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"Convenient diagnosis of gestational diabetes";Using Continuous Glucose Measurement as an alternative to the golden standard Oral Glucose Tolerance Test (OGTT).

"Convenient diagnosis of gestational diabetes";Using Continuous Glucose Measurement as an alternative to the golden standard Oral Glucose Tolerance Test (OGTT). - Convenient diagnosis of gestational diabetes

Status
Unknown
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON51260
Enrollment
40
Registered
2021-12-02
Start date
Unknown
Completion date
Unknown
Last updated
2024-04-15

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

Conditions

diabetes diagnosed for the first time during pregnancy Gestational diabetes

Interventions

None listed

Sponsors

Reinier de Graaf Groep
Lead Sponsor

Eligibility

Inclusion criteria

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

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 40.

Design outcomes

Primary

MeasureTime frame
Glucose concentration in mmol/l measured by CGM and venous blood sampling, estimated food intake (time and type food), estimated activity level, demographics of the participants (age, sex, medication usage, lifestyle), scores of the perceived burden of the interventions (registrations, oGTT, venous sampling, CGM application and carrying).

Secondary

MeasureTime frame
During the oGTT as part of standard care, an extra blood tube (3.5 ml in total) will be drawn to analyze the following laboratory parameters, such as insulin, c-peptide, lipid profile, NEFA, CRP, HbA1c. The above parameters can classify the specific diabetic phenotype. Furthermore, there are indications that the parameter 1,5-anhydroglucitol can be of diagnostic value in the diagnosis of gestational diabetes.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)