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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
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
Secondary ID [1] 284200 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Type 1 Diiabetes Mellitus 291305 0
Condition category
Condition code
Metabolic and Endocrine 291658 291658 0 0
Diabetes

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 288898 0
Treatment: Other
Comparator / control treatment
Active control: Participants will be randomised to deliver each of the interventions once for each meal type
Control group
Active

Outcomes
Primary outcome [1] 300780 0
Continuous glucose monitoring will be worn to assess postprandial glycaemic excursions at 5 minute intervals from 0-300 minutes after the test meal
Timepoint [1] 300780 0
5 minute intervals from 0-300 minutes after the test meal
Secondary outcome [1] 330837 0
Postprandial blood glucose levels at 5 minute intervals from 0-300 minutes after the test meal
Timepoint [1] 330837 0
5 minute intervals from 0-300 minutes after the test meal
Secondary outcome [2] 330838 0
Percentage of time spent within blood glucose target range of 4-10mmol/L
Timepoint [2] 330838 0
5 minute intervals from 0-300 minutes after the test meal
Secondary outcome [3] 330839 0
Hypoglycaemic events defined as BGL <3.9mmol/L
Timepoint [3] 330839 0
Occurring at any timepoint to 300 minutes after the test meal

Eligibility
Key inclusion criteria
Type 1 Diabetes >1 year
Insulin pump therapy >6 months
Age 7-18 years
Minimum age
7 Years
Maximum age
18 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Coeliac disease
Major medical conditions

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer-generated
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
7/07/2014
Date of last participant enrolment
Anticipated
Actual
7/12/2015
Date of last data collection
Anticipated
Actual
31/01/2016
Sample size
Target
35
Accrual to date
Final
33
Recruitment in Australia
Recruitment state(s)
NSW,WA

Funding & Sponsors
Funding source category [1] 295367 0
Charities/Societies/Foundations
Name [1] 295367 0
Diabetes Australia Research Trust
Country [1] 295367 0
Australia
Primary sponsor type
Hospital
Name
John Hunter Children's Hospital
Address
Postal Address:
Locked Bag 1
Hunter Regional Mail Centre
NSW 2310

Office Location:
Lookout Road
New Lambton Heights
Newcastle NSW 2305
Country
Australia
Secondary sponsor category [1] 294190 0
None
Name [1] 294190 0
None
Address [1] 294190 0
None
Country [1] 294190 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 296699 0
Hunter New England Human Research Ethics Committee
Ethics committee address [1] 296699 0
Hunter New England Research Ethics & Governance Unit
Locked Bag 1
New Lambton NSW 2305
Ethics committee country [1] 296699 0
Australia
Date submitted for ethics approval [1] 296699 0
27/02/2014
Approval date [1] 296699 0
19/03/2014
Ethics approval number [1] 296699 0
4/03/19/4.02

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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 46690 0
Dr Prudence Lopez
Address 46690 0
John Hunter Children's Hospital
Locked Bag 1
Hunter Region Mail Centre
Newcastle NSW 2310
Country 46690 0
Australia
Phone 46690 0
+610249213000
Fax 46690 0
Email 46690 0
prudence.lopez@hnehealth.nsw.gov.au
Contact person for public queries
Name 46691 0
Dr Prudence Lopez
Address 46691 0
John Hunter Children's Hospital
Locked Bag 1
Hunter Region Mail Centre
Newcastle NSW 2310
Country 46691 0
Australia
Phone 46691 0
+610249213000
Fax 46691 0
Email 46691 0
prudence.lopez@hnehealth.nsw.gov.au
Contact person for scientific queries
Name 46692 0
Dr Prudence Lopez
Address 46692 0
John Hunter Children's Hospital
Locked Bag 1
Hunter Region Mail Centre
Newcastle NSW 2310
Country 46692 0
Australia
Phone 46692 0
+610249213000
Fax 46692 0
Email 46692 0
prudence.lopez@hnehealth.nsw.gov.au

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
SourceTitleYear of PublicationDOI
EmbaseA randomized comparison of three prandial insulin dosing algorithms for children and adolescents with Type 1 diabetes.2018https://dx.doi.org/10.1111/dme.13703
N.B. These documents automatically identified may not have been verified by the study sponsor.