HyperglycaemiaPhase 4NCT01419873
Study of a Model-based Approach to Blood Glucose Control in Very-low-birthweight Neonates
A Phase 4 study testing Actrapid Human Insulin in people with Hyperglycaemia, run by Christchurch Women's Hospital at 1 site in New Zealand.
Trial summary
Very low birthweight neonates commonly develop high blood sugar levels. There is an association between high blood sugar levels and poorer short term outcomes but it is not known whether the high sugar level itself actually causes the problems. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Hyperglycaemia
- What is being tested?
- Actrapid Human Insulin
- How many people
- 30 participants
- Where
- 1 siteNew Zealand
- Study dates
- Aug 2008to Jun 2011
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Birthweight <1500g
- Blood sugar >/= 10mmol/L
- Clinician decision to start an insulin infusion
Who cannot join
- Infants who were moribund and not expected to survive
Trial locations and contacts
1 site in 1 country.
New Zealand1 site
Christchurch Womens Hospital, Canterbury District Health Board
Christchurch
About this study
Official title: Pilot Study of a Model-based Approach to Blood Glucose Control in Very-low-birthweight Neonates
Very low birthweight neonates commonly develop high blood sugar levels. There is an association between high blood sugar levels and poorer short term outcomes but it is not known whether the high sugar level itself actually causes the problems.
There are a range of ways to manage high sugar levels but there are no consensus guidelines to follow. One option is to manage the high sugar levels with an infusion of insulin. Studies looking at insulin infusions have often used fixed protocols to guide the amount of insulin to be given and are often complicated by hypoglycaemia.
This study investigated whether using a model-based approach to individualise insulin administration to neonates with high sugar levels would provide a safe and effective management option for controlling blood sugar levels and avoid the complication of low blood sugar levels.
- Conditions
- Hyperglycaemia
- Being tested
- Actrapid Human Insulin
- Keywords
- Hyperglycaemia, Very low birthweight infants, Insulin
- Medical subject headings
- Hyperglycemia, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Actrapid Human InsulinDrug
Actrapid Insulin is a drug used in routine neonatal practice to treat hyperglycaemia. The intervention in this study was to base dosing on insulin by a computer based-model approach as opposed to sliding scales, fixed protocols or clinician intuition
What is being measured
The primary outcome is the main question the study is designed to answer.
Hypoglycaemia whilst receiving insulin
Hypoglycaemia whilst the patient is receiving insulin as per the model-based method will be documented. The patients may require insulin at any time in their admission to NICU from birth to a maximum of 5 months of age when they would no longer be admitted to NICU.
Measured: Length of hospital stay in NICU which will be from birth to 5 months of age
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2011 (estimated)
- Study startAug 2008
- Primary completionJun 2011
- Study completionJun 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HyperglycaemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Christchurch Women's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Adrienne Lynn, Christchurch Women's Hospital
- Investigators
- Adrienne M Lynn, FRACP, Principal investigator, Canterbury District Helath Board
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01419873
- Sponsor's protocol ID
- URA/08/06/039
- Status last verified
- Aug 2011
- First submitted
- 12 Aug 2011
- Last updated
- 29 Aug 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
Le Compte AJ, Lynn AM, Lin J, Pretty CG, Shaw GM, Chase JG. Pilot study of a model-based approach to blood glucose control in very-low-birthweight neonates. BMC Pediatr. 2012 Aug 7;12:117. doi: 10.1186/1471-2431-12-117.
PubMed 22871230
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study of a Model-based Approach to Blood Glucose Control in Very-low-birthweight Neonates
- ClinicalTrials.gov ID
- NCT01419873
- Acronym / sponsor ID
- URA/08/06/039
- Conditions
- Hyperglycaemia
- Keywords
- Hyperglycaemia, Very low birthweight infants, Insulin
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Christchurch Women's HospitalUniversity, hospital or other
- Study start
- Aug 2008
- Primary completion
- Jun 2011 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 18 Aug 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Very low birthweight neonates commonly develop high blood sugar levels. There is an association between high blood sugar levels and poorer short term outcomes but it is not known whether the high sugar level itself actually causes the problems.
There are a range of ways to manage high sugar levels but there are no consensus guidelines to follow. One option is to manage the high sugar levels with an infusion of insulin. Studies looking at insulin infusions have often used fixed protocols to guide the amount of insulin to be given and are often complicated by hypoglycaemia.
This study investigated whether using a model-based approach to individualise insulin administration to neonates with high sugar levels would provide a safe and effective management option for controlling blood sugar levels and avoid the complication of low blood sugar levels.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Birthweight <1500g
- Blood sugar >/= 10mmol/L
- Clinician decision to start an insulin infusion
Key exclusion criteria (1 listed)
- Infants who were moribund and not expected to survive
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Actrapid Human InsulinActrapid Insulin is a drug used in routine neonatal practice to treat hyperglycaemia. The intervention in this study was to base dosing on insulin by a computer based-model approach as opposed to sliding scales, fixed protocols or clinician intuition | Drug | – |
Primary outcome
Hypoglycaemia whilst receiving insulin
Time frame: Length of hospital stay in NICU which will be from birth to 5 months of age
Hypoglycaemia whilst the patient is receiving insulin as per the model-based method will be documented. The patients may require insulin at any time in their admission to NICU from birth to a maximum of 5 months of age when they would no longer be admitted to NICU.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2011.
- Derived from this study: PubMed 22871230Le Compte AJ, Lynn AM, Lin J, Pretty CG, Shaw GM, Chase JG. Pilot study of a model-based approach to blood glucose control in very-low-birthweight neonates. BMC Pediatr. 2012 Aug 7;12:117. doi: 10.1186/1471-2431-12-117.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Adrienne M Lynn, FRACP principal investigator
Canterbury District Helath Board
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Actrapid Human Insulin in people with Hyperglycaemia, run by Christchurch Women's Hospital at 1 site in New Zealand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Aug 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in New Zealand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hypoglycaemia whilst receiving insulin (time frame: Length of hospital stay in NICU which will be from birth to 5 months of age). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01419873, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Aug 2011.