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Trial registered on ANZCTR

Registration number

ACTRN12612000609853

Ethics application status

Not yet submitted

Date submitted

6/06/2012

Date registered

7/06/2012

Date last updated

7/06/2012

Type of registration

Prospectively registered

Titles & IDs

Public title

What is the optimal insulin amplitude for a square wave bolus in people with type 1 diabetes

Scientific title

What is the optimal amplitude for a square wave bolus of insulin aspart in children and young people aged 7-35years to control postprandial hyperglycaemia (postprandial blood glucose excursion at 1 hour <3mmol/L)?

Secondary ID [1]

Nil

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

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

Type 1 diabetes

Condition category

Condition code

Metabolic and Endocrine

Diabetes

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

Continuous subcutaneous insulin infusion with insulin aspart

6 different bolus doses based on participants' individual insulin:carbohydrate ratios.
Dose 1: Standard bolus (rapid infusion) determined using participant's insulin:carbohydrate ratio
Dose 2: Insulin dose determined using 100% of participant's individual insulin:carbohydrate ratio delivered over 2 hours
Dose 3: Insulin dose determined using 50% of participant's individual insulin:carbohydrate ratio delivered over 2 hours
Dose 4: Insulin dose determined using 33% of participant's individual insulin:carbohydrate ratio delivered over 2 hours
Dose 5: Insulin dose determined using 25% of participant's individual insulin:carbohydrate ratio delivered over 2 hours
Dose 6: Insulin dose determined using 17% of participant's individual insulin:carbohydrate ratio delivered over 2 hours

After these doses participant's will return their insulin pump to their normal individually determined basal rate

This is a crossover study where each participant will receive each of the doses on different days. The study will be run over 6 days with the participants being given each different dose with their breakfast meal. For the remainder of the day the participants will use their usual basal settings with their usual boluses for meals.

Intervention code [1]

Treatment: Drugs

Comparator / control treatment

Dose 1 is standard dose of insulin aspart as determined using the participant's individual insulin:carbohydrate ratio delivered rapidly

Control group

Active

Outcomes

Primary outcome [1]

Postprandial blood glucose excursion
Continuous glucose monitoring system (CGMS) will be inserted on day 1 of the study to continously assess participants' blood glucose levels

Timepoint [1]

1 hour

Secondary outcome [1]

Rate of maximal blood glucose increase
CGMS will be inserted on day 1 of the study to continously assess participants' blood glucose levels

Timepoint [1]

4 hours

Secondary outcome [2]

Percent time in target BGL range
CGMS will be inserted on day 1 of the study to continously assess participants' blood glucose levels

Timepoint [2]

4 hours

Secondary outcome [3]

Maximal blood glucose excursion
CGMS will be inserted on day 1 of the study to continously assess participants' blood glucose levels

Timepoint [3]

4 hours

Secondary outcome [4]

Time to maximal blood glucose excursion
CGMS will be inserted on day 1 of the study to continously assess participants' blood glucose levels

Timepoint [4]

4 hours

Secondary outcome [5]

Time until blood glucose returns to baseline
CGMS will be inserted on day 1 of the study to continously assess participants' blood glucose levels

Timepoint [5]

4 hours

Secondary outcome [6]

Hypoglycaemic events
CGMS will be inserted on day 1 of the study to continously assess participants' blood glucose levels
Participants will also record their own BGLs according to standard practice. Standard practice typically involves 3 pre-meal BGL tests per day with 1 test prior to bed time/at suppertime.

Timepoint [6]

4 hours

Eligibility

Key inclusion criteria

Type 1 Diabetes Mellitus >/= 12 months
Insulin pump therapy >/= 6 months
Aged between 7 and 35 years
HbA1c </= 8% (no lower limit)

Minimum age

7 Years

Maximum age

35 Years

Sex

Both males and females

Can healthy volunteers participate?

Key exclusion criteria

BMI >91st percentile
Complications of their diabetes
Major medical problems

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 subjects approached at diabetic clinic and provided with information package and consent form.
Participants given computer generated code.
Code used for randomisation.
Participants give each of the 6 different doses and are randomised to which day to deliver each of the doses.
Allocation is not concealed

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

Upon generation of code participants will have computer-generated randomisation to deliver each of the 6 bolus doses on 6 different days.

Masking / blinding

Open (masking not used)

Who is / are masked / blinded?

