Study of Testing Response in Patients with Type 2 Diabetes
| ISRCTN | ISRCTN87372235 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN87372235 |
| Protocol serial number | N/A |
| Sponsor | Institute of Health Economics (Canada) |
| Funders | Institute of Health Economics (Canada) (ref: 148), Canadian Diabetes Association (Canada) (ref: 1249), Aventis Canada (Canada) (ref: 243) |
- 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
Scientific
#1200, 10405 Jasper Avenue
Edmonton
T5J 3N4
Canada
| jeff.johnson@ualberta.ca |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | Study of Testing Response in Patients with Type 2 Diabetes |
| Study acronym | STRIP-Type 2 |
| Study objectives | 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(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure(s) |
Change in HbA1c over 6 months. |
| Key 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. |
| Completion date | 31/05/2003 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | All |
| Target sample size at registration | 300 |
| Total final enrolment | 262 |
| Key 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. |
| Key exclusion criteria | We excluded pregnant patients and those with gestational diabetes, as well as patients with private insurance coverage for SMBG supplies. |
| Date of first enrolment | 01/01/2002 |
| Date of final enrolment | 31/05/2003 |
Locations
Countries of recruitment
- Canada
Study participating centre
#1200, 10405 Jasper Avenue
Edmonton
T5J 3N4
Canada
T5J 3N4
Canada
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan | Not provided at time of registration |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | 01/11/2006 | 08/11/2022 | Yes | No | |
| Other publications | Association between insurance coverage for testing supplies and glycemic control | 06/07/2004 | 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.
