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Randomized Controlled Trial
. 2017 Mar 6;7(3):e012982.
doi: 10.1136/bmjopen-2016-012982.

Computer-determined dosage of insulin in the management of neonatal hyperglycaemia (HINT2): protocol of a randomised controlled trial

Jane Alsweiler  1 , Kathryn Williamson  1 , Frank Bloomfield  2 , Geoffrey Chase  3 , Jane Harding  2
Affiliations
Randomized Controlled Trial

Computer-determined dosage of insulin in the management of neonatal hyperglycaemia (HINT2): protocol of a randomised controlled trial

Jane Alsweiler et al. BMJ Open. .

Abstract

Introduction: Neonatal hyperglycaemia is frequently treated with insulin, which may increase the risk of hypoglycaemia. Computer-determined dosage of insulin (CDD) with the STAR-GRYPHON program uses a computer model to predict an effective dose of insulin to treat hyperglycaemia while minimising the risk of hypoglycaemia. However, CDD models can require more frequent blood glucose testing than common clinical protocols. The aim of this trial is to determine if CDD using STAR-GRYPHON reduces hypoglycaemia in hyperglycaemic preterm babies treated with insulin independent of the frequency of blood glucose testing.

Methods and analysis: Design: Multicentre, non-blinded, randomised controlled trial.

Setting: Neonatal intensive care units in New Zealand and Australia.

Participants: 138 preterm babies ≤30 weeks' gestation or ≤1500 g at birth who develop hyperglycaemia (two consecutive blood glucose concentrations ≥10 mmol/L, at least 4 hours apart) will be randomised to one of three groups: (1) CDD using the STAR-GRYPHON model-based decision support system: insulin dose and frequency of blood glucose testing advised by STAR-GRYPHON, with a maximum testing interval of 4 hours; (2) bedside titration: insulin dose determined by medical staff, maximum blood glucose testing interval of 4 hours; (3) standard care: insulin dose and frequency of blood glucose testing determined by medical staff. The target range for blood glucose concentrations is 5-8 mmol/L in all groups. A subset of babies will have masked continuous glucose monitoring.

Primary outcome: is the number of babies with one or more episodes of hypoglycaemia (blood glucose concentration <2.6 mmol/L), during treatment with insulin.

Ethics and dissemination: This protocol has been approved by New Zealand's Health and Disability Ethics Committee: 14/STH/26. A data safety monitoring committee has been appointed to oversee the trial. Findings will be disseminated to participants and carers, peer-reviewed journals, guideline developers and the public.

Trial registration number: 12614000492651.

Keywords: Biological model; Blood glucose; Clinical decision support system; Hypoglycaemia; Preterm Infant.

PubMed Disclaimer

Conflict of interest statement

Competing interests: GC is the founder and director of Tiro Medical and undertakes an unpaid advisory role on the board of Monarch Medical. He received a grant from Medtronic for devices only, outside the submitted work.

Figures

Figure 1
Figure 1
Flow chart of study pathway.
See this image and copyright information in PMC

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