Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611001043921
Ethics application status
Not yet submitted
Date submitted
27/09/2011
Date registered
5/10/2011
Date last updated
5/10/2011
Type of registration
Prospectively registered

Titles & IDs
Public title
Evaluation of a tool to predict technology usage in youth with type 1 diabetes.
Scientific title
Evaluation of a tool to predict diabetes' technology usage in children and adolescents using, or about to commence, continuous subcutaneous insulin infusion (CSII) for type 1 diabetes mellitus.
Secondary ID [1] 273118 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Type 1 diabetes mellitus 270870 0
Condition category
Condition code
Metabolic and Endocrine 279048 279048 0 0
Diabetes

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Assessment of the ability of our questionnaire to predict users who will demonstrate recommended usage of their diabetes technology. This questionnaire is a composite of the most-weighted items from previously validated questionnaires widely used in the diabetes literature. Each of these questionnaires was designed to assess various individual characteristics e.g. family conflict/self-efficacy/personality factors that we have identified as having a robust reproducible impact on HbA1c or self-care. The questionnaire is designed to be completed by participants within 20-30 minutes. To show that this questionnaire is applicable to different kinds of diabetes technology, we will assess its ability to predict recommended usage of CGM after 3 months usage, and usage of CSII at 6 months after commencing. Usage of these technologies at these timepoints has been shown to be predictive of medium to long term usage.
50 Participants already using a CGM-compatible pump will be recruited to the CGM arm, where they will be provided with and shown how to use CGM for 3 months, after completing the questionnaire. Usage of >70% will be designated appropriate usage of CGM as this is the usage demonstrated to result in a clinically significant benefit of reduction in HbA1c of 0.5%. This can be downloaded from the device directly. After three months, the device will be returned and the participant's involvement in the study complete.
50 patients about to begin using insulin pump therapy (CSII) will also be recruited and asked to complete the questionnaire 6 weeks prior to starting the CSII 'pumpstart' program at our institution. Usage will be assessed from a pump download after 6 months and recommended usage will be designated as having >5 self-monitored blood glucose readings per day entered into the pump. This download will be assessed at a participant's routine outpatient appointment, which are scheduled every 3 months. After completing the questionnaire, participants in the CSII arm need not have any further contact with the study team.
These arms are independent of each other, but both are necessary to show that the questionnaire can apply to various types of advanced diabetes technology. The sensitivity and specificity of our questionnaire to predict usage will be our primary outcome.
Intervention code [1] 269459 0
Not applicable
Comparator / control treatment
Nil
Control group
Uncontrolled

Outcomes
Primary outcome [1] 279700 0
Sensitivity and specificity of the questionnaire (Qp) to predict low usage of technology (2 types being assessed in two arms - insulin pump and continuous glucose monitoring)
Low usage in the CGM arm will be usage of <70% as downloaded from the device. Low usage in the CSII arm will be designated as <5 blood glucose levels entered into the pump per day.
Timepoint [1] 279700 0
3 months for continuous glucose monitoring (CGM) arm.

6 months for continuous subcutaneous insulin infusion (CSII) arm.
Secondary outcome [1] 294254 0
The impact of usage on HbA1c
-Measurement of HbA1c at three months for the CGM arm and at three and six months for CSII arm
Timepoint [1] 294254 0
3 months for CGM arm, 6 months for CSII arm
Secondary outcome [2] 294255 0
The validity of a 5 minute doctor questionnaire (Qd) in predicting technology usage by participants
Timepoint [2] 294255 0
3 months for CGM arm, 6 months for CSII arm
-We will analyse the correlation of Qd with Qp and with HbA1c outcomes
Secondary outcome [3] 294256 0
Usage impact on variability of blood glucose (CGM arm) and percentage of blood glucose levels (BGLs) within target
-correlation of usage with blood glucose variability, as measured by the standard deviation of BGLs downloaded from the CGM
-correlation of usage with percentage of BGLs within target, information which is downloadable from both CGM and CSII
Timepoint [3] 294256 0
3 months for CGM arm, 6 months for CSII arm
Secondary outcome [4] 294257 0
Assessment of other measures of usage
Other usage : CGM
total number of sensors used
Other usage : CSII
number of boluses per day - [recommended no. = min. 4 per day]
recommended number of line changes being performed - [recommended = every 3 days]
frequency of contact with diabetes nurse educators
Timepoint [4] 294257 0
3 months for CGM arm, 6 months for CSII arm
Secondary outcome [5] 294341 0
Impact of usage on auxology
Timepoint [5] 294341 0
-We will analyse height, weight and BMI at study commencement and at 3 months (and six months in CSII group)

Eligibility
Key inclusion criteria
Inclusion Criteria
Patients will be considered eligible if they are :
-Over the age of 8yrs
-Have a diagnosis of Type 1 Diabetes Mellitus
-Have been using a Medtronic insulin pump compatible with the MiniLink CGM device for >6mths (CGM arm of study)
-Home computer with e-mail access
-English language comprehension
Minimum age
8 Years
Maximum age
20 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion Criteria
-Previous self-initiated use of a continuous glucose monitoring system (this does not exclude clinician initiated previous short term use of one sensor to elucidate glycaemic patterns)
-Concurrent dermatological disorder e.g. keloid propensity or previous documented hypersensitivity to medical adhesives
-Impaired vision such that the user would be unable to read the CGM data
-Other medical condition or use of a medication that in the judgement of the investigator could affect wearing of a CGM sensor on a daily basis
-Pregnancy

Study design
Purpose
Psychosocial
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/12/2011
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 269976 0
Commercial sector/Industry
Name [1] 269976 0
Medtronic Australasia
Country [1] 269976 0
Australia
Primary sponsor type
Hospital
Name
The Royal Childrens Hospital
Address
50 Flemington Road,
Parkville,
VIC 3052
Country
Australia
Secondary sponsor category [1] 268940 0
Charities/Societies/Foundations
Name [1] 268940 0
Murdoch Children's Research Institute
Address [1] 268940 0
50 Flemington Road,
Parkville,
VIC 3052
Country [1] 268940 0
Australia

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 271911 0
HREC, The Royal Children's Hospital
Ethics committee address [1] 271911 0
Ethics committee country [1] 271911 0
Australia
Date submitted for ethics approval [1] 271911 0
30/09/2011
Approval date [1] 271911 0
Ethics approval number [1] 271911 0

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

Contacts
Principal investigator
Name 33206 0
Address 33206 0
Country 33206 0
Phone 33206 0
Fax 33206 0
Email 33206 0
Contact person for public queries
Name 16453 0
Dr Orla Neylon
Address 16453 0
Dept. of Endocrinology & Diabetes,
The Royal Children's Hospital,
50 Flemington Road,
Parkville,
VIC 3052
Country 16453 0
Australia
Phone 16453 0
+61 3 9345 5951
Fax 16453 0
+61 3 9347 7763
Email 16453 0
[email protected]
Contact person for scientific queries
Name 7381 0
Dr Orla Neylon
Address 7381 0
Dept. of Endocrinology & Diabetes,
The Royal Children's Hospital,
50 Flemington Road,
Parkville,
VIC 3052
Country 7381 0
Australia
Phone 7381 0
+61 3 9345 5951
Fax 7381 0
+61 3 9347 7763
Email 7381 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
No additional documents have been identified.