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Professional Continuous Glucose Monitoring at the Parkland Diabetes Clinic

1 juli 2022 uppdaterad av: Felona Gunawan, University of Texas Southwestern Medical Center

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.

Studieöversikt

Status

Indragen

Betingelser

Studietyp

Interventionell

Fas

  • Inte tillämpbar

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

18 år och äldre (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Beskrivning

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

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Hälsovårdsforskning
  • Tilldelning: N/A
  • Interventionsmodell: Enskild gruppuppgift
  • Maskning: Ingen (Open Label)

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: 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.

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Average change in glycemic control 3 months after Pro-CGM use
Tidsram: 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

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Average change in hypoglycemia frequency 3 months after Pro-CGM use
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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.

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Utredare

  • Huvudutredare: Felona Gunawan, MD, University of Texas Southwestern Medical Center

Publikationer och användbara länkar

Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Förväntat)

1 augusti 2022

Primärt slutförande (Förväntat)

1 september 2023

Avslutad studie (Förväntat)

1 september 2023

Studieregistreringsdatum

Först inskickad

11 juni 2022

Först inskickad som uppfyllde QC-kriterierna

11 juni 2022

Första postat (Faktisk)

15 juni 2022

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

6 juli 2022

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

1 juli 2022

Senast verifierad

1 juli 2022

Mer information

Termer relaterade till denna studie

Plan för individuella deltagardata (IPD)

Planerar du att dela individuella deltagardata (IPD)?

NEJ

Läkemedels- och apparatinformation, studiedokument

Studerar en amerikansk FDA-reglerad läkemedelsprodukt

Nej

Studerar en amerikansk FDA-reglerad produktprodukt

Nej

produkt tillverkad i och exporterad från U.S.A.

Nej

Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .

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