STUDIIO-Diabetes Pilot: STUdy of Drug Insurance to Improve Outcomes of Diabetes
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age25-64
SponsorSunnybrook Health Sciences Centre
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
clinical diagnosis of type 2 diabetes record in family physician's electronic medical record
lack of medication insurance
Disqualifiers
None
Trial design
Design model
Parallel
Treatments tested in this trial
No-cost Medications
Other interventionPatients 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.
Treatment groups
144 Participants
are divided into 2 treatment groupsGroup A: No-cost MedicationsExperimental treatment 1 intervention
Group B: Usual careNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Lacking medication insurance
Proportion of type 2 diabetes patients aged 25 to 64 who self-report that they lack medication insurance
Time frame
During 2 month run-in periodSecondary outcomes
1
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
Time frame
During 2 month run-in period2
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
Time frame
During 2 month run-in period3
Recipient of no-cost medications
Proportion of patients in the intervention group who receive medications from the Trillium Health Partners outpatient pharmacy
Time frame
One year4
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
Time frame
One yearOther outcomes
1
All-cause mortality or cardiovascular complications
All-cause mortality, or hospitalization for myocardial infarction, acute coronary syndrome, coronary revascularization, stroke or heart failure.
Time frame
One year2
Other chronic diabetes complications
Amputation, retinal photocoagulation, vitrectomy, intravitreal injection, incident microalbuminuria, incident chronic kidney disease
Time frame
One year3
Acute diabetes complications
Emergency department visit or hospitalization for hypo or hyperglycemia
Time frame
One year4
A1c control
A1c level
Time frame
One yearLocations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Sunnybrook Health Sciences Centre
Lead sponsor
Canadian Institutes of Health Research (CIHR)
Collaborator
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: