Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12608000452392
Ethics application status
Approved
Date submitted
6/08/2008
Date registered
15/09/2008
Date last updated
9/01/2014
Type of registration
Prospectively registered

Titles & IDs
Public title
Use of glycaemic index knowledge to improve postprandial glycaemia in paediatric patients on insulin pump therapy - what proportion of the meal needs to be low glycaemic index for benefit to glycaemic outcome
Scientific title
The effect of varying glycaemic index (GI) content on Continuous Glucose Monitoring System (CGMS) measured postprandial glycaemic outcomes in children and adolescents with type 1 diabetes using insulin pump therapy
Secondary ID [1] 283879 0
Nil Known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
paediatric type 1 diabetes 3512 0
insulin pump therapy 3513 0
glycaemic index 3514 0
Condition category
Condition code
Metabolic and Endocrine 3666 3666 0 0
Diabetes
Diet and Nutrition 3776 3776 0 0
Other diet and nutrition disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
use of varying proportions of low glycaemic index food intakes to determine what proportion of the meal needs to be low GI for benefit to glycaemic outcome using CGMS measured blood glucose response and standard bolus dose feature on insulin pump. The criteria for varying glycaemic index intake was based on 25%, 50%, 75% and 100% of the carbohydrate food choices within the meal being low GI in content. An individual test meal is given for breakfast each morning, fasted from the previous night. The duration of the study is 5 half days within one week. Each subject acts as their own control when comparing the CGMS measured blood glucose response to the differing test meals.
Intervention code [1] 3231 0
Treatment: Other
Comparator / control treatment
cross-over trial so each subject acts as own control with varying meal GI content
Control group
Active

Outcomes
Primary outcome [1] 4571 0
percent time with CGMS measured glucose readings between 4.0-10.0 mmol/L in the 3-hours postprandial period
Timepoint [1] 4571 0
3 hours postprandial over 5 consecutive day period
Secondary outcome [1] 7729 0
percent time with CGMS measured glucose readings either > 10.1 mmol/L in the 3-hours postprandial period(hyperglycaemic)
Timepoint [1] 7729 0
3 hours postprandial over 5 consecutive day period
Secondary outcome [2] 7730 0
percent time with CGMS measured glucose readings either <4 mmol/L in the 3-hours postprandial period(hypoglycaemic)
Timepoint [2] 7730 0
3 hours postprandial over 5 consecutive day period

Eligibility
Key inclusion criteria
diagnosed type 1 diabetes > 1 year, established use of insulin pump therapy > 3 months, HbA1c < 8.6%
Minimum age
8 Years
Maximum age
18 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
non-english speaking families, diagnosed eating disorder, concomitant dietary restriction, use of other medication affecting blood glucose levels, presence of diabetes-related complications

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
All participants will be patients managed by the diabetes team at the Royal Children's Hospital, Melbourne and potential participants will be identified using the department’s records (eg patient database, records of patients using insulin pump devices etc). Preliminary information about the trial will be provided in the form of information sheets sent to all potential participants by mail; a letter from all researchers inviting participation will accompany this written information. As all researchers are members of the diabetes team at the Royal Children's Hospital, participants may be personally known to the researchers but this will not necessarily be the case. Information about the study (verbal and written information) will be available to potential participants at points of contact with the diabetes team – at outpatient clinic, nurse educators or dietetic visits and at insulin pump user support group meetings. All information will be accompanied by a statement that participation is voluntary and subject's decision on whether or not to participate will in no way influence the care received from the diabetes team. Subjects will be randomly allocated to the order in which they receive each test meal. This is a simple random allocation procedure performed prior to recruitment by the statistician using Stata10 statistical package with allocation assignment placed into a sealed opaque envelope that is not opened until each subject has been recruited and consented to the study. Each subject acts as their own control as is a cross-over trial
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation will be performed using simple random allocation derived from the computer statistical software Stata supplied by the hospital's statistical department Centre of Epidemiology and Biostatistics Unit (CEBU).
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
2/03/2009
Actual
18/05/2009
Date of last participant enrolment
Anticipated
Actual
1/02/2012
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] 3693 0
Other
Name [1] 3693 0
Diabetes Australia Research Trust
Country [1] 3693 0
Australia
Primary sponsor type
Hospital
Name
Royal Children's Hospital
Address
Department of Endocrinology and Diabetes
Flemington Road
Parkville Victoria 3052
Country
Australia
Secondary sponsor category [1] 3310 0
Hospital
Name [1] 3310 0
Royal Children's Hospital
Address [1] 3310 0
Department of Nutrition and Food Services
Flemington Road
Parkville Victoria 3052
Country [1] 3310 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 5739 0
Murdoch Children's Research Institute Human Research Ethics Committee
Ethics committee address [1] 5739 0
Murdoch Children's Research Institute
Flemington Road
Parkville Victoria 3052
Ethics committee country [1] 5739 0
Australia
Date submitted for ethics approval [1] 5739 0
07/08/2008
Approval date [1] 5739 0
12/03/2009
Ethics approval number [1] 5739 0
28108C

Summary
Brief summary
It is hypothesised that consideration of glycaemic index (GI) knowledge and the deliberate use of GI foods to modify low/high GI meals will improve post-prandial glycaemia in patients on insulin pump therapy. Aims: To investigate the effectiveness of clinical dietary advice regarding use of GI knowledge to improve PPG in pediatric patients with T1DM on insulin pump therapy; 1. To assess the clinical effectiveness of the dietary advice regarding the addition of a low GI food to a high GI meal to determine what proportion of the meal needs to contain low GI carbohydrates to improve postprandial glycaemic outcome.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 28813 0
Dr Heather Gilbertson
Address 28813 0
Department of Nutrition and Food Services, Royal Children's Hospital Melbourne, Flemington Rd, Parkville VIC
Country 28813 0
Australia
Phone 28813 0
+61 3 93459300
Fax 28813 0
+61 3 9345 6496
Email 28813 0
[email protected]
Contact person for public queries
Name 11970 0
Dr Heather Gilbertson
Address 11970 0
Department of Nutrition and Food Services
Royal Children's Hospital
Flemington Road, Parkville Victoria 3052
Country 11970 0
Australia
Phone 11970 0
+61 3 93459300
Fax 11970 0
+61 3 9345 6496
Email 11970 0
[email protected]
Contact person for scientific queries
Name 2898 0
Dr Heather Gilbertson
Address 2898 0
Department of Nutrition and Food Services
Royal Children's Hospital
Flemington Road, Parkville Victoria 3052
Country 2898 0
Australia
Phone 2898 0
+61 3 93459300
Fax 2898 0
+61 3 9345 6496
Email 2898 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
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.