Evaluation of Pharmacist Intervention for Individuals With Uncontrolled Type 2 Diabetes

NCT05442840 | Active Not Recruiting

• 1 other identifier: HS25460 (B2022:031)
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Type 2 diabetes is a chronic disease that can lead to a number of complications if uncontrolled and there is a projected increase of 33% patients living with diabetes over the next 10 years. There can be improvements to modifiable risk factors such as diet and exercise, in addition to medications. Treatment often involves a multidisciplinary approach with a physician, endocrinologist, dietitian, pharmacist and other support health professionals as required. This study will evaluate the effects of the pharmacists (or pharmD interns) intervention, looking at changes to the patients HbA1C, which is a measure of the patients blood glucose control over the previous 3 months as well as the patients understanding and comfort with managing their own diabetes via participant survey.

Conditions

Diabetes Type 2

Outcome Measures

Primary Outcomes (1)

• Change in Baseline Hemoglobin A1C (HbA1C) at 10 months

  Measure of blood glucose control at the lab

  baseline and through study completion at 10 months approximately

Secondary Outcomes (4)

• Participant Survey

  baseline and through study completion at 10 months approximately

• Modifiable Risk Factors -Cholesterol Level

  baseline and through study completion at 10 months approximately

• Modifiable Risk Factor - Body Mass Index

  baseline and through study completion at 10 months approximately

• Modifiable Risk Factor - Blood Pressure

  baseline and through study completion at 10 months approximately

Study Arms (2)

Control Arm

NO INTERVENTION

The participants in this arm will receive standard of care from their physician as they would have been doing previously. This still may involve blood work, referrals to other health providers (except pharmacist) and medication adjustments driven by the pharmacist.

Pharmacist Intervention Arm

ACTIVE COMPARATOR

The participants in this arm will receive standard of care from their physician in addition to pharmacist intervention. The pharmacist or pharmD intern leads the diabetes care for the patient typically, conducting a medication review, recommending medication changes, frequent follow up and requesting blood work and providing referrals to other health care providers as needed,which is standard care

Combination Product: Behavioral and drugs already approved and available for diabetes management

Interventions

Behavioral and drugs already approved and available for diabetes management COMBINATION_PRODUCT

Pharmacists will review the patients information and medical history as well as drug coverage to discuss preferred treatment options to manage diabetes based on recommendations from Diabetes Canada treatment guidelines; all drugs have been approved and are available on the market; pharmacists will offer frequent follow up and provide basic diabetes education to the patient at each follow up appointment

Pharmacist Intervention Arm

Eligibility Criteria

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

You may qualify if:

• Patients whose primary care physician is within the Portage Clinic
• Adults (age 18 and older) with type 2 diabetes with HbA1C 10 % or above
• Patients whom have not had previous clinical pharmacist directed intervention
• Agree to participate in the study, including frequent follow up, blood glucose home monitoring as directed and repeat lab work
• Willing to consider medication adjustments as deemed appropriate
• Willing to review and sign the Research Participant Information and Informed Consent Form

You may not qualify if:

• Patients less than 18 years of age
• Patients with type 1 diabetes, pre-diabetes or gestational diabetes (or whom are pregnant)
• Patients whom have had recent or ongoing clinical pharmacist directed intervention or intensive health care professional monitoring and guidance
• Patients with HbA1C less than 10%
• Patients whom refuse medication adjustments
• Patients with severe renal impairment or receiving dialysis treatments

Sponsors & Collaborators

• University of Manitoba: lead

Study Sites (1)

Portage Clinic

Portage la Prairie, Manitoba, R1N 3V5, Canada

Location

Related Publications (12)

• APDS Diabetes Knowledge Questionnaire - Baker. (n.d.). Retrieved March 22, 2022, from https://www.baker.edu.au/-/media/documents/impact/ausdiab/questionnaires/ausdiab-diabetes-knowledge-questionnaire-2004.pdf?la=en

  BACKGROUND

• Schmitt A, Gahr A, Hermanns N, Kulzer B, Huber J, Haak T. The Diabetes Self-Management Questionnaire (DSMQ): development and evaluation of an instrument to assess diabetes self-care activities associated with glycaemic control. Health Qual Life Outcomes. 2013 Aug 13;11:138. doi: 10.1186/1477-7525-11-138.

  PMID: 23937988 BACKGROUND

• 36-Item Short form survey instrument (SF-36). RAND Corporation. (n.d.). Retrieved March 21, 2022, from https://www.rand.org/health-care/surveys_tools/mos/36-item-short-form/survey-instrument.html

  BACKGROUND

• Jacobson, A. M., & Diabetes Control & Complications Trial Research Group. (1994). The Diabetes Quality of Life Measure. In C. Bradley (Ed.), Handbook of psychology and diabetes: A guide to psychological measurement in diabetes research and practice (pp. 65-87). Harwood Academic Publishers/Gordon.

