Condition category
Nutritional, Metabolic, Endocrine
Date applied
08/09/2005
Date assigned
06/10/2005
Last edited
24/08/2007
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

  1. 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.

Additional files

Editorial Notes