diabetes mellitus type 2
Conditions
Interventions
The aim of this implementation study is to investigate if the use of skin auto-fluorescence, provided tot the treating physician, will change his treatment policy. This will be tested by randomising
Sponsors
University Medical Center Groningen
Eligibility
Inclusion criteria
Inclusion criteria: 1. Type 2 diabetes mellitus, based on usual WHO (2005) or ADA (2010) criteria; 2. Age 25-65 years; 3. Stratification for presence of known preexisting CV complications or not.
Exclusion criteria
Exclusion criteria: 1. Other conditions which may affect the interpretation of the UKPDS risk engine or skin autofluorescence measurements; 2. Persons from South Asian descent (UKPDS RE not valid in this group); 3. Diffuse skin disease especially on volar side lower arm (SAF measurement not valid); 4. Diseases threatening survival in short term; 5. Alcohol- or drug abuse; 6. (Recent, < 30 days) participation in another study; 7. No signed informed consent.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Differences in primary (one-year change in medication and in systolic blood pressure) will be compared between both arms. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Changes overall in HbA1c, LDL-cholesterol, skin autofluorescence (AGE reader), UKPDS risk score between baseline and one year; 2. Changes in UKPDS score and SAF from baseline to 1 year between the group in whom CV risk estimated with SAF and that estimated with the UKPDS risk engine is (higher or lower class) than that estimated with the UKPDS risk score, compared to the group in whom both rsisk estimated are concordant; 3. Differences between the concordant and discordant groups in target treatment values of blood pressure and lipids used by the treating physician. This will be assessed using a questionnaire. | — |
Contacts
Public ContactA.J. Smit
University Medical Center Groningen U3.129
Outcome results
None listed