Study of Testing Response in Patients with Type 2 Diabetes

ISRCTN ISRCTN87372235
DOI https://doi.org/10.1186/ISRCTN87372235
Secondary identifying numbers N/A
Submission date
08/09/2005
Registration date
06/10/2005
Last edited
08/11/2022
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Nutritional, Metabolic, Endocrine
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Jeffrey Johnson
Scientific

#1200, 10405 Jasper Avenue
Edmonton
T5J 3N4
Canada

Email jeff.johnson@ualberta.ca

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Home
Study typeQuality of life
Scientific titleStudy of Testing Response in Patients with Type 2 Diabetes
Study acronymSTRIP-Type 2
Study objectivesThe 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(s)Not provided at time of registration
Health condition(s) or problem(s) studiedType 2 diabetes
InterventionWe 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 typeOther
Primary outcome measureChange in HbA1c over 6 months.
Secondary outcome measuresOur 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 study start date01/01/2002
Completion date31/05/2003

Eligibility

Participant type(s)Patient
Age groupAdult
SexBoth
Target number of participants300
Total final enrolment262
Key inclusion criteriaTo 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.
Key exclusion criteriaWe excluded pregnant patients and those with gestational diabetes, as well as patients with private insurance coverage for SMBG supplies.
Date of first enrolment01/01/2002
Date of final enrolment31/05/2003

Locations

Countries of recruitment

  • Canada

Study participating centre

#1200, 10405 Jasper Avenue
Edmonton
T5J 3N4
Canada

Sponsor information

Institute of Health Economics (Canada)
Research organisation

#1200, 10405 Jasper Avenue
Edmonton
T5J 3N4
Canada

Email wdraginda@ihe.ca
ROR logo "ROR" https://ror.org/03e81x648

Funders

Funder type

Industry

Institute of Health Economics (Canada) (ref: 148)

No information available

Canadian Diabetes Association (Canada) (ref: 1249)

No information available

Aventis Canada (Canada) (ref: 243)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing planNot provided at time of registration

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Other publications Association between insurance coverage for testing supplies and glycemic control 06/07/2004 Yes No
Results article 01/11/2006 08/11/2022 Yes No

Editorial Notes

08/11/2022: The following changes have been made:
1. Publication reference added.
2. The final enrolment number has been added from the reference.