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Trial registered on ANZCTR


Registration number
ACTRN12620000082909
Ethics application status
Approved
Date submitted
16/01/2020
Date registered
31/01/2020
Date last updated
31/01/2020
Date data sharing statement initially provided
31/01/2020
Date results information initially provided
31/01/2020
Type of registration
Retrospectively registered

Titles & IDs
Public title
How much additional insulin is needed for fat and protein meals in people with type 1 diabetes using insulin pumps.
Scientific title
Establishment of an insulin dosing schedule for high fat, high protein meals in individuals with type 1 diabetes using insulin pump therapy.
Secondary ID [1] 299809 0
Nil
Universal Trial Number (UTN)
Trial acronym
HFHP pump
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Type 1 Diabetes 315182 0
Condition category
Condition code
Metabolic and Endocrine 313499 313499 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This study involves the provision of the same high fat, high protein (40g fat, 50g protein) breakfast meal with insulin for 4 days (consecutive). The total amount of insulin administered on each of the 4 days will vary. Meal insulin will be calculated using the participant’s usual insulin to carbohydrate ratio (ICR), 100% (control), 120%, 140%, 160% ICR and given as a combination bolus split in a 60:40 ratio over 3 hours. Postprandial glucose will be measured using continuous glucose monitoring. Participants will consume the meal in the home setting and will be required to fast and avoid exercise for 6 h post meal.
Intervention code [1] 316060 0
Treatment: Drugs
Comparator / control treatment
individuals usual dose, 100% ICR
Control group
Dose comparison

Outcomes
Primary outcome [1] 322092 0
The primary outcome variable is mean postprandial glucose excursions from baseline to 360 mins.
Timepoint [1] 322092 0
difference in mean glucose excursions at 180 mins post- meal
Secondary outcome [1] 377307 0
Number of hypoglycaemic events defined as capillary blood glucose less than or equal to 3.5 mmol/L
Timepoint [1] 377307 0
monitored via continuous glucose monitoring at 5 min intervals from baseline to 360 mins

Eligibility
Key inclusion criteria
• T1DM for more than 1 year
• Using insulin pump therapy
• HbA1c less than or equal to 64 mmol/mol (8.0%)
• Body mass index less than the 95th percentile

Minimum age
8 Years
Maximum age
25 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• Coexisting medical problems
• Evidence of complications of diabetes incl gastroparesis
• Dietary restrictions (allergies/ intolerances) that prevent test meal consumption

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)
no
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
computerised sequence allocation using a block design
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
differences in mean glucose excursions between insulin dosing conditions at each 30 min interval will be tested using generalised linear mixed models.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD
Recruitment hospital [1] 15346 0
John Hunter Children's Hospital - New Lambton
Recruitment hospital [2] 15347 0
Lady Cilento Children's Hospital - South Brisbane
Recruitment postcode(s) [1] 28657 0
2305 - New Lambton
Recruitment postcode(s) [2] 28658 0
4101 - South Brisbane

Funding & Sponsors
Funding source category [1] 304269 0
Charities/Societies/Foundations
Name [1] 304269 0
Australasian Paediatric Endocrine Group
Address [1] 304269 0
PO Box 180
Morisset NSW 2264
Country [1] 304269 0
Australia
Primary sponsor type
Charities/Societies/Foundations
Name
Australasian Paediatric Endocrine Group
Address
PO Box 180
Morisset NSW 2264
Country
Australia
Secondary sponsor category [1] 305011 0
None
Name [1] 305011 0
Address [1] 305011 0
Country [1] 305011 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 304726 0
Hunter New England Research Ethics Committee
Ethics committee address [1] 304726 0
Research Ethics and Governance Office
Hunter New England Local Health District
Locked Bag 1
New Lambton NSW 2305
Ethics committee country [1] 304726 0
Australia
Date submitted for ethics approval [1] 304726 0
Approval date [1] 304726 0
07/03/2017
Ethics approval number [1] 304726 0

Summary
Brief summary
Research has shown that in addition to carbohydrate, fat and protein in foods cause a delayed rise in blood glucose. In some people with type 1 diabetes meals higher in fat and protein require extra insulin. This is a 4 day, home- based study looking at how much extra insulin to give for meals higher in fat and protein. We hypothesise that administration of an additional 60% of the meal insulin dose will reduce mean glucose excursions at 180 mins post- meal without an increase in hypoglycaemia.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 98010 0
Prof Bruce King
Address 98010 0
John Hunter Children's Hospital, Dept of Paediatric Endocrinology, Lookout Rd New Lambton Heights, NSW, 2305
Country 98010 0
Australia
Phone 98010 0
+61407838422
Fax 98010 0
Email 98010 0
bruce.king@health.nsw.gov.au
Contact person for public queries
Name 98011 0
Miss Tenele Smith
Address 98011 0
Hunter Medical Research Institute, Lot 1 Kookaburra Ct, New Lambton Heights, NSW, 2305
Country 98011 0
Australia
Phone 98011 0
+61 400416577
Fax 98011 0
Email 98011 0
tenele.smith@newcastle.edu.au
Contact person for scientific queries
Name 98012 0
Prof Bruce King
Address 98012 0
John Hunter Children's Hospital, Dept of Paediatric Endocrinology, Lookout Rd New Lambton Heights, NSW, 2305
Country 98012 0
Australia
Phone 98012 0
+61407838422
Fax 98012 0
Email 98012 0
bruce.king@health.nsw.gov.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Ethics approval stipulates that data may only be presented/ shared as de- identified group data.
What supporting documents are/will be available?
Ethical approval
Other
'Other' documents specified
Governance approval Lady Cilento Children's Hospital, Brisbane (now known as Queensland Children's Hospital)
How or where can supporting documents be obtained?
Type [1] 6435 0
Ethical approval
Citation [1] 6435 0
Link [1] 6435 0
Email [1] 6435 0
Other [1] 6435 0
Type [2] 6436 0
Other
Citation [2] 6436 0
Link [2] 6436 0
Email [2] 6436 0
Other [2] 6436 0
Summary results
Have study results been published in a peer-reviewed journal?
No
Other publications
Have study results been made publicly available in another format?
Yes
Results – basic reporting
Results – plain English summary