Impact of Pharmacist-Led Continuous Glucose Monitoring on Clinical Outcomes in People With Type 2 Diabetes in Primary Care: Protocol for a Prospective Cohort Study
BackgroundContinuous glucose monitoring (CGM) is increasingly being recognized as the new standard of care for glycemic monitoring in people with type 2 diabetes (T2D). However, despite advances in therapeutics and technology, glycemic control remains suboptimal. Team-based a...
Saved in:
| Main Authors: | , , , , , |
|---|---|
| Format: | Article |
| Language: | English |
| Published: |
JMIR Publications
2025-05-01
|
| Series: | JMIR Research Protocols |
| Online Access: | https://www.researchprotocols.org/2025/1/e67014 |
| Tags: |
Add Tag
No Tags, Be the first to tag this record!
|
| _version_ | 1849387326448336896 |
|---|---|
| author | Kevin Cowart Raechel T White Kevin Olson Nicholas W Carris Karim Hanna Janice Zgibor |
| author_facet | Kevin Cowart Raechel T White Kevin Olson Nicholas W Carris Karim Hanna Janice Zgibor |
| author_sort | Kevin Cowart |
| collection | DOAJ |
| description |
BackgroundContinuous glucose monitoring (CGM) is increasingly being recognized as the new standard of care for glycemic monitoring in people with type 2 diabetes (T2D). However, despite advances in therapeutics and technology, glycemic control remains suboptimal. Team-based approaches involving pharmacists, particularly in primary care, have shown to be effective in addressing these shortcomings yet have not been rigorously evaluated in the literature.
ObjectiveHerein we present the protocol for a study that seeks to evaluate the change in hemoglobin A1c (HbA1c) in people with T2D using CGM under a pharmacist-led approach as compared with a pharmacist-led approach using no CGM (only self-monitoring blood glucose with a glucometer). We will also assess changes in CGM-derived glycemic outcomes, health behavior, and safety outcomes among the pharmacist-led CGM cohort.
MethodsThis is a 12-week prospective cohort study in an academic family medicine department. We will enroll adults with T2D and a HbA1c level of ≥8%. Participants in the intervention cohort will wear a CGM sensor (FreeStyle Libre 2) for 12 weeks and receive structured diabetes self-management education and support from a pharmacist. Each participant in the intervention group will have 5 visits with a pharmacist. The primary objective is the between-group difference in change in HbA1c levels from baseline to 12 weeks between the intervention and historical cohort. Secondary objectives include a change in CGM-derived metrics among the intervention group from baseline to 12 weeks, and a change in health behavior via the Summary of Diabetes Self-Care Activities measure from baseline to 12 weeks in the intervention cohort. A CGM survey will also be administered to participants in the intervention cohort to evaluate changes in diet, physical activity, general lifestyle, and medication adherence. Safety endpoints will also be evaluated. The primary and secondary outcomes will be analyzed within and between groups using descriptive statistics, with a multivariable regression analysis conducted as appropriate to adjust for potential known confounding effects.
ResultsThis study was funded in July 2023. We began enrolling participants in December 2024. At the time of writing, 3 participants have been enrolled. It is anticipated that we will conclude this study in December 2025 and expect to disseminate results in March 2026.
ConclusionsResults of this study will further elucidate the role of pharmacist-led CGM in primary care.
Trial RegistrationClinicalTrials.gov NCT06572306; https://clinicaltrials.gov/study/NCT06572306
International Registered Report Identifier (IRRID)PRR1-10.2196/67014 |
| format | Article |
| id | doaj-art-b176bdf139ba4e48ba87abcdab8a9ca4 |
| institution | Kabale University |
| issn | 1929-0748 |
| language | English |
| publishDate | 2025-05-01 |
| publisher | JMIR Publications |
| record_format | Article |
| series | JMIR Research Protocols |
| spelling | doaj-art-b176bdf139ba4e48ba87abcdab8a9ca42025-08-20T03:53:52ZengJMIR PublicationsJMIR Research Protocols1929-07482025-05-0114e6701410.2196/67014Impact of Pharmacist-Led Continuous Glucose Monitoring on Clinical Outcomes in People With Type 2 Diabetes in Primary Care: Protocol for a Prospective Cohort StudyKevin Cowarthttps://orcid.org/0000-0002-6880-1600Raechel T Whitehttps://orcid.org/0000-0002-5929-5590Kevin Olsonhttps://orcid.org/0000-0002-4006-1997Nicholas W Carrishttps://orcid.org/0000-0001-8904-5034Karim Hannahttps://orcid.org/0000-0002-2194-8875Janice Zgiborhttps://orcid.org/0000-0001-6861-332X BackgroundContinuous glucose monitoring (CGM) is increasingly being recognized as the new standard of care for glycemic monitoring in people with type 2 diabetes (T2D). However, despite advances in therapeutics and technology, glycemic