Remote Pharmacy Services Plus Continuous Glucose Monitoring in an Underserved Population
The Role of Remote Pharmacy Services With Continuous Glucose Monitoring in an Underserved Population
The purpose of this study is to improve T2DM (type 2 diabetes mellitus) management and health outcomes among underserved patients who receive primary care at a federally qualified health center (FQHC) in Winnebago County, Illinois.
Our aim is to assess the feasibility and preliminary effectiveness of a pilot program combining continuous glucose monitoring (CGM) with monthly telehealth appointments to improve diabetes management in FQHC patients who have uncontrolled T2DM (HbA1c >7%).
Researchers will compare those who receive the intervention (usual in-person care + CGM + 2 telehealth visits with a clinical pharmacist and family medicine resident) with those receiving a CGM in additional to usual care (in-person care + CGM).
Participants will have their HbA1c tested and complete surveys to assess diabetes-related distress and diabetes management self-efficacy at baseline and 3 and 6 months from baseline. This will allow the investigators to raise glucose awareness for all participants utilizing CGM technology while simultaneously determining the necessity of more frequent follow-up than the guideline recommended intervals of 3 months for uncontrolled diabetes in an under-resourced population. This will also allow us to evaluate the feasibility of telehealth in delivering more frequent follow-up care to patients with T2DM.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Type d'étude
Inscription (Réel)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
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-
Illinois
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Rockford, Illinois, États-Unis, 61107
- University of Illinois College of Medicine Rockford
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-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
La description
Inclusion Criteria:
- Patient receiving primary care from the study clinical site
- Uncontrolled T2DM (HbA1c >7%)
- 18 years of age and older
Exclusion Criteria:
- Patients younger than 18 years of age
- Patients in correctional facilities
- Pregnant or lactating women
- Current Continuous Glucose Monitoring device (CGM) users
- Patients with gestational diabetes mellitus or Type 1 diabetes mellitus
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: CGM + telehealth
In addition to usual care for patients with poorly controlled diabetes, participants will receive a CGM plus education on its use and 2 telehealth appointments, 1 month and 2 months from their initial appointment.
The telehealth appointments will be conducted by a clinical pharmacist and family medicine resident physician and will be used to discuss CGM outcomes and treatment planning.
|
Participants will receive CGM supplies for 3 months plus 2 monthly telehealth appointments.
|
|
Comparateur actif: CGM only
In addition to usual care for patients with poorly controlled diabetes, participants will receive a CGM plus education on its use.
|
Participants will receive CGM supplies for 3 months
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
HbA1c
Délai: Enrollment, 3 months, and 6 months
|
Hemoglobin A1c
|
Enrollment, 3 months, and 6 months
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Diabetes-related distress
Délai: Enrollment, 3 months, and 6 months
|
Diabetes-related distress as assessed by the TYPE 2 DIABETES DISTRESS ASSESSMENT SYSTEM (T2-DDAS)
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Enrollment, 3 months, and 6 months
|
|
Diabetes Management Self-Efficacy
Délai: Baseline, 3 months, and 6 months
|
Diabetes management self-efficacy as assessed by the Stanford English Diabetes Self-Management study diabetes self-efficacy questionnaire. Stanford English Diabetes Self-Management study. Study reported in Lorig K, Ritter PL, Villa FJ, Armas J. Community-Based Peer-Led Diabetes Self-Management: A Randomized Trial. The Diabetes Educator 2009; Jul-Aug;35(4):641-51. |
Baseline, 3 months, and 6 months
|
Collaborateurs et enquêteurs
Parrainer
Publications et liens utiles
Publications générales
- Vigersky RA, Fonda SJ, Chellappa M, Walker MS, Ehrhardt NM. Short- and long-term effects of real-time continuous glucose monitoring in patients with type 2 diabetes. Diabetes Care. 2012 Jan;35(1):32-8. doi: 10.2337/dc11-1438. Epub 2011 Nov 18.
- Patel PM, Thomas D, Liu Z, Aldrich-Renner S, Clemons M, Patel BV. Systematic review of disparities in continuous glucose monitoring and insulin pump utilization in the United States: Key themes and evidentiary gaps. Diabetes Obes Metab. 2024 Oct;26(10):4293-4301. doi: 10.1111/dom.15774. Epub 2024 Jul 15.
- Uhl S, Choure A, Rouse B, Loblack A, Reaven P. Effectiveness of Continuous Glucose Monitoring on Metrics of Glycemic Control in Type 2 Diabetes Mellitus: A Systematic Review and Meta-analysis of Randomized Controlled Trials. J Clin Endocrinol Metab. 2024 Mar 15;109(4):1119-1131. doi: 10.1210/clinem/dgad652.
- Wallia A, Agarwal S, Owen AL, Lam EL, Davis K, Bailey SC, DeLacey SE, Pack AP, Espinoza J, Bright D, Eggleston A, Walter E, O'Brien MJ. Disparities in Continuous Glucose Monitoring Among Patients Receiving Care in Federally Qualified Health Centers. JAMA Netw Open. 2024 Nov 4;7(11):e2445316. doi: 10.1001/jamanetworkopen.2024.45316.
- Myers A, Presswala L, Bissoonauth A, Gulati N, Zhang M, Izard S, Kozikowski A, Meyers K, Pekmezaris R. Telemedicine for Disparity Patients With Diabetes: The Feasibility of Utilizing Telehealth in the Management of Uncontrolled Type 2 Diabetes in Black and Hispanic Disparity Patients; A Pilot Study. J Diabetes Sci Technol. 2021 Sep;15(5):1034-1041. doi: 10.1177/1932296820951784. Epub 2020 Aug 29.
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
- Maladies du système endocrinien
- Maladies métaboliques
- Troubles du métabolisme du glucose
- Maladies nutritionnelles et métaboliques
- Diabète sucré, Type 2
- Diabète sucré
- Administration des services de santé
- Prestation de soins de santé
- Techniques d'investigation
- Techniques de laboratoire clinique
- Techniques et procédures de diagnostic
- Diagnostic
- Gestion des soins aux patients
- Analyse chimique du sang
- Tests de chimie clinique
- Techniques de diagnostic, endocrine
- Surveillance, physiologique
- Télémédecine
- Surveillance continue du glucose
Autres numéros d'identification d'étude
- 2264549 - UICOM Rockford
- UIC Diabetes Center Pilot (Autre identifiant: UIC Diabetes Center)
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Description du régime IPD
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Étudie un produit d'appareil réglementé par la FDA américaine
produit fabriqué et exporté des États-Unis.
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