  BACKGROUND

• Bradley C: The Diabetes Treatment Satisfaction Questionnaire: DTSQ. In Handbook of Psychology and Diabetes: a guide to psychological measurement in diabetes research and practice. Edited by: Bradley C. Chur, Switzerland: Harwood Academic Publishers; 1994:111-132

  BACKGROUND

• Syarifuddin S, Nasution A, Dalimunthe A, Khairunnisa. Impact of Pharmacist Intervention on Improving the Quality of Life of Patients with Type 2 Diabetes Mellitus. Open Access Maced J Med Sci. 2019 Apr 29;7(8):1401-1405. doi: 10.3889/oamjms.2019.140. eCollection 2019 Apr 30.

  PMID: 31110593 BACKGROUND

• Bukhsh A, Nawaz MS, Ahmed HS, Khan TM. A randomized controlled study to evaluate the effect of pharmacist-led educational intervention on glycemic control, self-care activities and disease knowledge among type 2 diabetes patients: A consort compliant study protocol. Medicine (Baltimore). 2018 Mar;97(12):e9847. doi: 10.1097/MD.0000000000009847.

  PMID: 29561461 BACKGROUND

• Abdulrhim S, Awaisu A, Ibrahim MIM, Diab MI, Hussain MAM, Al Raey H, Ismail MT, Sankaralingam S. Impact of pharmacist-involved collaborative care on diabetes management in a primary healthcare setting using real-world data. Int J Clin Pharm. 2022 Feb;44(1):153-162. doi: 10.1007/s11096-021-01327-x. Epub 2021 Oct 12.

  PMID: 34637104 BACKGROUND

• Stading, J., Herrmann, J., Walters, R., Destache, C., Chock, A. (2009). Impact of Pharmacist Intervention on Diabetes Patients in an Ambulatory Setting. Diabetes Spectrum, Volume 22, Number 4, (241-246). https://diabetesjournals.org/spectrum/article/22/4/241/2441/Impact-of-Pharmacist-Intervention-on-Diabetes

  BACKGROUND

• Jennings DL, Ragucci KR, Chumney EC, Wessell AM. Impact of clinical pharmacist intervention on diabetes related quality-of-life in an ambulatory care clinic. Pharm Pract (Granada). 2007 Oct;5(4):169-73. doi: 10.4321/s1886-36552007000400005.

  PMID: 25170354 BACKGROUND

• Butt M, Mhd Ali A, Bakry MM, Mustafa N. Impact of a pharmacist led diabetes mellitus intervention on HbA1c, medication adherence and quality of life: A randomised controlled study. Saudi Pharm J. 2016 Jan;24(1):40-8. doi: 10.1016/j.jsps.2015.02.023. Epub 2015 Mar 6.

  PMID: 26903767 BACKGROUND

• Shane-McWhorter L, McAdam-Marx C, Lenert L, Petersen M, Woolsey S, Coursey JM, Whittaker TC, Hyer C, LaMarche D, Carroll P, Chuy L. Pharmacist-provided diabetes management and education via a telemonitoring program. J Am Pharm Assoc (2003). 2015 Sep-Oct;55(5):516-26. doi: 10.1331/JAPhA.2015.14285.

  PMID: 26359961 BACKGROUND

Related Links

• Diabetes Canada (2022, March). Diabetes in Manitoba: Backgrounder. Ottawa: Diabetes Canada; 2021.
• Canadian Pharmacists Association, (2022, March). More and more Canadians say pharmacists play essential role in Canada's health care system, 2017.
• The Canadian Diabetes Association. (2018). Diabetes Canada Clinical Practice Guidelines. Resources for People with Diabetes, Managing my Diabetes - My Action Plan.
• The Canadian Diabetes Association. (2015). Diabetes Canada Clinical Practice Guidelines. Patient resources, Medication sheet: SGLT2 Inhibitors
• The Canadian Diabetes Association. (2018). Diabetes Canada Clinical Practice Guidelines. Quick Reference Guide.
• The Canadian Diabetes Association. (2017). Tools and Resources, Insulin Prescription
• The Canadian Diabetes Association. (2018). Diabetes Canada Clinical Practice Guidelines. Tools and Resources, Insulin pen start checklist
• The Canadian Diabetes Association. (2018). Appendix 7: Therapeutic Considerations for Renal Impairment. (2018). Canadian Journal of Diabetes, 42
• The Canadian Diabetes Association. (2020). 2020 Chapter Updates: Pharmacologic Glycemic Management of Type 2 Diabetes in Adults: 2020 Update
• Health Canada. (April 2020). Side Effect Reporting Form
• The Canadian Diabetes Association. (2018). Appendix 6: Types of insulin. (2018). Canadian Journal of Diabetes, 42

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Masking Details: The care provider (physician) will be aware the patient is participating in the study but will not be informed directly as to which arm they will be enrolled in, however if they review the electronic chart record they will be able to identify which arm
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants will be randomly assigned to 1 of 2 arms, either control or pharmacist intervention

Study Record Dates

• First Submitted: June 20, 2022
• First Posted: July 5, 2022
• Study Start: July 4, 2022
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: April 21, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)