A randomised controlled trial to determine the effect of blood glucose self-monitoring in people with type two diabetes
| ISRCTN | ISRCTN47464659 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN47464659 |
| Secondary identifying numbers | HTA 01/38/05 |
- Submission date
- 13/01/2004
- Registration date
- 13/01/2004
- Last edited
- 07/05/2009
- 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 Andrew Farmer
Scientific
Scientific
Institute of Health Sciences
Roosevelt Drive
Headington
Oxford
OX3 7LF
United Kingdom
| Phone | +44 (0)1865 226 768 |
|---|---|
| andrew.farmer@dphpc.ox.ac.uk |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | GP practice |
| Study type | Treatment |
| Scientific title | |
| Study acronym | DiGEM |
| Study objectives | Tight blood glucose control is recommended for many people with type two diabetes to delay and prevent the occurrence of complications. Glycaemic monitoring is required to attain this objective and current guidelines suggest that HbA1c levels below 7% should be achieved where possible. Although many people find that checking-blood glucose levels at home is a helpful way to undertake glycaemic monitoring, there is a need for more evidence to support its systematic use among people with type two diabetes. Previous trials have been small and have not incorporated a consistent approach to applying the results of tests to lifestyle. The aim of this open randomised controlled trial is to compare the use of blood glucose self monitoring to the standard practice of intermittent HbA1c checks in people managing their type two diabetes with diet or oral hypoglycaemic tablets. All patients will receive additional information about managing their diabetes. Patients randomised to blood glucose testing will be trained in the use of the blood glucose meters and given additional support to help them interpret the results in relation to the measures they are undertaking to improve HbA1c. The main outcome is HbA1c levels in the different groups, with additional measurement of other risk factors for cardiovascular disease, satisfaction with care, quality of life and costs of care. In addition to a direct comparison of the different groups, the study will inform routine clinical practice by an exploratory study of those people who might gain particular benefit from using different techniques to check glycaemic control and a series of in-depth interviews with study participants. |
| Ethics approval(s) | The study protocol was approved by the Oxfordshire B Research Ethics Committee. |
| Health condition(s) or problem(s) studied | Type two diabetes |
| Intervention | Please note that, as of 15 January 2008, the end date of this trial has been updated from 30 June 2005 to 31 March 2007. Interventions: 1. Control arm: three-monthly HbA1c measurement 2. Monitoring arm: use of blood glucose monitor and clinician interpretation of results 3. Intensive arm: use of blood glucose monitor, patient interpretation of results and application to lifestyle |
| Intervention type | Other |
| Primary outcome measure | The primary outcome measure is HbA1c, while additional outcome measures include blood pressure, cholesterol, self-reported smoking status, frequency of hypoglycaemia, symptom severity, changes in oral hypoglycaemic medication, addition of insulin to medication regimens and changes in Diabetes Treatment Satisfaction, Diabetes Self Care Activities and Well-being Questionnaire scales at one year. |
| Secondary outcome measures | 1. Change in systolic and diastolic blood pressure 2. Weight 3. Serum cholesterol and High Density Lipoprotein (HDL) 4. Self-reported smoking status 5. Dietary intake and physical activity (the Diabetes Self Care Activities Questionnaire) 6. Medication adherence (the Medication Adherence Rating Scale) 7. Scores in the Diabetes Treatment Satisfaction Questionnaire and the Well-being Questionnaire (12 item) |
| Overall study start date | 01/10/2002 |
| Completion date | 31/03/2007 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 48 general practices in Oxfordshire and South Yorkshire; 453 patients |
| Key inclusion criteria | 1. Aged 25 or above 2. With type two diabetes |
| Key exclusion criteria | 1. Use of blood glucose monitor twice a week or more often over the previous three months 2. Current use of insulin 3. Co-morbidity or limited life expectancy that would make intensive glycaemic control inappropriate 4. Last clinic HbA1c or HbA1c at the assessment visit less than 6.2% 5. Unable to follow trial procedures 6. Not independent for activities of daily living |
| Date of first enrolment | 01/10/2002 |
| Date of final enrolment | 31/03/2007 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Institute of Health Sciences
Oxford
OX3 7LF
United Kingdom
OX3 7LF
United Kingdom
Sponsor information
Department of Health (UK)
Government
Government
Quarry House
Quarry Hill
Leeds
LS2 7UE
United Kingdom
| Phone | +44 (0)23 8059 5586 |
|---|---|
| Sheila.Greener@doh.gsi.gov.uk | |
| Website | http://www.dh.gov.uk/en/index.htm |
"ROR" |
https://ror.org/03sbpja79 |
Funders
Funder type
Government
NIHR Health Technology Assessment Programme - HTA (UK)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | protocol | 16/06/2005 | Yes | No | |
| Results article | results | 21/07/2007 | Yes | No | |
| Other publications | economic evaluation | 24/05/2008 | Yes | No | |
| Other publications | HTA monograph: | 01/02/2009 | Yes | No |
