Optimising glycaemic control in paediatric patients on insulin pump therapy: impact of glycaemic load and bolus wave type on postprandial glycaemia

• Conditions: Type 1 Diabetes Mellitus; Metabolic and Endocrine - Diabetes

• Registration Number: ACTRN12605000762651
• Lead Sponsor: Royal Children's Hospital, Parkville, Vic 3052.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2005-11-24
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 36

Inclusion Criteria

Prepubertal children specifically targeted to eliminate potential confounding effects of counter-regulatory hormones of puberty.2. Type 1 diabetes > 1 year duration; active patients of RCH diabetes clinic3. Established use of insulin pump therapy (using short acting analog insulin) for > 3 months4. Insulin pump with incorporated meal bolus calculator device (capable of delivering both single and dual wave boluses)5. HbA1C < 8.6% HbA1C empirically chosen as cut-off for 'acceptable' baseline glycaemic control - corresponds to the mean HbA1C for all paediatric centres participating in the international Hvidore diabetes study group

Exclusion Criteria

1. Non-English speaking2. Diagnosed eating disorder3. Concomitant dietary restriction (eg food allergy)4. Use of any other medication that may lower blood glucose5. Free of diabetes-related complications (microvascular disease, hypothyroidism, coeliac disease).

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Postprandial normoglycaemia: Percent time spent with CGMS derived glucose reading between 4.0-10.0 mmol/l in the 3 hours post-prandial period[]

Secondary Outcome Measures

Name	Time	Method
Postprandial hyperglycaemia: Percent time spent with CGMS derived glucose reading >/=10.1 mmol/l in 3 hour post-prandial period.[];Postprandial hypoglycaemia: Percent time spent with CGMS </=3.9 mmol/l in 3 hour post-prandial period.[];Postprandial glycaemic variation: 30 minutely Continuous Overlapping Net Glycaemic Action (CONGA) in 3 hour post-prandial period.[]