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- Klinische Studie NCT05420714
Professional Continuous Glucose Monitoring at the Parkland Diabetes Clinic
Piloting the Use of Professional Continuous Glucose Monitoring at the Parkland Diabetes Clinic
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.
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
Studientyp
Phase
- Unzutreffend
Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
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
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Versorgungsforschung
- Zuteilung: N / A
- Interventionsmodell: Einzelgruppenzuweisung
- Maskierung: Keine (Offenes Etikett)
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
---|---|
Experimental: Professional CGM Trial
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.
|
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.
|
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
---|---|---|
Average change in glycemic control 3 months after Pro-CGM use
Zeitfenster: 3 months
|
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
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
---|---|---|
Average change in hypoglycemia frequency 3 months after Pro-CGM use
Zeitfenster: 3 months
|
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
|
Average change in hyperglycemia frequency 3 months after Pro-CGM use
Zeitfenster: 3 months
|
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
|
Average change in frequency of fingerstick blood glucose checks 3 months after Pro-CGM use
Zeitfenster: 3 months
|
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
|
Percentage of positive patient response to the Pro-CGM Questionnaire
Zeitfenster: 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.
|
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.
|
Mitarbeiter und Ermittler
Ermittler
- Hauptermittler: Felona Gunawan, MD, University of Texas Southwestern Medical Center
Publikationen und hilfreiche Links
Allgemeine Veröffentlichungen
- 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.
- 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.
- 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.
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Voraussichtlich)
Primärer Abschluss (Voraussichtlich)
Studienabschluss (Voraussichtlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- STU-2021-1012
Plan für individuelle Teilnehmerdaten (IPD)
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Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
Produkt, das in den USA hergestellt und aus den USA exportiert wird
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