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Consequences of reducing hypoglycemia-inducing glucose-lowering medication (medication that lowers glucose (sugar) levels in the blood and can cause low blood sugar) in people with type 2 diabetes of 70 years or older

Consequences of reducing hypoglycemia-inducing glucose-lowering medication in people with type two diabetes: an open cluster controlled intervention study comparing the implementation of a deprescribing program in primary care practises versus usual care

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN50008265
Enrollment
404
Registered
2023-03-09
Start date
2023-03-13
Completion date
Unknown
Last updated
2026-02-09

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

Conditions

Complications of type 2 diabetes Nutritional, Metabolic, Endocrine

Interventions

The intervention consists of an implementation program aimed at reducing glucose-lowering medications in people of 70 years of age that have too low Hba1c according to the 2018 guideline of the Dutch

Sponsors

Amsterdam University Medical Centers
Lead Sponsor

Eligibility

Sex/Gender
All
Age
70 Years to 100 Years

Inclusion criteria

Inclusion criteria: 1. Age 70 years or older 2. Having type 2 diabetes 3. Using insulin or sulfonyl urea derivative drugs 4. Recent Hba1c below 54 mmol/ mol or if deemed fragile by the GP practice below 58mmol/mol

Exclusion criteria

Exclusion criteria: Previously having indicated to be not willing to participate in studies using routine care electronic data

Design outcomes

Primary

MeasureTime frame
Two year follow up count of all ICPC coded reasons of encounter registered in the routine care electronical register of the GP practice that are potentially related to hypoglycemia selected in a Delphi procedure by three GP's.

Secondary

MeasureTime frame
1. Two year follow up count of all ICPC coded reasons of encounter selected in a Delphi procedure by three GP's registered in the routine care electronic register of the GP practice that are potentially related to hyperglycemia . 2. Two year follow up count of all ICPC coded reasons of encounter selected in a Delphi procedure by three GP's registered in the routine care electronic register of the GP practice that are potentially related to either hyperglycemia or hypoglycemia. 3. Quality of life, measured every six months using the EQ5D-5L and EQ5D-VAS as indicated by patients agreeing to fill in 6-monthly questionnaires. 4. Blood pressure measurements and laboratory measurements registered in the routine care electronic digital file of the GP: Hba1c, fasting plasma glucose measurements. 5. Number of medication prescriptions registered in the EMR 6. Hospital admissions, visits to emergency departments (hospital or primary care) and nursing home admissions as indicated by patients agreeing to fill in 6-monthly questionnaires. 7. Health care and patient cost including medical prescription data will be analyzed from the societal perspective based on 6 monthly patient questionnaires. 8. Cognitive evaluation using the Minicog questionnaire if deemed necessary by the health care professionals and registered in the medical file. 9. Process analysis: for the purpose of studying the implementation, we shall study an extraction of the EMR of the patients who were selected for DDP in the intervention study. As part of the analysis all free text in the GP file will be extracted and after erasing all potential identifying information, will be studied as well. Using the administrative labels regarding inclusion and participation in the DDP, we will be able to deduce the aspects that caused enrollment or exclusion in the DDP intervention and how it was performed and which medical interventions (medication changes, lab measurements) were done. We shall also organize interview

Countries

Netherlands

Contacts

Public ContactMarieke Blom
m.t.blom@amsterdamumc.nl+31 610305382

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 15, 2026