Contact information
Type
Scientific
Primary contact
Dr Jeffrey Johnson
ORCID ID
Contact details
#1200
10405 Jasper Avenue
Edmonton
T5J 3N4
Canada
jeff.johnson@ualberta.ca
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Acronym
STRIP-Type 2
Study hypothesis
The primary aim of STRIP-Type 2 is to determine the clinical impact of providing free Self-Monitoring of Blood Glucose (SMBG) supplies for people with type 2 diabetes. Secondary aims of STRIP-Type 2 are to determine the social and behavioural correlates of glycaemic control and the health behavioural impact of providing free SMBG supplies for people with type 2 diabetes.
Primary hypothesis:
Subjects with type 2 diabetes who receive free diabetes testing strips will have significantly improved HbA1c values as compared to a control group that was not supplied with the free strips.
Secondary hypotheses:
Those subjects who receive free diabetes testing strips will have significantly improved self-care activities as compared to a control group that was not supplied with the free strips, and those subjects who receive free diabetes testing strips will have a greater frequency of blood glucose tests as compared to the group that was not supplied with the free strips.
Ethics approval
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Quality of life
Patient information sheet
Condition
Type 2 diabetes
Intervention
We conducted a randomised controlled trial to evaluate the clinical and behavioural impact of simply providing free SMBG supplies to patients with type 2 diabetes, versus a common health care policy of patients paying out-of-pocket for their testing supplies.
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measures
Change in HbA1c over 6 months.
Secondary outcome measures
Our secondary outcome evaluated SMBG behaviours using the Summary of Diabetes Self-Care Activities (SDSCA). In addition, patients completed a self-administered survey at baseline and 6 month follow-up. The survey contained demographic and self-reported clinical information regarding duration of diabetes, comorbidities and complications due to diabetes, and diabetes education experience. Self-reported physical and mental health status was captured in the RAND-12.
Overall trial start date
01/01/2002
Overall trial end date
31/05/2003
Reason abandoned
Eligibility
Participant inclusion criteria
To be included in the study, patients must:
1. Have had type 2 diabetes of at least one year duration
2. Be 30 years of age or older
3. Not be on insulin
Patients that controlled their diabetes by diet alone were eligible if they met the above inclusion criteria.
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
300
Participant exclusion criteria
We excluded pregnant patients and those with gestational diabetes, as well as patients with private insurance coverage for SMBG supplies.
Recruitment start date
01/01/2002
Recruitment end date
31/05/2003
Locations
Countries of recruitment
Canada
Trial participating centre
#1200, 10405 Jasper Avenue
Edmonton
T5J 3N4
Canada
Sponsor information
Organisation
Institute of Health Economics (Canada)
Sponsor details
#1200
10405 Jasper Avenue
Edmonton
T5J 3N4
Canada
wdraginda@ihe.ca
Sponsor type
Research organisation
Website
Funders
Funder type
Industry
Funder name
Institute of Health Economics (Canada) (ref: 148)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Canadian Diabetes Association (Canada) (ref: 1249)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Aventis Canada (Canada) (ref: 243)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
Results in:
1. http://www.ncbi.nlm.nih.gov/sites/entrez?db=PubMed&cmd=Retrieve&list_uids=15238494
Publication citations
-
Bowker SL, Mitchell CG, Majumdar SR, Toth EL, Johnson JA, Lack of insurance coverage for testing supplies is associated with poorer glycemic control in patients with type 2 diabetes., CMAJ, 2004, 171, 1, 39-43.