A randomised controlled trial to determine the effect of blood glucose self-monitoring in people with type two diabetes

Conditions

Type two diabetes Nutritional, Metabolic, Endocrine Diabetes

Grace O’Carroll, Jennifer Valeska Elli Brown, Claire Carswell, Charlie Peck, Gregor Russell et al. (21 authors)

BMJ Open2025-03-01

10.1136/bmjopen-2024-090295

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.

Simon J, Gray A, Clarke P, Wade A, Neil A, Farmer A, Diabetes Glycaemic Education and Monitoring Trial Group.

2008-04-17128 citations

10.1136/bmj.39526.674873.be

Impact of self monitoring of blood glucose in the management of patients with non-insulin treated diabetes: open parallel group randomised trial.

Farmer A, Wade A, Goyder E, Yudkin P, French D, Craven A, Holman R, Kinmonth AL, Neil A.

2007-06-25254 citations

10.1136/bmj.39247.447431.be

Interventions

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

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Aged 25 or above 2. With type two diabetes

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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)	—

Measure

Time frame

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)

—

Countries

United Kingdom

Outcome results

None listed