Convenient diagnosis of gestational diabetes;Using Continuous Glucose Measurement as an alternative to the golden standard Oral Glucose Tolerance Test (OGTT).
Withdrawn
- Conditions
- diabetes diagnosed for the first time during pregnancyGestational diabetes10018424
- Registration Number
- NL-OMON51260
- Lead Sponsor
- Reinier de Graaf Groep
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Withdrawn
- Sex
- Not specified
- Target Recruitment
- 40
Inclusion Criteria
- The participant is pregnant
- The participant has a strong suspicion of gestational diabetes according to
the WHO-criteria for which an OGTT test must be performed.
- the participant is capable to understand the study procedures and is willing
and able to follow them.
Exclusion Criteria
- Use of substances that can affect glucose metabolism (such as
corticosteroids).
- Cardiovascular comorbidities or suspected cardiovascular comorbidities.
- Allergy of the skin, eczema or sensitivity to plasters.
- Patients with preexisting type 2 or 1 diabetes.
- BMI <18 of >40.
Study & Design
- Study Type
- Observational invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Glucose concentration in mmol/l measured by CGM and venous blood sampling,<br /><br>estimated food intake (time and type food), estimated activity level,<br /><br>demographics of the participants (age, sex, medication usage, lifestyle),<br /><br>scores of the perceived burden of the interventions (registrations, oGTT,<br /><br>venous sampling, CGM application and carrying). </p><br>
- Secondary Outcome Measures
Name Time Method <p>During the oGTT as part of standard care, an extra blood tube (3.5 ml in total)<br /><br>will be drawn to analyze the following laboratory parameters, such as insulin,<br /><br>c-peptide, lipid profile, NEFA, CRP, HbA1c. The above parameters can classify<br /><br>the specific diabetic phenotype.<br /><br><br /><br>Furthermore, there are indications that the parameter 1,5-anhydroglucitol can<br /><br>be of diagnostic value in the diagnosis of gestational diabetes.</p><br>