Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12609000129280
Ethics application status
Approved
Date submitted
10/12/2008
Date registered
23/02/2009
Date last updated
23/02/2009
Type of registration
Retrospectively registered

Titles & IDs
Public title
Effective treatment of hypoglycaemia in children with type 1 diabetes: A randomised controlled clinical trial
Scientific title
Effective treatment of hypoglycaemia in children with type 1 diabetes: A randomised controlled clinical trial comparing glucose tablets, jellybeans, mentos dragess and orange juice for treatment of hypoglycaemia
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hypoglycaemia 4118 0
Condition category
Condition code
Metabolic and Endocrine 4313 4313 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Randomized treatment with:
Group1 - glucose tablets,
Group2 -Jellybeans,
Group3 -Mentos dragees
Group 4- orange juice

1. For each treatment group, the treatment is administered immediately upon identification of hypoglyacemia (blood glucose measured on optium glucometer < 4 mmol/L). 2. The treatment is a single treatment for each episode of hypoglycaemia (i.e. one treatment given immediately). If hypoglycaemia has not resolved by 15 minutes (after identification) a repeat treament is given.
3. Treatment is given at a blood glucose concentration of less than 4 mmol/L. Each treatment option is 0.3 g/kg of simple carbohydrate (as only one of the 4 treatment options is liquid, "concentration of glucose" is not relevant, and we have based the dose on amount of simple carbohydrate)
Intervention code [1] 3828 0
Treatment: Other
Comparator / control treatment
Comparison of 4 different active treatments:
Group1 - glucose tablets,
Group2 -Jellybeans,
Group3 -Mentos dragees
Group 4- orange juice
Control group
Active

Outcomes
Primary outcome [1] 5202 0
Change in blood glucose over 15 minutes, Measured using Optium blood glucose at 15 minutes compared with blood glucose measured by Optium glucometer at baseline
Timepoint [1] 5202 0
Baseline, 15 minutes
Secondary outcome [1] 8755 0
Proportion (number out of total) subjects with blood glucose above 4 mmol/L, measured by Optium glucometer
Timepoint [1] 8755 0
15 minutes

Eligibility
Key inclusion criteria
Child recieving insulin therapy
Attendance at National children's diabetes camp (for central region), held at Otaki health camp. Hypoglycaemic event (each event randomised to one of the four treatments)
Minimum age
8 Years
Maximum age
13 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Severe hypoglycaemia -i.e. with unconsciousness or a seizure (these will be treated with glucagon, as per standard management)

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)
Children attending diabetes camp will be invited to participate. Treatment assignment will be randomised at the time of each episode of hypoglycaemia by using a sealed envelope
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Colour coded sheets placed in envelopes, shuffled and randomly assiged to each group leader. At the time of hypoglycaemia an envelope will be randomly selected from that leader's envelopes
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
20/01/2008
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
160
Accrual to date
Final
Recruitment outside Australia
Country [1] 1466 0
New Zealand
State/province [1] 1466 0
Country [2] 1467 0
New Zealand
State/province [2] 1467 0

Funding & Sponsors
Funding source category [1] 4278 0
Charities/Societies/Foundations
Name [1] 4278 0
New Zealand Society for the Study of Diabetes (Eli Lilly Nursing research grant)
Country [1] 4278 0
New Zealand
Primary sponsor type
Individual
Name
Esko Wiltshire
Address
University of Otago Wellington
PO Box 7343
Wellington South 6021
Country
New Zealand
Secondary sponsor category [1] 3851 0
None
Name [1] 3851 0
Address [1] 3851 0
Country [1] 3851 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 6331 0
Central Regional Ethics Commitee
Ethics committee address [1] 6331 0
Ethics committee country [1] 6331 0
New Zealand
Date submitted for ethics approval [1] 6331 0
Approval date [1] 6331 0
09/10/2007
Ethics approval number [1] 6331 0
CEN/07/10/073

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 35032 0
Address 35032 0
Country 35032 0
Phone 35032 0
Fax 35032 0
Email 35032 0
Contact person for public queries
Name 12379 0
Esko Wiltshire
Address 12379 0
Department of Paediatrics
University of Otago Wellington
PO Box 7343
Wellington South 6021
Country 12379 0
New Zealand
Phone 12379 0
+64 4 3855999/6912
Fax 12379 0
+6443855898
Email 12379 0
[email protected]
Contact person for scientific queries
Name 3307 0
Esko Wiltshire
Address 3307 0
Department of Paediatrics
University of Otago Wellington
PO Box 7343
Wellington South 6021
Country 3307 0
New Zealand
Phone 3307 0
+64 4 3855999/6912
Fax 3307 0
Email 3307 0
[email protected]

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
SourceTitleYear of PublicationDOI
Dimensions AIEffective treatment of hypoglycemia in children with type 1 diabetes: a randomized controlled clinical trial2011https://doi.org/10.1111/j.1399-5448.2010.00725.x
N.B. These documents automatically identified may not have been verified by the study sponsor.