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Trial registered on ANZCTR
Registration number
ACTRN12617000292370
Ethics application status
Approved
Date submitted
17/01/2017
Date registered
24/02/2017
Date last updated
24/02/2017
Type of registration
Retrospectively registered
Titles & IDs
Public title
A comparison of three different insulin dosing algorithms for meals of variable macronutrient composition on postprandial glucose levels in paediatric type 1 diabetes
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Scientific title
A comparison of three different insulin dosing algorithms (carbohydrate counting, the Pankowska equation and the food insulin index) for meals of variable macronutrient composition on the postprandial blood glucose area under the curve in paediatric type 1 diabetes
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Secondary ID [1]
284200
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Nil
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Type 1 Diiabetes Mellitus
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Condition category
Condition code
Metabolic and Endocrine
291658
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0
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Diabetes
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
3 different insulin dosing algorithms will be compared:
1. Carbohydrate counting, where the participant determines the amount of carbohydrate in the meal and calculates the prandial insulin dose based on an individualised insulin: carbohydrate ratio
2. "Pankowska equation", where the carbohydrate content of the meal is used to determine the rapid insulin bolus dose, but the fat and protein content of the meal is also calculated as a "fat protein unit" which is then delivered as an extended insulin bolus
3. Food insulin index
During a one week run-in period participants will be contacted daily by the research team. The pre and postprandial blood glucose levels will be reviewed and the participants pre-existing insulin: carbohydrate ratio will be adjusted by the participants treating clinician if required.
The study is a crossover design with a single visit for each meal type for each insulin bolus. Subjects will be randomised to deliver either the high fat meal or the high protein meal for three consecutive days in week one. Subjects will then deliver the remaining meal for three consecutive days in week two
Insulin dose will be calculated according to insulin: carbohydrate ratio for the carbohydrate counting arm. For the Pankowska Equation (PE), fat protein units will be calculated by PE and ICR. Food insulin index doses will be derived from published food insulin demand data and adjusted according to ICR. The clinician will determine the insulin doses.
Insulin will be commenced 15 minutes prior to eating the test meal. Insulin will be delivered via insulin pump as a combination bolus with 60:40 split continued over 4 hours.
The high fat test meal is chicken nuggets and chips containing 2085kj, 47g carbohydrate, 16g protein, 27g fat. The high protein test meal is spaghetti bolognaise containing 1983kj, 48g carbohydrate, 34g protein, 13g fat.
Subjects will keep a food and activity diary throughout the study period.
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Intervention code [1]
288898
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Treatment: Other
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Comparator / control treatment
Active control: Participants will be randomised to deliver each of the interventions once for each meal type
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Control group
Active
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Outcomes
Primary outcome [1]
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Continuous glucose monitoring will be worn to assess postprandial glycaemic excursions at 5 minute intervals from 0-300 minutes after the test meal
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Assessment method [1]
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Timepoint [1]
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5 minute intervals from 0-300 minutes after the test meal
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Secondary outcome [1]
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Postprandial blood glucose levels at 5 minute intervals from 0-300 minutes after the test meal
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Assessment method [1]
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Timepoint [1]
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5 minute intervals from 0-300 minutes after the test meal
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Secondary outcome [2]
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Percentage of time spent within blood glucose target range of 4-10mmol/L
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Assessment method [2]
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Timepoint [2]
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5 minute intervals from 0-300 minutes after the test meal
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Secondary outcome [3]
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Hypoglycaemic events defined as BGL <3.9mmol/L
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Assessment method [3]
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Timepoint [3]
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Occurring at any timepoint to 300 minutes after the test meal
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Eligibility
Key inclusion criteria
Type 1 Diabetes >1 year
Insulin pump therapy >6 months
Age 7-18 years
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Minimum age
7
Years
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Maximum age
18
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
Coeliac disease
Major medical conditions
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer-generated
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Crossover
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Other design features
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Phase
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Date of first participant enrolment
Anticipated
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Actual
7/07/2014
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Date of last participant enrolment
Anticipated
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Actual
7/12/2015
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Date of last data collection
Anticipated
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Actual
31/01/2016
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Sample size
Target
35
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Accrual to date
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Final
33
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Recruitment in Australia
Recruitment state(s)
NSW,WA
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Funding & Sponsors
Funding source category [1]
295367
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Charities/Societies/Foundations
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Name [1]
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Diabetes Australia Research Trust
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Address [1]
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Postal Address:
PO Box 3156
Canberra ACT 2601
Office Location:
Level 1, 101 Northbourne Ave
TURNER ACT 2612
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Country [1]
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Australia
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Primary sponsor type
Hospital
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Name
John Hunter Children's Hospital
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Address
Postal Address:
Locked Bag 1
Hunter Regional Mail Centre
NSW 2310
Office Location:
Lookout Road
New Lambton Heights
Newcastle NSW 2305
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Country
Australia
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Secondary sponsor category [1]
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None
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Name [1]
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None
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Address [1]
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None
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Country [1]
294190
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
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Hunter New England Human Research Ethics Committee
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Ethics committee address [1]
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Hunter New England Research Ethics & Governance Unit
Locked Bag 1
New Lambton NSW 2305
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Ethics committee country [1]
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Australia
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Date submitted for ethics approval [1]
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27/02/2014
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Approval date [1]
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19/03/2014
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Ethics approval number [1]
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4/03/19/4.02
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Summary
Brief summary
Mealtime insulin dosing for type 1 diabetes is a challenging area of practice. Current insulin dosing adjusts the insulin amount dependent on the carbohydrate content of the meal (carbohydrate counting [CC]). Meals high in protein, fat and protein and fat have all been shown to increase postprandial glycaemia. Novel insulin algorithms have been developed to account for the glycaemic effect of fat and protein: Food insulin index (FII) and Pankowska Equation (PE).
Our study aimed to compare glycaemic outcomes for CC, FII and PE for a high protein and a high fat meal. Outcomes chosen included postprandial glucose excursions for 300 minutes following the test meal, postprandial blood glucose levels for 300 minutes following the test meal, percentage of time within target range (3.9-10mmol/L) and hypoglycaemic events.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Dr Prudence Lopez
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Address
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John Hunter Children's Hospital
Locked Bag 1
Hunter Region Mail Centre
Newcastle NSW 2310
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Country
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Australia
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Phone
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+610249213000
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Fax
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Email
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[email protected]
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Contact person for public queries
Name
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Dr Prudence Lopez
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Address
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John Hunter Children's Hospital
Locked Bag 1
Hunter Region Mail Centre
Newcastle NSW 2310
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Country
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Australia
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Phone
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+610249213000
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Name
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Dr Prudence Lopez
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Address
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John Hunter Children's Hospital
Locked Bag 1
Hunter Region Mail Centre
Newcastle NSW 2310
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Country
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Australia
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Phone
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+610249213000
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Fax
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Email
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[email protected]
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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
Source
Title
Year of Publication
DOI
Embase
A randomized comparison of three prandial insulin dosing algorithms for children and adolescents with Type 1 diabetes.
2018
https://dx.doi.org/10.1111/dme.13703
N.B. These documents automatically identified may not have been verified by the study sponsor.
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