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Trial registered on ANZCTR


Registration number
ACTRN12612000554864
Ethics application status
Approved
Date submitted
14/02/2012
Date registered
24/05/2012
Date last updated
24/05/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
Efficacy and acceptability of needles 4 mm length in pediatric insulin therapy
Scientific title
Pediatric patients affected by type 1 diabetes teaching to use 4 mm length needles for insulin therapy compared with diabetic children using 8 mm length needles regarding metabolic control parameters and quality of life
Secondary ID [1] 279720 0
Nil
Universal Trial Number (UTN)
U1111-1127-1444
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
type 1 diabetes 285556 0
risk of intramuscolar insulin injection 285557 0
Condition category
Condition code
Metabolic and Endocrine 285749 285749 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Use of 4 mm length needles for insulin administration for a period of 12 months, in newly type1 diabetic children or shift to 4 mm needles in patients undergoing therapy by 8 mm length needles; because the dosage of insulin should be adjusted according to blood glucose values, all patients are required to perform blood glucose testing at least 4 times/day and to apply a provided therapy algorithm
All patients and their parents will undergoing a 30 minutes instruction course, carried out by a trained nurse specialist, around the self-administration of insulin (if > 10 years old) or administration by parents (if < 10 years old), specifically aimed to the use of the needle of 4mm length
Intervention code [1] 284018 0
Treatment: Devices
Comparator / control treatment
Use of 8 mm length needles for insulin administration
Control group
Active

Outcomes
Primary outcome [1] 286296 0
average HbA1c from baseline, assessed by Siemens DCA Vantage Analizer
Timepoint [1] 286296 0
3,6,9, 12 months
Secondary outcome [1] 295558 0
Insulin/weight ratio, assessed on quarterly basis results of clinical examination and daily insulin requirements from glycemic diary
Timepoint [1] 295558 0
3, 6, 9, 12 months
Secondary outcome [2] 295559 0
Glycemic variability assessed by HBGI and LBGI evaluation of glucometer downloaded data (Accuchek SmartPix )
Timepoint [2] 295559 0
6, 12 months
Secondary outcome [3] 296092 0
Quality of life, assessed by Happy Face Rating Scale and Tuula-Maria Partanen questionnaire (Pract Diab Int april 2002 Vol. 19 No. 3)
Timepoint [3] 296092 0
6, 12 months

Eligibility
Key inclusion criteria
type 1 diabetes
Minimum age
2 Years
Maximum age
17 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
coeliac disease, thyroiditis, psichiatryc impairment, coagulation disease; HbA1c > 9,5% (except time of diagnosis)

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Therapy by 4 mm needles will be proposed to every newly diagnosed type 1 diabetes children treated at our regional centre and to all patients previously using 8 mm needles at periodic control time
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
na
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
1/04/2011
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment outside Australia
Country [1] 4051 0
Italy
State/province [1] 4051 0
Tuscany

Funding & Sponsors
Funding source category [1] 284522 0
Self funded/Unfunded
Name [1] 284522 0
Country [1] 284522 0
Italy
Primary sponsor type
Hospital
Name
AOU Meyer Children Hospital
Address
Viale Pieraccini 24 50139 Florence
Country
Italy
Secondary sponsor category [1] 283448 0
None
Name [1] 283448 0
Address [1] 283448 0
Country [1] 283448 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 286504 0
Meyer's Ethics Committee
Ethics committee address [1] 286504 0
Meyer Children Hospital, Viale Pieraccini 24 50139 Florence
Ethics committee country [1] 286504 0
Italy
Date submitted for ethics approval [1] 286504 0
Approval date [1] 286504 0
Ethics approval number [1] 286504 0

Summary
Brief summary
Availability of new, short length, 4 mm needles for insulin therapy could improve compliance in children with type 1 diabetes; however, there are some concerns about insulin leakage and efficacy of these devices.
We aim to test efficacy and assess satisfation of 4 mm length needles use in a population of children with newly diagnosed type 1 diabetes or previously undergoing insulin therapy four-time a day by 8-mm length needles
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 33625 0
Address 33625 0
Country 33625 0
Phone 33625 0
Fax 33625 0
Email 33625 0
Contact person for public queries
Name 16872 0
Lenzi Lorenzo
Address 16872 0
Meyer Children Hospital, Viale Pieraccini 24, 50139 Florence
Country 16872 0
Italy
Phone 16872 0
+39 055 5662570
Fax 16872 0
+39 055 5662486
Email 16872 0
[email protected]
Contact person for scientific queries
Name 7800 0
Lenzi Lorenzo
Address 7800 0
Meyer Children Hospital, Viale Pieraccini 24, 50139 Florence
Country 7800 0
Italy
Phone 7800 0
+39 055 5662570
Fax 7800 0
+39 055 5662486
Email 7800 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
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