Continuous glucose monitoring versus self-monitoring of blood glucose in women with gestational diabetes mellitus

Continuous glucose monitoring versus self-monitoring of blood glucose in women with gestational diabetes mellitus - The SensoCap Trial

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON42812

Enrollment

Registered

2015-12-08

Start date

2016-03-07

Completion date

Unknown

Last updated

2024-04-23

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

Conditions

diabetes in pregnancy Gestational diabetes

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Women who are >=18 years old, diagnosed with GDM,

Exclusion criteria

Exclusion criteria: no singleton pregnancy judged by ultrasonography, diagnosis of diabetes mellitus before the current pregnancy.

Design outcomes

Primary

Measure	Time frame
Primary objective: To assess the hyperglycemic episodes (fasting glucose >= 5.3 mmol/L and 6.7 mmol/l the rest of the day) detected by the CGMS when the SMBG is normal in a 24 hour period.	—

Secondary

Measure	Time frame
1. The secondary endpoint is mean total time of hyperglycemia (glucose>= 5.3 mmol/L fasting and >= 6.7 mmol/L) defined in minutes/day, that is detected by the CGMS compared to standard SMBG (7 measurements in a day). 2. Is there a difference in glycaemic control (data is binary: hyperglycaemia or no hyperglycaemia) between day 2 (SMBG) and day 3 (no SMBG) of the monitoring period? Background (2): We are curious what the effect of SMBG is on the glucose regulation. Is it so that on the day of the SMBG, women adhere better to the diet and on the other days less or not? Possibly suggesting that hyperglycaemia could prevail unnoticed.	—

Measure

Time frame

1. The secondary endpoint is mean total time of hyperglycemia (glucose>= 5.3 mmol/L fasting and >= 6.7 mmol/L) defined in minutes/day, that is detected by the CGMS compared to standard SMBG (7 measurements in a day). 2. Is there a difference in glycaemic control (data is binary: hyperglycaemia or no hyperglycaemia) between day 2 (SMBG) and day 3 (no SMBG) of the monitoring period? Background (2): We are curious what the effect of SMBG is on the glucose regulation. Is it so that on the day of the SMBG, women adhere better to the diet and on the other days less or not? Possibly suggesting that hyperglycaemia could prevail unnoticed.

—

Countries

Netherlands

Outcome results