Purpose of the clinical study: To evaluate the effectiveness, safety and usability of real time continuous glucose monitoring (rCGM) in neonatal intensive care (NICU)Primary objective:* To evaluate the effectiveness of rCGM in the regulation of…
ID
Source
Brief title
Condition
- Glucose metabolism disorders (incl diabetes mellitus)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Time percentage of sensor glucose (SG) within the target of 2.6-10 mmol/L
within the first six days of life of premature children
Secondary outcome
Efficacy
1) Mean sensor glucose (SG) in the first six days.
2) Time percentage of SG within the target of 4-8 mmol/L within the first six
days of life
3) SG variability in individuals as established by standard deviation in the
patient
4) Time percentage of glucose levels in hyperglycaemic region - SG > 15 mmol/L
Acceptability
1) Assessment score of the clinical staff on the impact on clinical care
2) Frequency of blood glucose monitoring
3) Clinical use of algorithm
Safety
1) Incidence of hypoglycaemia defined as an episode of blood glucose
>2.2 mmol/L and <2.6 mmol/L
2) Incidence of hypoglycaemia defined as a continuous episode of SG < 2.6
mmol/L for > 1 hour
3) Incidence of severe hypoglycaemia defined as an episode of BG *2.2 mmol/L
Economic aspects for health care
*
Cost efficiency expressed in terms of increasing costs per additional
case of adequate glucose control between 2.6 mmol/L - 10 mmol/L
Background summary
Increasing numbers of infants are being born preterm. These infants require
intensive care and have a high risk of early mortality and short term
morbidity. Surviving infants have a high incidence of long term health
problems, including learning difficulties with significant long term costs to
the NHS and society. Treatable neonatal causes of long term health problems
have been difficult to establish. National proirities for Research
have highlighted investigation of the management of babies born too early or
too small, and evaluation of the reasons for variations in outcome of "high
risk" neonates.
Early postnatal glucose control may be aan important modifiable risk factor for
clinical outcomes. In utero, glucose levels are normally maintained between 4-6
mmol/L, but infants born premature are at risk of both hyperlgycaemia (20-86%,
depending on how it is defined) and hypoglycaemia (<2.6 mmol/l, 17%).
Study objective
Purpose of the clinical study: To evaluate the effectiveness, safety and
usability of real time continuous glucose monitoring (rCGM) in neonatal
intensive care (NICU)
Primary objective:
* To evaluate the effectiveness of rCGM in the regulation of glucose levels in
premature children
* To evaluate the clinical acceptability in premature children
* To evaluate the safety in terms of risk of hypoglycaemia in premature children
Secondary objective:
* To evaluate the cost efficiency and the importance of such an intervention
for the national health service
Study design
Purpose of the clinical study:
To evaluate the effectiveness, safety and usability of real time continuous
glucose monitoring (rCGM) in neonatal intensive care (NICU)
Study design: Multicentre randomised controlled study
Baseline:
* Inclusion/exclusion
* Randomisation
* Demographics
* Clinical condition
Intervention period:
Cases
Day 1 * Day 6:
* Insertion of the glucose sensor
* Collection of glucose data by continuous real time glucose monitoring
* Glucose monitoring based on amended paper algorithm
* Further clinical particulars are recorded
* Day 3 - Clinical questionnaire
Controls:
Day 1 * Day 6:
* Insertion of the glucose sensor
* Collection of glucose data by continuous glucose monitoring not visible to
the medical team
* Glucose monitoring according to standard clinical practices
* Further clinical particulars are recorded
Follow-up period after the intervention: Day 7 to 36 weeks gestational age
Day 7:
Removal of the glucose sensor
Clinical questionnaire
Cases have a parent questionnaire
Day 14:
Checking the sensor site
Clinical particulars are recorded
Length, weight, head circumference
End of the study: 36 weeks corrected gestational age Clinical condition
Length, weight, head circumference Assessment of the use of means
Level of care (BAPM classification)
Study burden and risks
The baby may experience some discomfort when the sensor is inserted and there
is a small risk of mild bruising at the sensor site. The sensor does not cause
any discomfort once it has been inserted. There is a risk of infection, but
this has not occurred in the 400 cases in the privious studies. Similar sensors
have been used in more than 400 premature babies without any complications.
Hills Road Box 116 Level 8
Cambridge CB2OQQ
GB
Hills Road Box 116 Level 8
Cambridge CB2OQQ
GB
Listed location countries
Age
Inclusion criteria
* Informed consent of the parents
* * 33+6 weeks gestation
* * 24 hours of age
* Birth weight * 1200 g
Exclusion criteria
* A fatal congenital defect known at the time of enrolment in the study.
* All congenital metabolic disorders known at the time of enrolment in the study.
* Newborns who in the opinion of the treating doctor have no realistic prospect of survival at the time of enrolment in the study
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 |
|---|---|
| Other | 12793535 |
| CCMO | NL58499.029.16 |