Investigate the CGMS results in comparison with an OGTT and one-day self monitoring of blood glucose. Thereby compare the glucose patterns of patients with an impaired glucose tolerance to patient with a normal glucose tolerance and CFRD.
ID
Source
Brief title
Condition
- Respiratory disorders congenital
- Glucose metabolism disorders (incl diabetes mellitus)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Glucose values during a three-day period extracted by the CGMS and the blood
glucose levels of a one-day blood glucose self-monitoring.
Secondary outcome
Not applicable
Background summary
The most common complication in Cystic Fibrosis (CF) is Cystic Fibrosis-Related
Diabetes (CFRD). An oral glucose tolerance test (OGTT) is recommended for
diagnosing CFRD. The continuous glucose monitoring system (CGMS) is a
relatively new instrument to measure subcutaneous glucose levels. This may give
additional information in the diagnosis and understanding of CFRD.
Study objective
Investigate the CGMS results in comparison with an OGTT and one-day self
monitoring of blood glucose. Thereby compare the glucose patterns of patients
with an impaired glucose tolerance to patient with a normal glucose tolerance
and CFRD.
Study design
Prospective clinical comparing study
Study burden and risks
The total scope of the study comprises maximum four days. On the first day
patienets are admitted into the hospital for 2 hours. At this visit, they will
undergo physical examination by determination of body temperature, blood
pressure and pulses and will be questioned about their present clinical status.
A glucose sensor is placed subcutaneously on the abdomen. After one hour, the
sensor will be calibrated. Each day four random blood glucose levels have to be
charged in the sensor to calibrate itThe sensor remains for three days. On day
two, patients are asked to do a one-day blood glucose self-monitoring with 7
monitoring moments, i.e. fasting, before en one hour after each meal, and
before bedtime. After the three-day period patients can remove the sensor by
themselves and return it within a few days to the hospital. The sensor will be
read out retrospectively.
Leyweg 275
2545 CH Den Haag
Nederland
Leyweg 275
2545 CH Den Haag
Nederland
Listed location countries
Age
Inclusion criteria
1. Cystic fibrosis
2. > 18 years
Exclusion criteria
1. Exocrine pancreas sufficiency
2. Former Cystic fibrosis-related diabetes diagnosis
3. Organ transplants
4. Pregnancy
5. Use of medication interfering with glucose tolerance
6. Recent pulmonary exacerbation, requiring antibiotic therapy within past 4 weeks
7. Too short follow-up period of CGMS (< 24 hours)
Design
Recruitment
metc-ldd@lumc.nl
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Other (possibly less up-to-date) registrations in this register
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In other registers
Register | ID |
---|---|
CCMO | NL21343.098.08 |