|
ISRCTN
|
ISRCTN87372235
|
|
ClinicalTrials.gov identifier
|
|
|
Public title
|
Study of Testing Response in Patients with Type 2 Diabetes
|
|
Scientific title
|
|
|
Acronym
|
STRIP-Type 2
|
|
Serial number at source
|
N/A
|
|
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.
|
|
Lay summary
|
|
|
Ethics approval
|
Not provided at time of registration
|
|
Study design
|
Randomised controlled trial
|
|
Countries of recruitment
|
Canada
|
|
Disease/condition/study domain
|
Type 2 diabetes
|
|
Participants - 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.
|
|
Participants - exclusion criteria
|
We excluded pregnant patients and those with gestational diabetes, as well as patients with private insurance coverage for SMBG supplies.
|
|
Anticipated start date
|
01/01/2002
|
|
Anticipated end date
|
31/05/2003
|
|
Status of trial
|
Completed |
|
Patient information material
|
|
|
Target number of participants
|
300
|
|
Interventions
|
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.
|
|
Primary outcome measure(s)
|
Change in HbA1c over 6 months.
|
|
Secondary outcome measure(s)
|
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.
|
|
Sources of funding
|
1. Institute of Health Economics (Canada) (ref: 148)
2. Canadian Diabetes Association (Canada) (ref: 1249)
3. Aventis Canada (Canada) (ref: 243)
|
|
Trial website
|
|
|
Publications
|
Results in:
1. http://www.ncbi.nlm.nih.gov/sites/entrez?db=PubMed&cmd=Retrieve&list_uids=15238494
|
|
Contact name
|
Dr
Jeffrey
Johnson
|
|
Address
|
#1200, 10405 Jasper Avenue
|
|
City/town
|
Edmonton
|
|
Zip/Postcode
|
T5J 3N4
|
|
Country
|
Canada
|
|
Email
|
jeff.johnson@ualberta.ca
|
|
Sponsor
|
Institute of Health Economics (Canada)
|
|
Address
|
#1200, 10405 Jasper Avenue
|
|
City/town
|
Edmonton
|
|
Zip/Postcode
|
T5J 3N4
|
|
Country
|
Canada
|
|
Email
|
wdraginda@ihe.ca
|
|
Date applied
|
08/09/2005
|
|
Last edited
|
24/08/2007
|
|
Date ISRCTN assigned
|
06/10/2005
|
