Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12607000408482
Ethics application status
Not yet submitted
Date submitted
3/08/2007
Date registered
7/08/2007
Date last updated
7/08/2007
Type of registration
Prospectively registered

Titles & IDs
Public title
Is supper necessary to prevent overnight hypoglycaemia when using Lantus insulin?
Scientific title
Is supper required to prevent nocturnal hypoglycaemia in children with Type 1 Diabetes, when using basal-bolus insulin regimens with long and rapid-acting analogue insulins?
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Type 1 Diabetes 2199 0
Condition category
Condition code
Metabolic and Endocrine 2294 2294 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The proposed study will use Continuous Glucose Monitoring System (CGMS) devices to compare the nocturnal glycaemic outcomes of having a carbohydrate supper (control) versus having no supper (intervention) to determine whether a carbohydrate-containing snack before bed is required to prevent hypoglycaemia. Supper will consist of a dairy snack containing 15 grams of carbohydrate.
The study duration is 12 months.
Intervention code [1] 1914 0
Treatment: Other
Comparator / control treatment
Participants will have a 4 day wash-out period as they will be control for Monday, Tuesday, Wednesday of week one, and then be treatment for Monday, Tuesday, Wednesday of the following week (or vice versa with order of treatment first week and control second week).
Control group
Active

Outcomes
Primary outcome [1] 3184 0
The primary outcome measure will be the percentage of time hypoglycaemic (blood glucose level <4mmol/L).
Timepoint [1] 3184 0
Between 9pm and 7am during the 3-day treatment and control periods.
Secondary outcome [1] 5310 0
A secondary outcome from this study will be the percentage of time hyperglycaemic (blood glucose level >10mmol/L).
Timepoint [1] 5310 0
Between 9pm and 7am during the 3-day treatment and control periods.

Eligibility
Key inclusion criteria
Diagnosed with Type 1 Diabetes for greater than 1 year. Insulin regimen: established on a basal-bolus insulin regimen using glargine once daily and lispro/aspart (rapid-acting insulin) as evening bolus.HbA1c <8%Not currently on any other dietary restrictions.
Minimum age
10 Years
Maximum age
18 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
HbA1c > 8%Currently on other dietary restrictionsInsulin regimen: using isophane or other intermediate insulinsNon-English speaking.

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)
Allocation is not concealed. Eligible subjects from the diabetes database will be invited to participate in the study. Subjects will then be randomised to either the control group (supper) or treatment group (no supper) by coin toss. Subjects will then swap to the alternative group the following week, since they will act as their own control.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Coin toss will be used to randomly allocate whether each subject undergoes the control or treatment group first. This will be allocated as each subject is recruited.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Type of endpoint/s
Safety
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/10/2007
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
35
Accrual to date
Final

Funding & Sponsors
Funding source category [1] 2457 0
Charities/Societies/Foundations
Name [1] 2457 0
Pending: Application submitted to Dietetics Association of Australia: DAA-Vic Small Grants Program.
Country [1] 2457 0
Australia
Primary sponsor type
Individual
Name
Fergus Cameron
Address
Country
Secondary sponsor category [1] 2229 0
Individual
Name [1] 2229 0
Anna Barton
Address [1] 2229 0
Country [1] 2229 0
Secondary sponsor category [2] 2230 0
Individual
Name [2] 2230 0
Heather Gilbertson
Address [2] 2230 0
Country [2] 2230 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 4321 0
Royal Children's Hospital Human Ethics Research Committee
Ethics committee address [1] 4321 0
Ethics committee country [1] 4321 0
Date submitted for ethics approval [1] 4321 0
Approval date [1] 4321 0
Ethics approval number [1] 4321 0

Summary
Brief summary
Children with diabetes are currently recommended to have a carbohydrate supper before bed when using insulin injections. This is done to avoid overnight hypoglycaemia (blood glucose levels below 4mmol/L). This advice is based on using insulins such as Protaphane.
Some of the new insulins available, such as Lantus, do not have an action peak. With these new insulins, we think it is unlikely that a supper before bed is needed to prevent overnight hypoglycaemia. To our knowledge there are no research studies that have tested this idea.
This project looks at testing overnight blood glucose levels with and without supper, when using multiple daily injections of insulin that includes Lantus. The results of this study will help us to know whether supper is needed when using Lantus insulin.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 27728 0
Address 27728 0
Country 27728 0
Phone 27728 0
Fax 27728 0
Email 27728 0
Contact person for public queries
Name 11103 0
Anna Barton
Address 11103 0
Endocrinology and Diabetes Department
Royal Children's Hospital
Flemington Rd
Parkville VIC 3052
Country 11103 0
Australia
Phone 11103 0
03 9345 4216
Fax 11103 0
Email 11103 0
[email protected]
Contact person for scientific queries
Name 2031 0
Anna Barton
Address 2031 0
Endocrinology and Diabetes Department
Royal Children's Hospital
Flemington Rd
Parkville VIC 3052
Country 2031 0
Australia
Phone 2031 0
03 9345 4216
Fax 2031 0
Email 2031 0
[email protected]

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What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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