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Diabetes Type 2NCT05442840

Evaluation of Pharmacist Intervention for Individuals With Uncontrolled Type 2 Diabetes

A study testing Behavioral and drugs already approved and available for diabetes management in people with Diabetes Type 2, run by University of Manitoba at 1 site in Canada.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Diabetes Type 2
What is being tested?
Behavioral and drugs already approved and available for diabetes management
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
1 siteCanada
Study dates
4 Jul 2022to Apr 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Canada1 site

  • Portage Clinic

    Portage la Prairie, Manitoba, R1N 3V5

Other trials in Canada

About this study

Official title: Evaluation of Pharmacist Intervention and Education in a Patient-Centered, Multidisciplinary Approach for Individuals With Uncontrolled Type 2 Diabetes

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.

Read the detailed description

Recruitment will begin in July 2022, potential participants can self-refer or another healthcare provider may discuss the study and provide contact information to the study team for all interested potential participants. These potential participants would then be screened for eligibility by the pharmacist or PharmD (Doctor of Pharmacy) Intern. The goal is to enroll 60 participants in the study. All participants must provide consent to participate and will be asked to complete a participant survey.

All participants who consented will then be randomized into a control group which will not receive pharmacist intervention during the study period, or the intervention group which will receive pharmacist/PharmD Intern led intervention which includes a medication review, optimizing medication treatment options and frequent follow up and diabetes education. The control group participants will be offered pharmacist intervention following the study period. All participants will be asked to complete a participant survey at the start and end of the study. All participants will also have standard care from their physicians and other healthcare team members as required which would be standard of practice. All participants would also be asked to repeat their blood work at the end of the study period.

Conditions
Diabetes Type 2
Being tested
Behavioral and drugs already approved and available for diabetes management
Medical subject headings
Diabetes Mellitus, Type 2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Behavioral and drugs already approved and available for diabetes managementCombination 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

Study groups in NCT05442840
Study groupRoleWhat they receive
Control ArmNo interventionThe 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 ArmActive comparatorThe 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
Receives: Combination Product: Behavioral and drugs already approved and available for diabetes management

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in Baseline Hemoglobin A1C (HbA1C) at 10 months

    Measure of blood glucose control at the lab

    Measured: baseline and through study completion at 10 months approximately

Secondary outcomes (4)

  1. Participant Survey

    Evaluating the patients knowledge of diabetes management, comfort with managing their own diabetes care, perception of the pharmacist's role

    Measured: baseline and through study completion at 10 months approximately

  2. Modifiable Risk Factors -Cholesterol Level

    evaluating changes in modifiable risk factors such as cholesterol levels reported in mmol/L

    Measured: baseline and through study completion at 10 months approximately

  3. Modifiable Risk Factor - Body Mass Index

    evaluating changes in modifiable risk factors such as weight and height which will be combined to report body mass index in kg/m^2

    Measured: baseline and through study completion at 10 months approximately

  4. Modifiable Risk Factor - Blood Pressure

    evaluating changes in modifiable risk factors such as blood pressure reported in mmHg

    Measured: baseline and through study completion at 10 months approximately

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Jul 2022
  2. Study start4 Jul 2022
  3. Primary completionApr 2027 (estimated)
  4. Study completionApr 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Model description
Participants will be randomly assigned to 1 of 2 arms, either control or pharmacist intervention
Masking
Single blind
Who is masked
Care provider
Enrolment
60 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05442840
Sponsor's protocol ID
HS25460 (B2022:031)
Status last verified
Sep 2026
First submitted
20 Jun 2022
Last updated
21 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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

  • 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.

    PubMed 23937988

  • 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

  • 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.

  • 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

  • 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.

    PubMed 31110593

  • 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.

    PubMed 29561461

  • 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.

    PubMed 34637104

  • 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

  • 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.

    PubMed 25170354

  • 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.

    PubMed 26903767

  • 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.

    PubMed 26359961

Questions about this trial

What is this clinical trial studying?

A study testing Behavioral and drugs already approved and available for diabetes management in people with Diabetes Type 2, run by University of Manitoba at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 21 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Baseline Hemoglobin A1C (HbA1C) at 10 months (time frame: baseline and through study completion at 10 months approximately). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05442840, which also lists 12 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2026.

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