control remains suboptimal. Team-based approaches involving pharmacists, particularly in primary care, have shown to be effective in addressing these shortcomings yet have not been rigorously evaluated in the literature. ObjectiveHerein we present the protocol for a study that seeks to evaluate the change in hemoglobin A1c (HbA1c) in people with T2D using CGM under a pharmacist-led approach as compared with a pharmacist-led approach using no CGM (only self-monitoring blood glucose with a glucometer). We will also assess changes in CGM-derived glycemic outcomes, health behavior, and safety outcomes among the pharmacist-led CGM cohort. MethodsThis is a 12-week prospective cohort study in an academic family medicine department. We will enroll adults with T2D and a HbA1c level of ≥8%. Participants in the intervention cohort will wear a CGM sensor (FreeStyle Libre 2) for 12 weeks and receive structured diabetes self-management education and support from a pharmacist. Each participant in the intervention group will have 5 visits with a pharmacist. The primary objective is the between-group difference in change in HbA1c levels from baseline to 12 weeks between the intervention and historical cohort. Secondary objectives include a change in CGM-derived metrics among the intervention group from baseline to 12 weeks, and a change in health behavior via the Summary of Diabetes Self-Care Activities measure from baseline to 12 weeks in the intervention cohort. A CGM survey will also be administered to participants in the intervention cohort to evaluate changes in diet, physical activity, general lifestyle, and medication adherence. Safety endpoints will also be evaluated. The primary and secondary outcomes will be analyzed within and between groups using descriptive statistics, with a multivariable regression analysis conducted as appropriate to adjust for potential known confounding effects. ResultsThis study was funded in July 2023. We began enrolling participants in December 2024. At the time of writing, 3 participants have been enrolled. It is anticipated that we will conclude this study in December 2025 and expect to disseminate results in March 2026. ConclusionsResults of this study will further elucidate the role of pharmacist-led CGM in primary care. Trial RegistrationClinicalTrials.gov NCT06572306; https://clinicaltrials.gov/study/NCT06572306 International Registered Report Identifier (IRRID)PRR1-10.2196/67014https://www.researchprotocols.org/2025/1/e67014 |
| spellingShingle | Kevin Cowart Raechel T White Kevin Olson Nicholas W Carris Karim Hanna Janice Zgibor Impact of Pharmacist-Led Continuous Glucose Monitoring on Clinical Outcomes in People With Type 2 Diabetes in Primary Care: Protocol for a Prospective Cohort Study JMIR Research Protocols |
| title | Impact of Pharmacist-Led Continuous Glucose Monitoring on Clinical Outcomes in People With Type 2 Diabetes in Primary Care: Protocol for a Prospective Cohort Study |
| title_full | Impact of Pharmacist-Led Continuous Glucose Monitoring on Clinical Outcomes in People With Type 2 Diabetes in Primary Care: Protocol for a Prospective Cohort Study |
| title_fullStr | Impact of Pharmacist-Led Continuous Glucose Monitoring on Clinical Outcomes in People With Type 2 Diabetes in Primary Care: Protocol for a Prospective Cohort Study |
| title_full_unstemmed | Impact of Pharmacist-Led Continuous Glucose Monitoring on Clinical Outcomes in People With Type 2 Diabetes in Primary Care: Protocol for a Prospective Cohort Study |
| title_short | Impact of Pharmacist-Led Continuous Glucose Monitoring on Clinical Outcomes in People With Type 2 Diabetes in Primary Care: Protocol for a Prospective Cohort Study |
| title_sort | impact of pharmacist led continuous glucose monitoring on clinical outcomes in people with type 2 diabetes in primary care protocol for a prospective cohort study |
| url | https://www.researchprotocols.org/2025/1/e67014 |
| work_keys_str_mv | AT kevincowart impactofpharmacistledcontinuousglucosemonitoringonclinicaloutcomesinpeoplewithtype2diabetesinprimarycareprotocolforaprospectivecohortstudy AT raecheltwhite impactofpharmacistledcontinuousglucosemonitoringonclinicaloutcomesinpeoplewithtype2diabetesinprimarycareprotocolforaprospectivecohortstudy AT kevinolson impactofpharmacistledcontinuousglucosemonitoringonclinicaloutcomesinpeoplewithtype2diabetesinprimarycareprotocolforaprospectivecohortstudy AT nicholaswcarris impactofpharmacistledcontinuousglucosemonitoringonclinicaloutcomesinpeoplewithtype2diabetesinprimarycareprotocolforaprospectivecohortstudy AT karimhanna impactofpharmacistledcontinuousglucosemonitoringonclinicaloutcomesinpeoplewithtype2diabetesinprimarycareprotocolforaprospectivecohortstudy AT janicezgibor impactofpharmacistledcontinuousglucosemonitoringonclinicaloutcomesinpeoplewithtype2diabetesinprimarycareprotocolforaprospectivecohortstudy |