non-insulin dependent diabetes mellitus type 2 diabetes
Conditions
Interventions
During the 6 week intervention period, all oral blood glucose lowering agents
will be discontinued, except patients' own dosage of metformin. Also, all
insulin up to 20 units daily will be discontin
Sponsors
Universitair Medisch Centrum Utrecht
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Elderly patients of 80 years or older Diagnosed with type 2 diabetes mellitus when they were 70 years or older Diagnosed with type 2 diabetes at least 12 months ago Receiving treatment with oral blood glucose lowering agents and/or insulin from their GP or nursing home physician
Exclusion criteria
Exclusion criteria: Single agent treatment of diabetes with metformin Treatment with more than 40 units of insulin per day HbA1c >9.0% at most recent check-up Renal clearance /= 200 mg/L (according to Dutch GP protocol Diabetes Mellitus type 2) Foot ulcer, currently or in medical history Proliferative retinopathy Recurrent urinary tract infections: 3 or more in the past 12 months Impossibility of treatment with metformin: contra-indications or hypersensitivity/intolerance Incapable of filling out questionnaires or noticing hyperglycemic complaints
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Drop-out rate based on hyperglycemic complaints and/or fasting blood glucose levels> 15 mmol/L: if more than 25% drop-out rate based on hyperglycemic complaints or fasting blood glucose > 15 mmol/L, then RCT wil be declared unfeasable. 2. Problems and positive experiences of patients and caretakers based on semistructured interviews 3. Average increase in fasting blood glucose level 6 weeks after discontinuation of all glucose lowering agents based on baseline-endpoint measurements | — |
Countries
Netherlands
Outcome results
None listed