Type 2 Diabetes MellitusNCT03804905
STUDIIO-Diabetes Pilot: STUdy of Drug Insurance to Improve Outcomes of Diabetes
A study testing No-cost Medications in people with Type 2 Diabetes Mellitus and Medication Adherence, run by Sunnybrook Health Sciences Centre.
Trial summary
Canada is the only country with a universal health insurance system that does not provide coverage for prescription drugs to all residents. One-third of working-age Canadians have no insurance. Read more about this study
- Who is it for?
- Ages 25 to 64 years
- Conditions the study is for
- Type 2 Diabetes Mellitus, Medication Adherence, Medication Compliance
- What is being tested?
- No-cost Medications
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 144 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2026to 31 Dec 2026
- 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 25 to 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- clinical diagnosis of type 2 diabetes record in family physician's electronic medical record
- lack of medication insurance
Who cannot join
- -
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Pilot Pragmatic Randomized Controlled Trial to Evaluate the Impact of Improving Access to Drugs on Type 2 Diabetes Care, Outcomes and Costs
Canada is the only country with a universal health insurance system that does not provide coverage for prescription drugs to all residents. One-third of working-age Canadians have no insurance. Importantly, many of these uninsured patients already face other barriers to good health: low income, new immigrants, single mothers, etc. For these patients, taking prescription drugs - especially chronic disease treatments that may be required lifelong - can be difficult due to high costs. Patients skip doses, delay renewing prescriptions, or simply do not fill prescriptions recommended by their doctors, because they do not have insurance to cover the costs of prescriptions. Previous research by the study team has suggested that the lack of a universal drug insurance program for working-age Canadians affects the health and well-being of low-income people with diabetes. The goal of this research is to determine the clinical and economic impact of providing drug coverage for uninsured type 2 diabetics.
Read the detailed description
Previous research has found that lowering patients' out-of-pocket costs has a positive impact on health service utilization, risk factor control and patient-reported health for many chronic diseases, including diabetes, hypertension, HIV and asthma. Among patients with chronic disease, medication adherence was inversely associated with hospitalization rates and total healthcare costs, and these relationships were far stronger for diabetes than for any other chronic disease. A recent meta-analysis of eight observational studies showed that adherence with diabetes medications is associated reduction in cardiovascular events, all-cause mortality and all-cause hospitalization. However, virtually all of this previous research has been observational. Only one rigorous intervention study has examined the impact of reducing patient borne drug costs on clinical outcomes. The outcome of this study showed that free medications led to health outcome improvements and a trend towards lower costs.
The goal of this research project is to determine the impact of providing drug coverage to uninsured individuals with one of the most costly chronic diseases, type 2 diabetes. The ultimate goal is to evaluate if lowering out-of-pocket drug costs for uninsured patients is effective and cost-effective to reduce disease morbidity and mortality. Will policy intervention to reduce patients' drug costs would actually translate into improvements in their health outcomes? What impact a universal program would have on overall drug utilization? What total budget impact such a program might have? What extent the cost savings accrued from improving health outcomes might offset the program's implementation costs. Answering these questions will provide essential evidence to inform decision making for a national publicly-funded pharmacare program.
It will demonstrate how medication utilization changes when access improves, and will identify if barriers to utilization other than affordability exist. Crucially, the economic analyses will help policy makers understand the budget impact and cost-effectiveness of a pharmacare intervention. Thus, this research will provide vital information for policy makers crafting a program to provide free drugs to all uninsured Canadians with chronic disease. Such a program is anticipated to have a positive impact on patient experience: to improve health equity and access for vulnerable patients; to facilitate greater medication adherence; and to enhance shared decision-making between patients and their clinicians for effective self-management care paths. The ultimate impact of this research will be evidence for the cost effectiveness or even cost savings of a drug insurance program aimed at the improving access to medications for disadvantaged patients who are currently uninsured.
- Conditions
- Type 2 Diabetes Mellitus, Medication Adherence, Medication Compliance, Medication Nonadherence
- Being tested
- No-cost Medications
- Keywords
- Type 2 Diabetes Mellitus, Medication Compliance, Medication Insurance
- Medical subject headings
- Diabetes Mellitus, Type 2, Medication Adherence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No-cost MedicationsOther
Patients will be connected to Trillium Health Partners outpatient pharmacy, and they will be given an information sheet with further details. The patients will get free access to diabetes, blood pressure and cholesterol medications and for glucose test strips. They can attend the pharmacy in person or arrange for home delivery.
