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Trial registered on ANZCTR


Registration number
ACTRN12609001034224
Ethics application status
Approved
Date submitted
25/11/2009
Date registered
4/12/2009
Date last updated
9/07/2012
Type of registration
Prospectively registered

Titles & IDs
Public title
Dose Adjustment with Food Insulin Index: the DAFII study, comparing carbohydrate counting versus DAFII algorithm for estimating insulin dosage on measures of glycemic control in adults with type 1 diabetes consuming two different breakfast meals
Scientific title
To compare carbohydrate counting versus DAFII algorithm for estimating insulin dosage on measures of glycemic control in adults with type 1 diabetes consuming two different breakfast meals
Secondary ID [1] 1153 0
Nil
Universal Trial Number (UTN)
Trial acronym
DAFII study
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Type 1 diabetes 252287 0
Condition category
Condition code
Metabolic and Endocrine 252468 252468 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
In this within-subject crossover study, two methods of adjusting the dose of insulin to match the nutrients in a meal will be compared on measures of postprandial glycemia control in adults with type 1 diabetes. One method, known as carbohydrate counting, uses an algorithm (= formula) that matches the bolus insulin dose to the carbohydrate content of the meal. The other method uses a novel algorithm based on the food’s normal insulin response in healthy subjects (DAFII algorithm). Three meal and bolus-dose algorithm combined conditions will be administered in a random order to each participant who is an experienced insulin pump user on three consecutive days. The three test conditions are as follows: 1) meal A (54 g grain bread, 23 ml raspberry jam and 177 g canned peach in syrup), containing 83 g of carbohydrate + bolus algorithm using carbohydrate counting; 2) meal B (59 g croissant, 96 g yogurt and 48 g poached egg), containing 41 g of carbohydrate + bolus algorithm using carbohydrate counting; 3) meal B + bolus using DAFII algorithm. According to DAFII algorithm, meal A and B have the same bolus insulin dose because of the same insulin demand. Therefore only 3 test conditions will be in randomization.

The blood glucose levels after meal will be monitored using both a continuous glucose monitoring system (CGMS) and finger-prick blood testings with a blood monitor at regular intervals over the next 3 hours.
Intervention code [1] 241605 0
Treatment: Drugs
Intervention code [2] 241606 0
Treatment: Devices
Comparator / control treatment
Carbohydrate counting, a standard formula to adjust the bolus insulin dose, serves as the control.
Control group
Dose comparison

Outcomes
Primary outcome [1] 253342 0
Postprandial blood glucose profile measured by a continuous glucose monitoring system (CGMS)
Timepoint [1] 253342 0
Measured after an overnight fast (10 to 12 hours) and over 3 hours after starting eating the breakfast meal
Primary outcome [2] 253343 0
Postprandial blood glucose profile measured by testing finger-prick blood with a blood glucose monitor
Timepoint [2] 253343 0
Measured after an overnight fast (10 to 12 hours) and at regular intervals over 3 hours postprandially ( 30, 60, 90, 120, 150, 180 minutes)
Secondary outcome [1] 262420 0
Hypoglycemia occurrence measured by a continuous glucose monitoring system (CGMS)
Timepoint [1] 262420 0
Measured after an overnight fast (10 to 12 hours) and over 3 hours postprandially

Eligibility
Key inclusion criteria
Adult patients with type I diabetes diagnosed for more than 1 year, age 18 - 70 years; use of insulin pump therapy, for more than 3 months; recent glycated haemoglobin (HbA1C) less than 9.0 % and 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
Eating disorders; individuals using medication that may influence blood glucose profiles.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
An outside investigator who is not directly involved with the study will randomize the order of test meal/insulin dose algorithm combination for identification numbers and seal these in labelled opaque envelopes prior to the commencement of the study. After inclusion into the study, participants are given an identification number, which has a previously allocated randomised meal / dose algorithm order.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A randomisation digits table from a statistic book will be used to randomise the order of test meal / insulin dose algorithm combination for individual identification numbers.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
20/01/2010
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
35
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 256085 0
University
Name [1] 256085 0
The University of Sydney
Country [1] 256085 0
Australia
Primary sponsor type
University
Name
The University of Sydney
Address
Level 4, Molecular and Microbial Biosciences (MMB) building, G08 The University of Sydney, NSW 2006
Country
Australia
Secondary sponsor category [1] 251428 0
None
Name [1] 251428 0
Address [1] 251428 0
Country [1] 251428 0
Other collaborator category [1] 971 0
Individual
Name [1] 971 0
Dr Gabrielle Howard, Endocrinologist
Address [1] 971 0
Level 2, 27 Belgrave St, Manly, NSW, 2095
Country [1] 971 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 258177 0
Human Research Ethics Committee, the University of Sydney
Ethics committee address [1] 258177 0
Jane Foss Russell Building - G02
The University of Sydney NSW 2006
Ethics committee country [1] 258177 0
Australia
Date submitted for ethics approval [1] 258177 0
02/10/2009
Approval date [1] 258177 0
18/11/2009
Ethics approval number [1] 258177 0
11-2009/12211

Summary
Brief summary
In this within-subject crossover 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. One method, known as carbohydrate counting, uses an algorithm (= formula) that matches the dose of insulin to the carbohydrate content of the meal. The second method uses a novel algorithm based on the food’s normal insulin response in healthy subjects (the Food Insulin Index or FII). Participants who are experienced users of insulin pumps will consume three breakfast meals and apply different insulin to food algorithms on 3 consecutive test days. Their blood glucose levels will be monitored using a continuous glucose monitoring system (CGMS) and finger-prick blood testings with a blood monitor over the next 3 hours. We hypothesize that using the novel FII to adjust mealtime insulin dose will improve blood glucose readings (ie reduce hyperglycaemia) without increasing the risk of hypoglycaemia, compared with carbohydrate counting.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 30550 0
Address 30550 0
Country 30550 0
Phone 30550 0
Fax 30550 0
Email 30550 0
Contact person for public queries
Name 13797 0
Professor Jennie Brand-Miller
Address 13797 0
Room 472, Human Nutrition Unit, School of Molecular and Microbial Biosciences, G08, University of Sydney, NSW 2006
Country 13797 0
Australia
Phone 13797 0
+61 2 9351 3759
Fax 13797 0
+61 2 9351 6022
Email 13797 0
[email protected]
Contact person for scientific queries
Name 4725 0
Professor Jennie Brand-Miller
Address 4725 0
Room 472, Human Nutrition Unit, School of Molecular and Microbial Biosciences, G08, University of Sydney, NSW 2006
Country 4725 0
Australia
Phone 4725 0
+61 2 9351 3759
Fax 4725 0
+61 2 9351 6022
Email 4725 0
[email protected]

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
Dimensions AIImproving the Estimation of Mealtime Insulin Dose in Adults With Type 1 Diabetes The Normal Insulin Demand for Dose Adjustment (NIDDA) study2011https://doi.org/10.2337/dc11-0567
N.B. These documents automatically identified may not have been verified by the study sponsor.