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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

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]

None

Universal Trial Number (UTN)

Trial acronym

HFHP MDI

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Type 1 Diabetes

Condition category

Condition code

Diet and Nutrition

Other diet and nutrition disorders

Metabolic and Endocrine

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]

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]

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]

30-minute interval from baseline (t=0) to 300 minutes post- test meal consumption.

Secondary outcome [1]

Peak interstitial glucose level assessed continuously for 5 hours post- meal consumption using a continuous glucose monitor.

Timepoint [1]

At the 5 hour assessment period

Secondary outcome [2]

Mean time to peak interstitial glucose level assessed continuously for 5 hours post- meal consumption using a continuous glucose monitor.

Timepoint [2]

peak interstitial glucose level assessed continuously for 5 hours post- meal consumption using a continuous glucose monitor.

Secondary outcome [3]

Hypoglycaemic episodes, defined as BGL < 3.5 mmol/L based on capillary glucose reading (finger stick measurement)

Timepoint [3]

At the 5 hour assessment period

Secondary outcome [4]

% 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]

Assessed continuously for 5- hours post meal consumption

Secondary outcome [5]

AUC at each 30- minute time frame assessed continuously for 5 hours post- meal consumption using a continuous glucose monitor.

Timepoint [5]

Every 30 minutes for 5 hours post meal consumption

Secondary outcome [6]

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]

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?

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

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

NSW

Recruitment hospital [1]

John Hunter Hospital Royal Newcastle Centre - New Lambton

Recruitment hospital [2]

John Hunter Children's Hospital - New Lambton

Recruitment postcode(s) [1]

2305 - New Lambton

Funding & Sponsors

Funding source category [1]

Charities/Societies/Foundations

Name [1]

Diabetes Australia

Address [1]

OFFICE: Level 1, 101 Northbourne Ave, Turner ACT 2612
POSTAL: PO Box 3156 Canberra ACT 2601

Country [1]

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]

Charities/Societies/Foundations

Name [1]

Australian Paediatric Endocrine Group

Address [1]

PO Box 180
Morisset NSW 2264
AUSTRALIA

Country [1]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Hunter New England Human Research Ethics Committee

Ethics committee address [1]

Research Ethics and Governance Office
The Lodge, Rankin Park Campus
Lookout Road,
New Lambton NSW 2305

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

30/06/2016

Approval date [1]

03/08/2016

Ethics approval number [1]

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

Prof Bruce King

Address

Department of Paediatric Endocrinology, Level 2, John Hunter Children's Hospital, Lookout Rd, New Lambton Heights, NSW, AUS, 2305

Country

Australia

Phone

+61 2 4042 0671

Fax

[email protected]

Contact person for public queries

Name

Tenele Smith

Address

Hunter Medical Research Institute (level 3 east), Lot 1 Kookaburra Ct, New Lambton Heights, NSW, AUS, 2305

Country

Australia

Phone

+61 2 4042 0848

Fax

[email protected]

Contact person for scientific queries

Name

Tenele Smith

Address

Hunter Medical Research Institute (level 3 east), Lot 1 Kookaburra Ct, New Lambton Heights, NSW, AUS, 2305

Country

Australia

Phone

+61 2 4042 0848

Fax

[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?

Doc. No.	Type	Citation	Link	Email	Other Details	Attachment
690	Ethical 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

Source	Title	Year of Publication	DOI
Embase	For 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.	2021	https://dx.doi.org/10.1111/dme.14512

N.B. These documents automatically identified may not have been verified by the study sponsor.

Trial Review

Documents added manually

Documents added automatically