Continuous glucose monitoring versus self-monitoring of blood glucose in women with gestational diabetes mellitus
Completed
- Conditions
- diabetes in pregnancyGestational diabetes1001265310026908
- Registration Number
- NL-OMON42812
- Lead Sponsor
- Maasstadziekenhuis
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 31
Inclusion Criteria
Women who are >=18 years old, diagnosed with GDM, < 36 weeks of gestation, are able to communicate and read in Dutch.
Exclusion Criteria
no singleton pregnancy judged by ultrasonography, diagnosis of diabetes mellitus before the current pregnancy.
Study & Design
- Study Type
- Observational invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Primary objective: To assess the hyperglycemic episodes (fasting glucose >= 5.3<br /><br>mmol/L and 6.7 mmol/l the rest of the day) detected by the CGMS when the SMBG<br /><br>is normal in a 24 hour period. </p><br>
- Secondary Outcome Measures
Name Time Method <p>1. The secondary endpoint is mean total time of hyperglycemia (glucose>= 5.3<br /><br>mmol/L fasting and >= 6.7 mmol/L) defined in minutes/day, that is detected by<br /><br>the CGMS compared to standard SMBG (7 measurements in a day).<br /><br><br /><br>2. Is there a difference in glycaemic control (data is binary: hyperglycaemia<br /><br>or no hyperglycaemia) between day 2 (SMBG) and day 3 (no SMBG) of the<br /><br>monitoring period?<br /><br><br /><br>Background (2): We are curious what the effect of SMBG is on the glucose<br /><br>regulation. Is it so that on the day of the SMBG, women adhere better to the<br /><br>diet and on the other days less or not? Possibly suggesting that hyperglycaemia<br /><br>could prevail unnoticed. </p><br>