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An observational study investigating the effect of implementa-tion of the guidelines with Oral diabetes medication instead of insUlin therapy, in elderly with DIAbetes Mellitus

An observational study investigating the effect of implementa-tion of the guidelines with Oral diabetes medication instead of insUlin therapy, in elderly with DIAbetes Mellitus - Implementating the gUidelines in elderly DIAbetes Mellitus patients/OuDiam

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON57637
Enrollment
100
Registered
2025-01-03
Start date
2025-09-01
Completion date
Unknown
Last updated
2025-11-10

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

Conditions

diabetes type 2

Interventions

Sponsors

Amsterdam UMC
Lead Sponsor

Eligibility

Age
65 Years to 99 Years

Inclusion criteria

Inclusion criteria: • Age >=70 years • Type 2 diabetes with (very) high risk of CVD • Insulin use with or without SU • eGFR >10 ml/min • Willing to take oral insulin-sensitizing medication at the expense of insulin and SU. • Willing to wear a continuous glucose monitoring device • Able to understand informed consent • Access to and familiarity with internet use.

Exclusion criteria

Exclusion criteria: • Age <70 years • Type 2 diabetes without (very) high risk of CVD (Figure 2.) • eGFR <10 ml/min • Unwilling to take additional oral diabetes medication • Unwilling to wear a continuous glucose monitoring device • Evident cognitive impairments • Alcoholism, recreational drug use • Extreme cachexia (BMI <15 kg/m2) • Unable to use the internet and/or email. • Life expectancy of <2 yearsPrevious attempts to start a GLP1a or SGLT2i, which failed due to side effects 

Design outcomes

Primary

MeasureTime frame
Evaluating quality of life and patient satisfaction when implementing the guidelines by eliminating the need for injections and monitoring glucose levels of reducing or discontinuing insulin use and SU medication, at the expense of more oral diabetes medications, after six months and one year.

Secondary

MeasureTime frame
- Evaluating time in range according to continuous glucose monitoring in elderly diabetes patients before and after switching insulin with or without SU to the standard of care with oral insulin-sensitizing diabetes medication, after six months and one year. - Percentage of patients that will completely discontinue insulin and SU when started on medication according to the standard of care with insulin-sensitizing oral medication, while maintaining glycemic control, after six months and one year. - Percentage of patients achieving >=50% reduction of insulin when started on medication according to the standard of care with insulin-sensitizing oral medication, while maintaining glycemic control, after six months and one year. - Glycemic control, after achieving >=50% reduction of insulin when started on medication according to the standard of care with insulin-sensitizing oral medication, after six months and one year. - Evaluating the glycemic control when switching diabetes medication away from insulin and SU, towards more oral diabetes medications, after six months and one year. - Preservation of organ functions, such as renal, liver and cardiac function. - Evaluating general physicians satisfactory with the implementation of the update guideline.

Countries

Netherlands

Contacts

Public ContactSJ Pinto-Sietsma

Amsterdam UMC

s.j.pinto@amsterdamumc.nl020-5669111

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)