Intervention assignment

Crossover

Other design features

Participants act as their own control as each participant gives each of the 6 different bolus doses

Phase

Phase 4

Type of endpoint/s

Safety/efficacy

Statistical methods / analysis

Recruitment

Recruitment status

Not yet recruiting

Date of first participant enrolment

Anticipated

30/07/2012

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)

Funding & Sponsors

Funding source category [1]

Commercial sector/Industry

Name [1]

NovoNordisk Regional Support Scheme grant

Address [1]

NovoNordisk Pharmaceutical Pty Ltd
Level 3
21 Solent Circuit
BAULKHAM HILLS NSW 2153

Country [1]

Australia

Primary sponsor type

Commercial sector/Industry

Name

NovoNordisk Regional Support Scheme grant

Address

NovoNordisk Pharmaceutical Pty Ltd
Level 3
21 Solent Circuit
BAULKHAM HILLS NSW 2153

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Not yet submitted

Ethics committee name [1]

Ethics committee address [1]

Ethics committee country [1]

Date submitted for ethics approval [1]

08/06/2012

Approval date [1]

Ethics approval number [1]

Summary

Brief summary

BACKGROUND:
In patients with type 1 diabetes insulin is required to control the rise in blood sugar levels that occurs after eating. Insulin boluses may be given in 3 main ways - a standard bolus (rapid bolus of insulin usually given just prior to a meal), a square wave bolus (a fixed dose of insulin given over a set period of time) or a dual wave bolus (a combination of the previous 2 boluses).

AIM:
To determine the amplitude (dose) required for a square wave insulin bolus of two hours duration to maintain blood glucose levels (glycaemic control) when a standard carbohydrate (60g) meal is eaten.


METHOD:
40 participants between the ages of 7 and 35 years with Type 1 Diabetes on insulin pump therapy will be recruited. The inclusion criteria are HbA1C </= 8%, Body Mass Index (BMI) <91st percentile, no complications of their diabetes and no other medical conditions. During a 1 week lead up to the study blood glucose control will be closely monitored. Participants will be contacted daily-2nd daily by a member of the research team. Adjustments may be made to the participant's insulin pump settings in conjunction with their treating endocrinologist. A continuous glucose monitoring system (CGMS) will be inserted on the first morning of the study. On this morning the participant will need to come to the hospital prior to breakfast. They will check their BGL 1 and 2 hours after insertion of CGMS for machine calibration. Participants will be provided with standard breakfast containing 60g of carbohydrate for each of the 6 days of the study. Insulin for the breakfast will be delivered as a square wave bolus over two hours starting just before the person starts eating. The bolus rate will be based on the participant's insulin: carbohydrate ratio and randomised each day to deliver a different percentage of this ratio (1:1 i.e 100% of the participant's insulin:carbohydrate dose for 2 hours, 1:2 i.e 50% of the participant's insulin:carbohydrate dose for 2 hours, 1:3, 1:4 and 1:6). The 6th bolus will be the participant’s standard bolus dose delivered as per usual practice. After the bolus is completed participants will return the pump to their usual basal rate. Participants should not eat until 4 hours after the test meal. Participants will self-monitor their blood glucose levels (BGLs) according to usual practice. If BGL is >18mmol/L at any time from >/= 4 hours after breakfast a correction bolus will be used. If the BGL goes below 3.5mmol/L or the participant has symptoms of hypoglycaemia at any time then they will eat 15 grams of carbohydrate.

OUTCOMES:
Primary outcome is the blood glucose excursion at 1 hour.
Secondary outcomes include maximal blood glucose increase, maximal blood glucose excursion, time to maximal blood glucose excursion, time in target blood glucose range, area under the curve and hypoglycaemic events.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Address

Country

Phone

Fax

Contact person for public queries

Name

Prudence Evans

Address

John Hunter Children's Hospital
Locked Bag 1
Hunter Region Mail Centre
NSW 2310

Country

Australia

Phone

+61249855634

Fax

prudence.evans@hnehealth.nsw.gov.au

Contact person for scientific queries

Name

Prudence Evans

Address

John Hunter Children's Hospital
Locked Bag 1
Hunter Region Mail Centre
NSW 2310

Country

Australia

Phone

+61249855634

Fax

prudence.evans@hnehealth.nsw.gov.au

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

Source	Title	Year of Publication	DOI
Dimensions AI	Extended insulin boluses cannot control postprandial glycemia as well as a standard bolus in children and adults using insulin pump therapy	2014	https://doi.org/10.1136/bmjdrc-2014-000050

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

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