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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
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.
Secondary ID [1] 284043 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Type 1 Diabetes 291099 0
Condition category
Condition code
Metabolic and Endocrine 291443 291443 0 0
Diabetes

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 288737 0
Other interventions
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.
Control group
Active

Outcomes
Primary outcome [1] 291425 0
mean blood glucose level (assessed through capillary blood sampling)
Timepoint [1] 291425 0
Assessed at 0, 30, 60, 90, 120, 150 and 180 min
Secondary outcome [1] 306741 0
pre-prandial blood glucose level (assessed through capillary blood sampling)
Timepoint [1] 306741 0
Assessed at baseline (0 min)
Secondary outcome [2] 306784 0
change in blood glucose over 180 min (assessed through capillary blood sampling)
Timepoint [2] 306784 0
Assessed at 0, 30, 60, 90, 120, 150 and 180 min
Secondary outcome [3] 306785 0
peak blood glucose excursion (assessed through capillary blood sampling)
Timepoint [3] 306785 0
Assessed at 0, 30, 60, 90, 120, 150 and 180 min
Secondary outcome [4] 306786 0
time to peak blood glucose excursion (assessed through capillary blood sampling)
Timepoint [4] 306786 0
Assessed at 0, 30, 60, 90, 120, 150 and 180 min
Secondary outcome [5] 306787 0
mean amplitude of glycemic excursion (MAGE) (assessed through capillary blood sampling)
Timepoint [5] 306787 0
Assessed at 0, 30, 60, 90, 120, 150 and 180 min
Secondary outcome [6] 306789 0
number of hypoglycemia episodes (defined as blood glucose level less than or equal to 3.5 mmol/L) (assessed through capillary blood sampling)
Timepoint [6] 306789 0
Assessed at 0, 30, 60, 90, 120, 150 and 180 min or if subject reported symptoms

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
Minimum age
18 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
food allergies and/or intolerances
eating disorders
use of other medication that may influence blood glucose

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)
Sealed envelopes were used to conceal the order of food and algorithm. Both researchers and participants were blinded to treatment.
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.
Masking / blinding
Blinded (masking used)
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
Intervention assignment
Crossover
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
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).

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
21/01/2013
Actual
21/01/2013
Date of last participant enrolment
Anticipated
30/04/2013
Actual
25/03/2013
Date of last data collection
Anticipated
Actual
Sample size
Target
11
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 288669 0
University
Name [1] 288669 0
University of Sydney
Country [1] 288669 0
Australia
Primary sponsor type
University
Name
University of Sydney
Address
City Rd
University of Sydney NSW 2006
Country
Australia
Secondary sponsor category [1] 287377 0
None
Name [1] 287377 0
Address [1] 287377 0
Country [1] 287377 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 290519 0
University of Sydney Human Research Ethics Committee
Ethics committee address [1] 290519 0
Ethics committee country [1] 290519 0
Australia
Date submitted for ethics approval [1] 290519 0
Approval date [1] 290519 0
Ethics approval number [1] 290519 0
14175

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.
Trial website
Trial related presentations / publications
This study has been presented at the American Diabetes Association 73rd Scientific Sessions, Chicago, USA, 21-25 June 2013.
Public notes

Contacts
Principal investigator
Name 46074 0
Prof Jennie Brand-Miller
Address 46074 0
Rm 472, Biochemistry Building (G08)
City Rd,
University of Sydney NSW 2006
Country 46074 0
Australia
Phone 46074 0
+61 2 9351 3759
Fax 46074 0
Email 46074 0
[email protected]
Contact person for public queries
Name 46075 0
Jennie Brand-Miller
Address 46075 0
Rm 472, Biochemistry Building (G08)
City Rd,
University of Sydney NSW 2006
Country 46075 0
Australia
Phone 46075 0
+61 2 9351 3759
Fax 46075 0
Email 46075 0
[email protected]
Contact person for scientific queries
Name 46076 0
Jennie Brand-Miller
Address 46076 0
Rm 472, Biochemistry Building (G08)
City Rd,
University of Sydney NSW 2006
Country 46076 0
Australia
Phone 46076 0
+61 2 9351 3759
Fax 46076 0
Email 46076 0
[email protected]

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