 months after Pro-CGM use

  3 months

• Average change in frequency of fingerstick blood glucose checks 3 months after Pro-CGM use

  3 months

• Percentage of positive patient response to the Pro-CGM Questionnaire

  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.

Study Arms (1)

Professional CGM Trial

EXPERIMENTAL

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.

Device: Dexcom Professional Continuous Glucose Monitoring

Interventions

Dexcom Professional Continuous Glucose Monitoring DEVICE

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.

Professional CGM Trial

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

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

Sponsors & Collaborators

• University of Texas Southwestern Medical Center: lead

Related 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. doi: 10.1089/dia.2007.0205.

  PMID: 17561790 BACKGROUND

• 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.

  PMID: 23786229 BACKGROUND

• 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.

  PMID: 28667580 BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Felona Gunawan, MD

  University of Texas Southwestern Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: June 11, 2022
• First Posted: June 15, 2022
• Study Start: August 1, 2022
• Primary Completion: September 1, 2023
• Study Completion: September 1, 2023
• Last Updated: July 6, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share