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Trial registered on ANZCTR


Registration number
ACTRN12605000762651
Ethics application status
Approved
Date submitted
22/11/2005
Date registered
24/11/2005
Date last updated
24/11/2005
Type of registration
Prospectively registered

Titles & IDs
Public title
Optimising glycaemic control in paediatric patients on insulin pump therapy: impact of glycaemic load and bolus wave type on postprandial glycaemia
Scientific title
Optimising glycaemic control in paediatric patients on insulin pump therapy: impact of glycaemic load and bolus wave type on postprandial glycaemia
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Type 1 Diabetes Mellitus 918 0
Condition category
Condition code
Metabolic and Endocrine 985 985 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Study design:
Open, cross-over trial comparing the effects on Continuous Glucose Monitoring System (CGMS) measured post prandial glycaemia of different insulin bolus types administered with meals of different (high vs low) GI and GL content. Each participant will serve as his/her own control.
All interventions and observations involved in the study will take place in a controlled environment in the Australian Paediatric Pharmacological Research Unit (APPRU) at RCH. The study will involve attendance for 6.5hrs/ day on 5 days in total (to be divided into blocks of 2 or 3 sequential days in 2 different weeks).
A standardized format will be followed for every patient on each day. Each day will start with a standardized 'glycaemic wash-out' breakfast that aims to ensure that each subject commences the study period with a blood glucose level between 4-8mmol/l. Thereafter participants will receive one study meal with a predetermined premeal insulin bolus per day and their glycaemic response over the following 3 hours will be monitored using CGMS.
Meal characteristics:
The study will involve 2 different meals, meal A & meal B.
Both meals will contain identical macronutrient content (i.e. amount (grams) of carbohydrate, protein and fat will be equal in both).
The only nutritional difference between the 2 meals will be their GI (and therefore their GL - a function of GI and carbohydrate amount) content.
Meal A = Low GI / Low GL.
Meal B = High GI/ High GL

Overview of insulin bolus / meal type combinations:

Days 1 and 2 will both involve Meal A.

The order in which subjects administer the different bolus types will be randomly assigned:
Either Day 1: Meal A + standard 'single wave' bolus, followed by
Day 2: Meal A + 'dual wave' bolus
OR Day 1: Meal A + 'dual wave' bolus, followed by
Day 2: Meal A + standard 'single wave' bolus

Single wave bolus: The dose of the standard 'single wave' bolus will be calculated based on the subject's pre-prandial capillary blood glucose by the dose calculator incorporated into each subject's pump device (contains preprogrammed information on that subject's insulin sensitivity and insulin: carbohydrate ratio).

Dual wave bolus: As Meal A is of low GI/GL content, the standard pre-assigned dual wave ratio will consist of a 20:80 split (20% of dose given as immediate 'single wave' over ~3mins; 80% then given as 'extended wave' over 2hrs). The actual dose of each subject's insulin bolus will be calculated by the dose calculator incorporated into their own pump as outlined above.

Days 3 and 4 will involve Meal B with randomisation to premeal insulin wave type as above. As Meal B is high GI/GL, a 40:60% split in the dual wave components will be used.

Day 5 will involve Meal A and individualized insulin dosing schedules based on physician analysis of the CGMS data obtained from days 1 & 2. A dual wave bolus will be administered, the split ratio of which will be determined by the postprandial glycaemia observed on days 1 & 2.
Intervention code [1] 771 0
None
Comparator / control treatment
Control group
Dose comparison

Outcomes
Primary outcome [1] 1308 0
Postprandial normoglycaemia: Percent time spent with CGMS derived glucose reading between 4.0-10.0 mmol/l in the 3 hours post-prandial period
Timepoint [1] 1308 0
Secondary outcome [1] 2344 0
Postprandial hyperglycaemia: Percent time spent with CGMS derived glucose reading >/=10.1 mmol/l in 3 hour post-prandial period.
Timepoint [1] 2344 0
Secondary outcome [2] 2345 0
Postprandial hypoglycaemia: Percent time spent with CGMS </=3.9 mmol/l in 3 hour post-prandial period.
Timepoint [2] 2345 0
Secondary outcome [3] 2346 0
Postprandial glycaemic variation: 30 minutely Continuous Overlapping Net Glycaemic Action (CONGA) in 3 hour post-prandial period.
Timepoint [3] 2346 0

Eligibility
Key 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
Minimum age
6 Years
Maximum age
12 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Type of endpoint/s
Pharmacodynamics
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/02/2006
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
36
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 1082 0
Charities/Societies/Foundations
Name [1] 1082 0
Novo Nordisk Regional Diabtes Support Scheme Grant in Aid
Country [1] 1082 0
Australia
Primary sponsor type
Hospital
Name
Royal Children's Hospital, Parkville, Vic 3052.
Address
Country
Australia
Secondary sponsor category [1] 943 0
None
Name [1] 943 0
N/A
Address [1] 943 0
Country [1] 943 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 2387 0
Ethics Committee at Royal Children's Hospital
Ethics committee address [1] 2387 0
Ethics committee country [1] 2387 0
Australia
Date submitted for ethics approval [1] 2387 0
Approval date [1] 2387 0
Ethics approval number [1] 2387 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 35422 0
Address 35422 0
Country 35422 0
Phone 35422 0
Fax 35422 0
Email 35422 0
Contact person for public queries
Name 9960 0
Dr Michele O'Connell
Address 9960 0
Department of Endocrinology and Diabetes
Royal Children's Hospital
9th Floor
Main Building
Parkville VIC 3052
Country 9960 0
Australia
Phone 9960 0
+61 3 93455951
Fax 9960 0
+61 3 93477763
Email 9960 0
[email protected]
Contact person for scientific queries
Name 888 0
Dr Fergus Cameron
Address 888 0
Department of Endocrinology and Diabetes
Royal Children's Hospital
9th Floor
Main Building
Parkville VIC 3052
Country 888 0
Australia
Phone 888 0
+61 3 93455951
Fax 888 0
+61 3 93477763
Email 888 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
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