| Study group | Role | What they receive |
|---|---|---|
| No-cost Medications | Experimental | Eligible patients of physicians allocated to the no-cost medications arm will receive free medications through Trillium Health Partners outpatient pharmacy. Receives: Other: No-cost Medications |
| Usual care | No intervention | Eligible patients of physicians allocated to the usual care arm will continue to access their medications through self-pay or other mechanisms. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lacking medication insurance
Proportion of type 2 diabetes patients aged 25 to 64 who self-report that they lack medication insurance
Measured: During 2 month run-in period
Secondary outcomes (4)
Online questionnaire during the run-in period
Proportion of type 2 diabetes patients aged 25 to 64 who complete the secure online questionnaire during the run-in period
Measured: During 2 month run-in period
Response to the insurance status question
Proportion of type 2 diabetes patients aged 25 to 64 who responded to the insurance status question on the online questionnaire
Measured: During 2 month run-in period
Recipient of no-cost medications
Proportion of patients in the intervention group who receive medications from the Trillium Health Partners outpatient pharmacy
Measured: One year
Time from allocation to use of Trillium Health Partners outpatient pharmacy
Time from allocation to the intervention group to use of the Trillium Health Partners outpatient pharmacy
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2019
- Study start1 Jan 2026 (estimated)
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by Sunnybrook Health Sciences CentreThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 144 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sunnybrook Health Sciences Centre
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03804905
- Sponsor's protocol ID
- 103-2018
- Status last verified
- Dec 2024
- First submitted
- 19 Dec 2018
- Last updated
- 24 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Pragmatic Randomized Controlled Trial to Evaluate the Impact of Improving Access to Drugs on Type 2 Diabetes Care, Outcomes and Costs
- ClinicalTrials.gov ID
- NCT03804905
- Acronym / sponsor ID
- 103-2018
- Conditions
- Type 2 Diabetes Mellitus, Medication Adherence, Medication Compliance, Medication Nonadherence
- Keywords
- Type 2 Diabetes Mellitus, Medication Compliance, Medication Insurance
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 144 participants (estimated)
- Lead sponsor
- Sunnybrook Health Sciences CentreUniversity, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Study start
- 1 Jan 2026 (estimated)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 15 Jan 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Canada is the only country with a universal health insurance system that does not provide coverage for prescription drugs to all residents. One-third of working-age Canadians have no insurance. Importantly, many of these uninsured patients already face other barriers to good health: low income, new immigrants, single mothers, etc. For these patients, taking prescription drugs - especially chronic disease treatments that may be required lifelong - can be difficult due to high costs. Patients skip doses, delay renewing prescriptions, or simply do not fill prescriptions recommended by their doctors, because they do not have insurance to cover the costs of prescriptions. Previous research by the study team has suggested that the lack of a universal drug insurance program for working-age Canadians affects the health and well-being of low-income people with diabetes. The goal of this research is to determine the clinical and economic impact of providing drug coverage for uninsured type 2 diabetics.
Detailed description
Previous research has found that lowering patients' out-of-pocket costs has a positive impact on health service utilization, risk factor control and patient-reported health for many chronic diseases, including diabetes, hypertension, HIV and asthma. Among patients with chronic disease, medication adherence was inversely associated with hospitalization rates and total healthcare costs, and these relationships were far stronger for diabetes than for any other chronic disease. A recent meta-analysis of eight observational studies showed that adherence with diabetes medications is associated reduction in cardiovascular events, all-cause mortality and all-cause hospitalization. However, virtually all of this previous research has been observational. Only one rigorous intervention study has examined the impact of reducing patient borne drug costs on clinical outcomes. The outcome of this study showed that free medications led to health outcome improvements and a trend towards lower costs.
The goal of this research project is to determine the impact of providing drug coverage to uninsured individuals with one of the most costly chronic diseases, type 2 diabetes. The ultimate goal is to evaluate if lowering out-of-pocket drug costs for uninsured patients is effective and cost-effective to reduce disease morbidity and mortality. Will policy intervention to reduce patients' drug costs would actually translate into improvements in their health outcomes? What impact a universal program would have on overall drug utilization? What total budget impact such a program might have? What extent the cost savings accrued from improving health outcomes might offset the program's implementation costs. Answering these questions will provide essential evidence to inform decision making for a national publicly-funded pharmacare program.
It will demonstrate how medication utilization changes when access improves, and will identify if barriers to utilization other than affordability exist. Crucially, the economic analyses will help policy makers understand the budget impact and cost-effectiveness of a pharmacare intervention. Thus, this research will provide vital information for policy makers crafting a program to provide free drugs to all uninsured Canadians with chronic disease. Such a program is anticipated to have a positive impact on patient experience: to improve health equity and access for vulnerable patients; to facilitate greater medication adherence; and to enhance shared decision-making between patients and their clinicians for effective self-management care paths. The ultimate impact of this research will be evidence for the cost effectiveness or even cost savings of a drug insurance program aimed at the improving access to medications for disadvantaged patients who are currently uninsured.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| No-cost Medications | Experimental | Other: No-cost MedicationsEligible patients of physicians allocated to the no-cost medications arm will receive free medications through Trillium Health Partners outpatient pharmacy. |
| Usual care | No intervention | –Eligible patients of physicians allocated to the usual care arm will continue to access their medications through self-pay or other mechanisms. |
Who may qualify
- Ages
- 25 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- clinical diagnosis of type 2 diabetes record in family physician's electronic medical record
- lack of medication insurance
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No-cost MedicationsPatients will be connected to Trillium Health Partners outpatient pharmacy, and they will be given an information sheet with further details. The patients will get free access to diabetes, blood pressure and cholesterol medications and for glucose test strips. They can attend the pharmacy in person or arrange for home delivery. | Other | No-cost Medications |
Primary outcome
Lacking medication insurance
Time frame: During 2 month run-in period
Proportion of type 2 diabetes patients aged 25 to 64 who self-report that they lack medication insurance
4 secondary outcomes
Online questionnaire during the run-in period
Time frame: During 2 month run-in period
Response to the insurance status question
Time frame: During 2 month run-in period
Recipient of no-cost medications
Time frame: One year
Time from allocation to use of Trillium Health Partners outpatient pharmacy
Time frame: One year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Dec 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing No-cost Medications in people with Type 2 Diabetes Mellitus and Medication Adherence, run by Sunnybrook Health Sciences Centre.
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 2 inclusion and 1 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: opening soon, as of the sponsor's last update on 24 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
Contact Baiju Shah, MD PhD FRCPC (416-997-4706, baiju.shah@ices.on.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lacking medication insurance (time frame: During 2 month run-in period). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 24 Dec 2024.