MedPath

Diabetyping & lifestyle as a medicine

Recruiting
Conditions
Type 2 diabetes
Registration Number
NL-OMON29401
Lead Sponsor
TNO
Brief Summary

not applicable

Detailed Description

Not available

Recruitment & Eligibility

Status
Recruiting
Sex
Not specified
Target Recruitment
16
Inclusion Criteria

Patient is newly diagnosed with T2D
-Patient is about to start Metformin
-Patient is about to start with a second oral drug (like SU-derivates)
-Patient is about to start with an injectable drug (Insulin or GLP-1)

Besides that, the patients should meet the following inclusion criteria:
-Aged between 30-80 years
-Have a BMI between 25-35 kg/m-2
-Willing and able to sign the informed consent form
-Able to fill in the 360-degree questionnaire which is in Dutch
-Able to work with computers (e.g. for filling out questionnaires).

Exclusion Criteria

-Dialysis patients
-Possible limiting personal circumstances (e.g. unemployed, illness in the family, dept restructuring)
-Patients under treatment of a psychiatrist
-Incapacitated patients
-Patients in a palliative phase

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
The primary outcomes of this study are process variables related to the organizational and financial feasibility of implementation within primary care: time of primary caregivers, costs of medication and facilities and benefits for patients by lower health care use on the longer term.
Secondary Outcome Measures
NameTimeMethod
The secondary outcomes are related to (change in) health status of participants. First, changes in diabetes related markers such as HbA1c, glucose and insulin will be evaluated descriptively. Several indices can be derived from an OGGT and can indicate organ-specific effects of a distorted glucose tolerance. With these indices several subtypes of diabetes can be distinguished.
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