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Trial registered on ANZCTR
Registration number
ACTRN12614000170628
Ethics application status
Approved
Date submitted
6/02/2014
Date registered
11/02/2014
Date last updated
11/02/2014
Type of registration
Retrospectively registered
Titles & IDs
Public title
Estimating Insulin Demand for Protein-Containing Foods
Using the Food Insulin Index
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Scientific title
Estimating Insulin Demand for Protein-Containing Foods
Using the Food Insulin Index compared to Traditional Carbohydrate Counting for Glycemic Control in Type 1 Diabetes.
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Secondary ID [1]
284043
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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 Diabetes
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Condition category
Condition code
Metabolic and Endocrine
291443
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Diabetes
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
In this randomised, crossover trial, 11 adults on insulin pump therapy consumed 6 individual foods (steak, battered fish, poached eggs, low fat yoghurt, baked beans and peanuts) with the insulin dose determined by the Food Insulin Index (FII) algorithm. Postprandial glycemia was measured in capillary blood glucose samples at 30 min intervals over 3 h. Researchers and participants were blinded to treatment. The order of the foods and algorithms was randomised and there was a 24 h washout period.
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Intervention code [1]
288737
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Other interventions
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Comparator / control treatment
In this randomised, crossover trial, 11 adults on insulin pump therapy consumed 6 individual foods (steak, battered fish, poached eggs, low fat yoghurt, baked beans and peanuts) in random order with the insulin dose determined by carbohydrate counting. Postprandial glycemia was measured in capillary blood glucose samples at 30 min intervals over 3 h. The order of the foods and algorithms was randomised and there was a 24 h Researchers and participants were blinded to treatment.
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Control group
Active
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Outcomes
Primary outcome [1]
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mean blood glucose level (assessed through capillary blood sampling)
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Assessment method [1]
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Timepoint [1]
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Assessed at 0, 30, 60, 90, 120, 150 and 180 min
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Secondary outcome [1]
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pre-prandial blood glucose level (assessed through capillary blood sampling)
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Assessment method [1]
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Timepoint [1]
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Assessed at baseline (0 min)
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Secondary outcome [2]
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change in blood glucose over 180 min (assessed through capillary blood sampling)
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Assessment method [2]
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Timepoint [2]
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Assessed at 0, 30, 60, 90, 120, 150 and 180 min
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Secondary outcome [3]
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peak blood glucose excursion (assessed through capillary blood sampling)
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Assessment method [3]
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Timepoint [3]
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Assessed at 0, 30, 60, 90, 120, 150 and 180 min
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Secondary outcome [4]
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time to peak blood glucose excursion (assessed through capillary blood sampling)
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Assessment method [4]
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Timepoint [4]
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Assessed at 0, 30, 60, 90, 120, 150 and 180 min
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Secondary outcome [5]
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mean amplitude of glycemic excursion (MAGE) (assessed through capillary blood sampling)
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Assessment method [5]
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Timepoint [5]
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Assessed at 0, 30, 60, 90, 120, 150 and 180 min
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Secondary outcome [6]
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number of hypoglycemia episodes (defined as blood glucose level less than or equal to 3.5 mmol/L) (assessed through capillary blood sampling)
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Assessment method [6]
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Timepoint [6]
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Assessed at 0, 30, 60, 90, 120, 150 and 180 min or if subject reported symptoms
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Eligibility
Key inclusion criteria
Aged between 18 to 70 years;
type 1 diabetes diagnosed for greater than or equal to 1 year;
use of insulin pump therapy, including proficiency with use of a bolus dose calculator for at least 3 months;
HbA1c between 6.0 and 8.5% (42 – 69mmol/mol);
reliably performing self-monitoring of blood glucose at least four times daily
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Minimum age
18
Years
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Maximum age
70
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
food allergies and/or intolerances
eating disorders
use of other medication that may influence blood glucose
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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)
Sealed envelopes were used to conceal the order of food and algorithm. Both researchers and participants were blinded to treatment.
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A computer-generated randomization table was used so that the order of food and algorithm was randomised.
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Crossover
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
Efficacy
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Statistical methods / analysis
Data were analyzed using the SPSS statistical package version 19 (SPSS Inc., Chicago, IL, USA). If the session was stopped due to hypoglycemia, the last recorded value was carried forward. A general linear model with pre-prandial blood glucose level as a covariate was used to analyze the following parameters for the two test algorithms: 1) pre-prandial blood glucose level, 2) mean absolute blood glucose level over 180 min, 3) change in blood glucose over 180 min, 4) peak blood glucose excursion, 5) time to peak blood glucose excursion, 6) mean amplitude of glycemic excursion (MAGE), 7) time to return to fasting blood glucose level, and 8) number of hypoglycemia episodes (defined as blood glucose level less than or equal to 3.5 mmol/L). Differences in coefficients were considered statistically significant if P was < 0.05, and highly significant if P was < 0.01 (two-tailed).
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Recruitment
Recruitment status
Completed
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Date of first participant enrolment
Anticipated
21/01/2013
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Actual
21/01/2013
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Date of last participant enrolment
Anticipated
30/04/2013
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Actual
25/03/2013
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Date of last data collection
Anticipated
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Actual
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Sample size
Target
11
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
NSW
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Funding & Sponsors
Funding source category [1]
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University
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Name [1]
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University of Sydney
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Address [1]
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City Rd
University of Sydney NSW 2006
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Country [1]
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Australia
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Primary sponsor type
University
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Name
University of Sydney
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Address
City Rd
University of Sydney NSW 2006
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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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Address [1]
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Country [1]
287377
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
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University of Sydney Human Research Ethics Committee
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Ethics committee address [1]
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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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Approval date [1]
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Ethics approval number [1]
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14175
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Summary
Brief summary
The Food Insulin Index (FII) is a novel algorithm for ranking foods based on insulin responses in healthy subjects relative to an isoenergetic reference food. Our aim was to compare postprandial glycemic responses in adults with type 1 diabetes who used both carbohydrate counting and the FII algorithm to estimate the insulin dosage for a variety of protein-containing foods.
Subjects/Methods: 11 adults on insulin pump therapy consumed 6 individual foods (steak, battered fish, poached eggs, low fat yoghurt, baked beans and peanuts) on two occasions in random order, with the insulin dose determined once by the FII algorithm, and once with carbohydrate counting. Postprandial glycemia was measured in capillary blood glucose samples at 30 min intervals over 3 h. Researchers and participants were blinded to treatment.
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Trial website
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Trial related presentations / publications
This study has been presented at the American Diabetes Association 73rd Scientific Sessions, Chicago, USA, 21-25 June 2013.
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Public notes
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Contacts
Principal investigator
Name
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Prof Jennie Brand-Miller
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Address
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Rm 472, Biochemistry Building (G08)
City Rd,
University of Sydney NSW 2006
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Country
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Australia
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Phone
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+61 2 9351 3759
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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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Prof Jennie Brand-Miller
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Address
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Rm 472, Biochemistry Building (G08)
City Rd,
University of Sydney NSW 2006
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Country
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Australia
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Phone
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+61 2 9351 3759
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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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Prof Jennie Brand-Miller
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Address
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Rm 472, Biochemistry Building (G08)
City Rd,
University of Sydney NSW 2006
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Country
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Australia
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Phone
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+61 2 9351 3759
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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
No additional documents have been identified.
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