Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12613001367730
Ethics application status
Approved
Date submitted
10/12/2013
Date registered
13/12/2013
Date last updated
26/02/2020
Date data sharing statement initially provided
26/02/2020
Date results provided
26/02/2020
Type of registration
Retrospectively registered

Titles & IDs
Public title
Food Insulin Index (FII) versus Traditional Carbohydrate Counting for Glycemic Control in Adults with Type 1 Diabetes.
Scientific title
Food Insulin Index (FII) versus Traditional Carbohydrate Counting for Glycemic Control in Adults with Type 1 Diabetes.
Secondary ID [1] 283746 0
Nil
Universal Trial Number (UTN)
Trial acronym
FOODII
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Type 1 Diabetes 290718 0
Condition category
Condition code
Metabolic and Endocrine 291084 291084 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
In this 3 month, parallel randomised controlled study in individuals with type 1 diabetes, we will compare two methods of adjusting the dose of insulin to match the nutrients in a meal. The intervention group will use a novel algorithm based on the food’s normal insulin response in healthy subjects (the Food Insulin Index or FII). Participants randomised to the FII intervention group will received 1x 2hr group education workshop, including presentation & discussion of relevant information, demonstration & practical activities on using FII counting and estimating food portion sizes; and 1x 30min individual appointment to reinforce the education and apply FII counting to individual food choices/preferences (note: diet not provided - subjects continue normal eating patterns). All education sessions will be delivered by an Accredited Practising Dietitian. Participants will be given a written education materials (pictorial reference book, pocket-sized reference book and session manual) and access to the study website and an iPhone app. Subjects are emailed weekly throughout the 3 month trial to see how they are going with the FII counting and offer assistance if needed. Glycosylated haemoglobin (HbA1c) and postprandial glycaemia and the occurrence of hypoglycaemia (recorded using a Continuous Glucose Monitoring System, CGMS) will be compared at baseline and after 3 months. We hypothesize that using the novel FII to adjust mealtime insulin dose will improve blood glucose control, compared with carbohydrate counting.
Intervention code [1] 288433 0
Treatment: Other
Comparator / control treatment
In this 3 month, parallel randomised controlled study in individuals with type 1 diabetes, we will compare two methods of adjusting the dose of insulin to match the nutrients in a meal. The control group will continue using traditional carbohydrate counting to estimate their mealtime insulin doses. Participants randomised to the control group will received 1x 2hr group education workshop, including presentation & discussion of relevant information, demonstration & practical activities on using carbohydrate counting and estimating food portion sizes; and 1x 30min individual appointment to reinforce the education and apply carbohydrate counting to individual food choices/preferences (note: diet not provided - subjects continue normal eating patterns). All education sessions will be delivered by an Accredited Practising Dietitian. Participants will be given a written education materials (pictorial reference book, pocket-sized reference book and session manual) and access to the study website and an iPhone app. Subjects are emailed weekly throughout the 3 month trial to see how they are going with their carbohydrate counting and offer assistance if needed. Glycosylated haemoglobin (HbA1c) and postprandial glycaemia and the occurrence of hypoglycaemia (recorded using a Continuous Glucose Monitoring System, CGMS) will be compared at baseline and after 3 months.
Control group
Active

Outcomes
Primary outcome [1] 291069 0
HbA1c
Timepoint [1] 291069 0
Assessed at baseline and after 3 months
Secondary outcome [1] 305963 0
Postprandial glycemic profile over 6 days using continuous glucose monitoring (CGMS) including mean blood glucose level, frequency of hypoglycaemia and hyperglycaemia and highest and lowest blood glucose levels and percentage and absolute time spent within normal, high and low blood glucose level ranges.
Timepoint [1] 305963 0
Assessed at baseline and after 3 months

Eligibility
Key inclusion criteria
1. age 18 - 65 years
2. type I diabetes diagnosed for 1 year or more
3. proficiency with bolus dose calculations (either manually or using insulin pump bolus calculator)
4. recent glycated hemoglobin level (a long term measure of diabetes control) between 7.0 to 9.5 %
5. reliably performing self-monitoring of blood glucose at least four times daily
6. able to speak and understand English fluently
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. pregnancy or lactation
2. mental impairments or disorders
3. eating disorders
4. medication that may influence blood glucose profile

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)
Potential participants will be recruited through private endocrinology clinics.

Potential participants will be identified using the clinic’s records. Preliminary information about the trial will either be mailed to potential participants or provided through a third-party not directly involved in the research or their medical care (e.g. the receptionist). Potential participants who are interested in the study will be invited to contact the researchers for more information and to enrol in the study.

Participants will be screened to ensure they meet the eligibility criteria and will be randomised using randomisation tables and sealed, opaque envelopes (preassigned and only opened at the time of randomisation).
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation sequence will be generated using randomisation tables and the outcome for each participant sealed in an opaque envelope prior to the commencement of recruiting for the study.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
There will be 36 subjects recruited for the study, with 18 subjects in each group. This number is sufficient to detect a 20% difference in mean glucose levels as determined by final continuous glucose monitoring output with 80% power and P less than 0.05 based on the previous research in similar patients. Data will be analysed using the SPSS statistical package version 19 (SPSS Inc., Chicago, IL, USA). Means, standard deviations for each variable at each timepoint and the change between time points will be calculated. Differences in coefficients will be considered statistically significant if P is less than 0.05, and highly significant if P is less than 0.01 (two-tailed).

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/05/2013
Actual
21/05/2013
Date of last participant enrolment
Anticipated
31/01/2014
Actual
9/09/2013
Date of last data collection
Anticipated
Actual
16/12/2013
Sample size
Target
36
Accrual to date
Final
26
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 288418 0
University
Name [1] 288418 0
The University of Sydney
Country [1] 288418 0
Australia
Primary sponsor type
University
Name
University of Sydney
Address
Human Nutrition Unit
School of Molecular Bioscience
Biochemistry Building (G08)
The University of Sydney NSW 2006
Country
Australia
Secondary sponsor category [1] 287124 0
None
Name [1] 287124 0
Address [1] 287124 0
Country [1] 287124 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 290295 0
University of Sydney Human Research Ethics Committee
Ethics committee address [1] 290295 0
Ethics committee country [1] 290295 0
Australia
Date submitted for ethics approval [1] 290295 0
16/11/2012
Approval date [1] 290295 0
11/01/2013
Ethics approval number [1] 290295 0
2012/2831

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 44906 0
Prof Jennie Brand-Miller
Address 44906 0
Human Nutrition Unit
School of Molecular Bioscience
Biochemistry Building (G08)
University of Sydney NSW 2006
Country 44906 0
Australia
Phone 44906 0
+61 2 9351 3759
Fax 44906 0
+61 2 9036 3024
Email 44906 0
[email protected]
Contact person for public queries
Name 44907 0
Jennie Brand-Miller
Address 44907 0
Human Nutrition Unit
School of Molecular Bioscience
Biochemistry Building (G08)
University of Sydney NSW 2006
Country 44907 0
Australia
Phone 44907 0
+61 2 9351 3759
Fax 44907 0
+61 2 9036 3024
Email 44907 0
[email protected]
Contact person for scientific queries
Name 44908 0
Jennie Brand-Miller
Address 44908 0
Human Nutrition Unit
School of Molecular Bioscience
Biochemistry Building (G08)
University of Sydney NSW 2006
Country 44908 0
Australia
Phone 44908 0
+61 2 9351 3759
Fax 44908 0
+61 2 9036 3024
Email 44908 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No/undecided IPD sharing reason/comment


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.