The hypothesis is that SMBG underestimates the number of hyperglycaemic episodes in women with gestational diabetes mellitus. The aim of this study is to evaluate if CGMS detects hyperglycaemia when the standard SMBG day curve is normal.
ID
Source
Brief title
Condition
- Diabetic complications
- Maternal complications of pregnancy
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
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 outcome
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.
Background summary
Gestational Diabetes Mellitus (GDM) is a frequent pregnancy complication and
associated with complications for mother and child. Current management consists
of dietary intervention and if necessary additional insulin therapy. Treatment
decisions regarding initiation of insulin treatment are based on
self-monitoring of blood glucose (SMBG). The optimal frequency of glucose
measurements remains to be elucidated. The problem with SMBG is that it gives
single measurements and no longitudinal glucose profile. Continuous Glucose
Monitoring (CGM) provides information regarding the fluctuations of glucose
during the day. In this study we aim to evaluate the detection rate of
hyperglycemia with a CGMS (continuous glucose monitoring system) compared to
standard SMBG.
Study objective
The hypothesis is that SMBG underestimates the number of hyperglycaemic
episodes in women with gestational diabetes mellitus.
The aim of this study is to evaluate if CGMS detects hyperglycaemia when the
standard SMBG day curve is normal.
Study design
It is a one-year prospective observational study. The setting is outpatient.
Pregnant women with GDM are eligible to participate. Subjects will be informed
about the study during their regular visit to the diabetology outpatient clinic
in het Maasstad Hospital.
Patients can enrol in the study at any time before 36 weeks of gestation. All
subjects participating in the study will receive the CGMS (Medtronic® Minimed,
Northridge, Ca, USA), regardless of their treatment for GDM (diet or insulin).
The CGMS will monitor at 20, 30 and 36 weeks of gestation, depending on the
term of pregnancy in which they enter the study. Each monitoring period
consists of 72-hours and requires two visits to our centre. Subjects will visit
our centre a minimum of two times and a maximum of 6 times, depending on the
term of pregnancy in which they enter the study. During each visit the CMG
system I-Pro® is either inserted into the subject or removed and instructions
are given.
Timetable of visits:
Gestational age (weeks)
Week 20 Visit 1 (day 1) Visit 2 (day 4)
Inserting CGMS Removing CGMS
Week 30 Visit 3 (day 1) Visit 4 (day 4)
Inserting CGMS Removing CGMS
Week 36 Visit 5 (day 1) Visit 6 (day 4)
Inserting CGMS Removing CGMS
Each visit is the start of a 72-hour consecutive CGM period. Subjects need to
keep a diary of their intake during the monitoring period. In total subjects
will wear the CGMS intermittently for the duration of 9 days (maximum) during
pregnancy.
Study burden and risks
Subjects visit our centre a minimum of two and a maximum of six times during
pregnancy. Each visit the CGMS will be inserted/removed from the subject.
During the 72-hour monitoring period, the subject is required to measure blood
glucose three times a day to calibrate the device (day 1 and 3). It is standard
care to do a 7 point glucose day curve once a week (day 2). In total a maximum
of 6 extra blood glucose measurements are required per three day (72 hour)
monitoring period. Subjects are also required to fill in a diary of their
dietary intake during the monitoring periods. Potential discomfort could be in
the form of a local reaction (pain or hematoma) or skin rash due to the CGMS.
Maasstadweg 21
Rotterdam 3079 DZ
NL
Maasstadweg 21
Rotterdam 3079 DZ
NL
Listed location countries
Age
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.
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL55203.101.15 |