Condition category
Nutritional, Metabolic, Endocrine
Date applied
13/01/2004
Date assigned
13/01/2004
Last edited
07/05/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

http://www.herc.ox.ac.uk/research/trials/digem.shtml

Contact information

Type

Scientific

Primary contact

Dr Andrew Farmer

ORCID ID

Contact details

Institute of Health Sciences
Roosevelt Drive
Headington
Oxford
OX3 7LF
United Kingdom
+44 (0)1865 226 768
andrew.farmer@dphpc.ox.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

HTA 01/38/05

Study information

Scientific title

Acronym

DiGEM

Study hypothesis

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

The study protocol was approved by the Oxfordshire B Research Ethics Committee.

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

GP practices

Trial type

Treatment

Patient information sheet

Condition

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

Phase

Not Specified

Drug names

Primary outcome measures

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 trial start date

01/10/2002

Overall trial end date

31/03/2007

Reason abandoned

Eligibility

Participant inclusion criteria

1. Aged 25 or above
2. With type two diabetes

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

48 general practices in Oxfordshire and South Yorkshire; 453 patients

Participant 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

Recruitment start date

01/10/2002

Recruitment end date

31/03/2007

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Institute of Health Sciences
Oxford
OX3 7LF
United Kingdom

Sponsor information

Organisation

Department of Health (UK)

Sponsor details

Quarry House
Quarry Hill
Leeds
LS2 7UE
United Kingdom
+44 (0)23 8059 5586
Sheila.Greener@doh.gsi.gov.uk

Sponsor type

Government

Website

http://www.dh.gov.uk/en/index.htm

Funders

Funder type

Government

Funder name

NIHR Health Technology Assessment Programme - HTA (UK)

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

1. 2009 HTA monograph: http://www.ncbi.nlm.nih.gov/pubmed/19254484
2. 2008 economic evaluation in http://www.ncbi.nlm.nih.gov/pubmed/18420663
3. 2007 results in http://www.ncbi.nlm.nih.gov/pubmed/17591623
4. 2005 protocol in http://www.ncbi.nlm.nih.gov/pubmed/15960852

Publication citations

  1. Protocol

    Farmer A, Wade A, French DP, Goyder E, Kinmonth AL, Neil A, The DiGEM trial protocol--a randomised controlled trial to determine the effect on glycaemic control of different strategies of blood glucose self-monitoring in people with type 2 diabetes [ISRCTN47464659]., BMC Fam Pract, 2005, 6, 25, doi: 10.1186/1471-2296-6-25.

  2. Farmer AJ, Wade AN, French DP, Simon J, Yudkin P, Gray A, Craven A, Goyder L, Holman RR, Mant D, Kinmonth AL, Neil HA, , Blood glucose self-monitoring in type 2 diabetes: a randomised controlled trial., Health Technol Assess, 2009, 13, 15, iii-iv, ix-xi, 1-50, doi: 10.3310/hta13150.

  3. Simon J, Gray A, Clarke P, Wade A, Neil A, Farmer A, , Cost effectiveness of self monitoring of blood glucose in patients with non-insulin treated type 2 diabetes: economic evaluation of data from the DiGEM trial., BMJ, 2008, 336, 7654, 1177-1180, doi: 10.1136/bmj.39526.674873.BE.

  4. Farmer A, Wade A, Goyder E, Yudkin P, French D, Craven A, Holman R, Kinmonth AL, Neil A, Impact of self monitoring of blood glucose in the management of patients with non-insulin treated diabetes: open parallel group randomised trial., BMJ, 2007, 335, 7611, 132, doi: 10.1136/bmj.39247.447431.BE.

Additional files

Editorial Notes