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Trial registered on ANZCTR


Registration number
ACTRN12618002030257
Ethics application status
Approved
Date submitted
11/12/2018
Date registered
18/12/2018
Date last updated
17/02/2021
Date data sharing statement initially provided
18/12/2018
Date results information initially provided
17/02/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Insulin dosing for fat and protein in people with Type 1 Diabetes using insulin injections.
Scientific title
Determining an optimal insulin dosing strategy for a high fat, high protein meal in people with Type 1 Diabetes using multiple daily injection therapy.
Secondary ID [1] 290003 0
None
Universal Trial Number (UTN)
Trial acronym
HFHP MDI
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Type 1 Diabetes 300014 0
Condition category
Condition code
Diet and Nutrition 299908 299908 0 0
Other diet and nutrition disorders
Metabolic and Endocrine 309506 309506 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants will consume the same high fat, high protein breakfast meal with insulin on 4 consecutive mornings in the same week. Each morning the total amount of insulin given and/ the type of used and/ the timing insulin delivery is varied depending on the dosing schedule allocated.

The test meal will consist of a vanilla flavoured whey protein shake and a chocolate muesli bar (Carman's brand) and will contain 30g of carbohydrate, 40g of fat and 50g of protein and have a total energy content of 2707 kj.

Dosing conditions (1-4):

1. 100% of total rapid- acting insulin dose will be administered 15 minutes prior to test meal consumption via subcutaneous injection.
2. 125% of total rapid- acting insulin dose will be administered 15 minutes prior to test meal consumption via subcutaneous injection.
3. 125% of total short- acting insulin dose will be administered 15 minutes prior to test meal consumption via subcutaneous injection.
4. 100% of total rapid- acting insulin dose will be administered 15 minutes prior to test meal consumption via subcutaneous injection. An additional 25% of this dose will be administered 60 minutes post meal consumption.

Each participant will receive all 4 dosing conditions in random order using a block design.
Intervention code [1] 295711 0
Treatment: Drugs
Comparator / control treatment
100% of total rapid- acting insulin dose will be administered 15 minutes prior to test meal consumption via subcutaneous injection.
Control group
Dose comparison

Outcomes
Primary outcome [1] 299392 0
The primary outcome variable of this study is the mean post- prandial glucose excursion. Participant glucose levels will be monitored continuously for 5 hours post- meal consumption using a continuous glucose monitor.
Timepoint [1] 299392 0
30-minute interval from baseline (t=0) to 300 minutes post- test meal consumption.
Secondary outcome [1] 327029 0
Peak interstitial glucose level assessed continuously for 5 hours post- meal consumption using a continuous glucose monitor.
Timepoint [1] 327029 0
At the 5 hour assessment period
Secondary outcome [2] 327033 0
Mean time to peak interstitial glucose level assessed continuously for 5 hours post- meal consumption using a continuous glucose monitor.
Timepoint [2] 327033 0
peak interstitial glucose level assessed continuously for 5 hours post- meal consumption using a continuous glucose monitor.
Secondary outcome [3] 327034 0
Hypoglycaemic episodes, defined as BGL < 3.5 mmol/L based on capillary glucose reading (finger stick measurement)
Timepoint [3] 327034 0
At the 5 hour assessment period
Secondary outcome [4] 327035 0
% time in glucose target range (3.9-10 mmol/L) assessed continuously for 5 hours post- meal consumption using a continuous glucose monitor.
Timepoint [4] 327035 0
Assessed continuously for 5- hours post meal consumption
Secondary outcome [5] 327037 0
AUC at each 30- minute time frame assessed continuously for 5 hours post- meal consumption using a continuous glucose monitor.
Timepoint [5] 327037 0
Every 30 minutes for 5 hours post meal consumption
Secondary outcome [6] 327038 0
Time in postprandial hyperglycemia, defined as BGL >10 mmol/L, assessed continuously for 5 hours post- meal consumption using a continuous glucose monitor
Timepoint [6] 327038 0
Assessed continuously for 5- hours post meal consumption

Eligibility
Key inclusion criteria
Diagnosed with T1D for greater than 1 yr
Treated with multiple daily insulin injection therapy ( 4 injections/ day) for greater than 6 mo
Glycated haemoglobin less than or equal to 8.0% (64 mmol/mol)
Non- Obese
Minimum age
8 Years
Maximum age
40 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• Presence of any other major medical condition
• Allergies/ intolerances to dairy, nuts, fructose, soy products
• Evidence of complications of diabetes e.g. Gastroparesis
• Oral glycaemic medications

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)
None
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomised 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 interstitial glucose excursions between insulin regimes at a single time- point will be tested using a generalized linear mixed model with interstitial glucose excursion as the outcome of interest and insulin regime as the only predictor variable in the model (i.e. using a linear regression model but allowing for the correlation of repeated measurements on the same subjects).

