Towards a more cost-effective diabetes control in primary care: the EFFIMODI (EFFIcient MOnitoring of DIabetes) trial

Six-monthly monitoring compared with three-monthly monitoring in type 2 diabetes mellitus: a randomised, controlled, patient-preference equivalence trial in primary care

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN93201802

Enrollment

2250

Registered

2009-07-14

Start date

2009-04-16

Completion date

Unknown

Last updated

2015-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 2 diabetes mellitus Nutritional, Metabolic, Endocrine Non-insulin-dependent diabetes mellitus

Interventions

Control: three-monthly diabetes monitoring by general practitioner and practice nurse Intervention: six-monthly diabetes monitoring by general practitioner and practice nurse The intervention will las

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. People with DM2 2. Aged 40 - 80 years, either sex 3. Treated by their general practitioner

Exclusion criteria

Exclusion criteria: Contraindications for less frequent than three-monthly monitoring: 1. Duration of DM2 for less than one year 2. Insulin treatment 3. HbA1c greater than 7.5% 4. Systolic blood pressure greater than 145 mmHg 5. Total cholesterol greater than 5.2 mmol/L

Design outcomes

Primary

Measure	Time frame
Current information as of 30/03/2010: Percentage of people that remains under good cardiometabolic control, defined as having HbA1c less than or equal to 7.5% and systolic blood pressure less than or equal to 145 mmHg and total cholesterol less than or equal to 5.2 mmol/l. HbA1c, systolic blood pressure and total cholesterol will be collected from the general practitioners' Information System. Initial information at time of registration: Change in glycaemic control, expressed as the mean change in HbA1c percentage between baseline and follow-up. HbA1c will be collected from the general practitioners' Information System.	—

Measure

Time frame

Current information as of 30/03/2010: Percentage of people that remains under good cardiometabolic control, defined as having HbA1c less than or equal to 7.5% and systolic blood pressure less than or equal to 145 mmHg and total cholesterol less than or equal to 5.2 mmol/l. HbA1c, systolic blood pressure and total cholesterol will be collected from the general practitioners' Information System. Initial information at time of registration: Change in glycaemic control, expressed as the mean change in HbA1c percentage between baseline and follow-up. HbA1c will be collected from the general practitioners' Information System.

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Secondary

Measure	Time frame
Differences in: 1. Blood pressure, collected from the general practitioners? Information System 2. Body mass index, collected from the general practitioners? Information System 3. Cholesterol, collected from the general practitioners? Information System 4. Fasting blood glucose, collected from the general practitioners? Information System 5. Lifestyle factors (smoking behaviour, physical activity), measured using the SQUASH questionnaire before and after the intervention period 6. Patients' quality of life, measured using the 36-item Short Form Health Survey (SF-36) and EuroQoL questionnaire (EQ5D) before and after the intervention period 7. Diabetes-specific distress, measured using the Problem Areas In Diabetes (PAID) questionnaire before and after the intervention period 8. Satisfaction with care, measured using the Diabetes Treatment Satisfaction Questionnaire (DTSQ) before and after the intervention period 9. Adherence with medications, collected from the general practitioners? Information System Added as of 30/03/2010: 10. HbA1c, collected from the general practitioners' Information System	—

Measure

Time frame

Differences in: 1. Blood pressure, collected from the general practitioners? Information System 2. Body mass index, collected from the general practitioners? Information System 3. Cholesterol, collected from the general practitioners? Information System 4. Fasting blood glucose, collected from the general practitioners? Information System 5. Lifestyle factors (smoking behaviour, physical activity), measured using the SQUASH questionnaire before and after the intervention period 6. Patients' quality of life, measured using the 36-item Short Form Health Survey (SF-36) and EuroQoL questionnaire (EQ5D) before and after the intervention period 7. Diabetes-specific distress, measured using the Problem Areas In Diabetes (PAID) questionnaire before and after the intervention period 8. Satisfaction with care, measured using the Diabetes Treatment Satisfaction Questionnaire (DTSQ) before and after the intervention period 9. Adherence with medications, collected from the general practitioners? Information System Added as of 30/03/2010: 10. HbA1c, collected from the general practitioners' Information System

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Countries

Netherlands

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Mar 23, 2026