Evaluation of the usefulness of an electronic system to support decision making in the integral control of patients with type 2 diabetes mellitus treated in primary health care

Electronic clinical decision support system and multifactorial risk factor control in patients with type 2 diabetes in primary health care

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN11808779

Enrollment

159

Registered

2017-03-29

Start date

2015-02-01

Completion date

Unknown

Last updated

2017-12-18

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 Type 2 diabetes mellitus

Interventions

All participants attend a standard clinical visit in which their responsible physicians explain and propose the study. If they agree to take part, then blood pressure (BP) is measured and analysed and

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Aged 18 to 65 years 2. T2DM diagnosed at least one year before

Exclusion criteria

Exclusion criteria: 1. Over 65 years 2. Poor short-term prognosis according to clinical judgement (advanced comorbidities, frailty, and severe cognitive impairment)

Design outcomes

Primary

Measure	Time frame
Proportion of patients with T2DM with multi-factorial control of blood pressure, LDL cholesterol, and HbA1c is assessed through clinical examinations and blood testing at baseline and 12 weeks	—

Secondary

Measure	Time frame
1. Proportion of controlled patients for each individual factor (blood pressure, LDL cholesterol and HbA1c) is assessed through clinical examinations and blood testing at baseline and 12 weeks 2. Mean change in ystolic BP (SBP), diastolic BP (DBP), cLDL, and HbA1c is assessed through clinical examinations and blood testing at baseline and 12 weeks 3. Proportion of patients with potential adverse events attributable to intensification of treatment (glomerular filtration rate decrease >20%, CPK elevated 3 times the upper limit of normal [ULN], GPT elevated 3 times ULN, hypo- or hyperkalaemia, and hypoglycemia or hypotension episodes) is assessed through blood testing at 12 weeks and focused clinical interview (hypoglycaemia or hypotension episodes) 4. Primary care physicians’ satisfaction with the eCDSS is evaluated using an anonymous, semi-quantitative survey at the end of recruitment	—

Measure

Time frame

1. Proportion of controlled patients for each individual factor (blood pressure, LDL cholesterol and HbA1c) is assessed through clinical examinations and blood testing at baseline and 12 weeks 2. Mean change in ystolic BP (SBP), diastolic BP (DBP), cLDL, and HbA1c is assessed through clinical examinations and blood testing at baseline and 12 weeks 3. Proportion of patients with potential adverse events attributable to intensification of treatment (glomerular filtration rate decrease >20%, CPK elevated 3 times the upper limit of normal [ULN], GPT elevated 3 times ULN, hypo- or hyperkalaemia, and hypoglycemia or hypotension episodes) is assessed through blood testing at 12 weeks and focused clinical interview (hypoglycaemia or hypotension episodes) 4. Primary care physicians’ satisfaction with the eCDSS is evaluated using an anonymous, semi-quantitative survey at the end of recruitment

—

Countries

Spain

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026