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
21/01/2019
Actual
7/02/2019
Date of last participant enrolment
Anticipated
31/12/2019
Actual
1/04/2020
Date of last data collection
Anticipated
31/01/2020
Actual
8/04/2020
Sample size
Target
40
Accrual to date
Final
27
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 6536 0
John Hunter Hospital Royal Newcastle Centre - New Lambton
Recruitment hospital [2] 12699 0
John Hunter Children's Hospital - New Lambton
Recruitment postcode(s) [1] 14116 0
2305 - New Lambton

Funding & Sponsors
Funding source category [1] 294373 0
Charities/Societies/Foundations
Name [1] 294373 0
Diabetes Australia
Country [1] 294373 0
Australia
Primary sponsor type
Charities/Societies/Foundations
Name
Diabetes Australia
Address
OFFICE: Level 1, 101 Northbourne Ave, Turner ACT 2612
POSTAL: PO Box 3156 Canberra ACT 2601
Country
Australia
Secondary sponsor category [1] 293215 0
Charities/Societies/Foundations
Name [1] 293215 0
Australian Paediatric Endocrine Group
Address [1] 293215 0
PO Box 180
Morisset NSW 2264
AUSTRALIA
Country [1] 293215 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 295799 0
Hunter New England Human Research Ethics Committee
Ethics committee address [1] 295799 0
Research Ethics and Governance Office
The Lodge, Rankin Park Campus
Lookout Road,
New Lambton NSW 2305
Ethics committee country [1] 295799 0
Australia
Date submitted for ethics approval [1] 295799 0
30/06/2016
Approval date [1] 295799 0
03/08/2016
Ethics approval number [1] 295799 0
16/07/20/4.05

Summary
Brief summary
The aim of this study is to identify an insulin dosing strategy for people with T1D using MDI that will effectively control their blood glucose levels after eating meals high in fat and protein. Participation will involve consuming the same test meal for breakfast, a protein shake and a muesli bar on 4 mornings. Each morning participants will be allocated a different insulin dosing strategy. We hypothesise that increasing the insulin dose by 25% and extending the duration of insulin action by using regular human insulin will optimise blood glucose levels.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 68510 0
Prof Bruce King
Address 68510 0
Department of Paediatric Endocrinology, Level 2, John Hunter Children's Hospital, Lookout Rd, New Lambton Heights, NSW, AUS, 2305
Country 68510 0
Australia
Phone 68510 0
+61 2 4042 0671
Fax 68510 0
Email 68510 0
Bruce.King@henehealth.nsw.gov.au
Contact person for public queries
Name 68511 0
Miss Tenele Smith
Address 68511 0
Hunter Medical Research Institute (level 3 east), Lot 1 Kookaburra Ct, New Lambton Heights, NSW, AUS, 2305
Country 68511 0
Australia
Phone 68511 0
+61 2 4042 0848
Fax 68511 0
Email 68511 0
tenele.smith@newcastle.edu.au
Contact person for scientific queries
Name 68512 0
Miss Tenele Smith
Address 68512 0
Hunter Medical Research Institute (level 3 east), Lot 1 Kookaburra Ct, New Lambton Heights, NSW, AUS, 2305
Country 68512 0
Australia
Phone 68512 0
+61 2 4042 0848
Fax 68512 0
Email 68512 0
tenele.smith@newcastle.edu.au

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


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
690Ethical approval    371363-(Uploaded-11-12-2018-12-02-09)-Study-related document.pdf



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseFor a high fat, high protein breakfast, preprandial administration of 125% of the insulin dose improves postprandial glycaemic excursions in people with type 1 diabetes using multiple daily injections: A cross-over trial.2021https://dx.doi.org/10.1111/dme.14512
N.B. These documents automatically identified may not have been verified by the study sponsor.