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Trial registered on ANZCTR


Registration number
ACTRN12614001198617
Ethics application status
Approved
Date submitted
4/11/2014
Date registered
14/11/2014
Date last updated
15/01/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
Insulin pump therapy for adolescents with type 1 diabetes and poor glycaemic control
Scientific title
Insulin pump therapy (Medtronic Veo) for adolescents aged 14 to 18 years with type 1 diabetes and poor glycaemic control (HbA1c greater than 10% for the previous 6 months) , a 12 month pilot study investigating the effect on HbA1c.
Secondary ID [1] 285592 0
nil
Universal Trial Number (UTN)
U1111-1163-6494
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Type 1 diabetes 293432 0
Condition category
Condition code
Metabolic and Endocrine 293705 293705 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
In this pilot interventional study, we will study patients with type 1 diabetes. They will recieve a 6 week education package on diabetes control and how to use an insulin pump. The education package will consisit of 4 x 2hour one on one sessions, three of which are with a diabetes nurse educator, and one with a dietician. The four sessions will be spread over 6 weeks and will occur at times that are convenient to the participant and health practitioner. They will be then started on an insulin pump and followed up for a period of 12 months.
We will use the Medtronic Veo insulin pump. This device delivers insulin in two ways: background basal insulin as a slow sub cutaneous infusion, and as bolus ammounts for carbohydrate that is eaten or to correct high blood glucose. The background basal rates and insulin bolus amounts are unique for each patient and are calculated by the team at pump start.
Participant compliance and progress will be monitored in their usual diabetes outpatient clinic by the paediatric endocrinologist.
Intervention code [1] 290541 0
Treatment: Devices
Comparator / control treatment
Standard treamtent will be compared by identifying matched controls within our diabetes database. Standard treatment is continuing on regular injected insulin. At each clinic appointment (every 3 months, or sooner if the clinician deems this necessary) they have access to the diabetes consultant, dietician, social worker and diabetes nurse educator.
They will be matched by HbA1c, gender, age, and length of time with diabetes.
Control group
Active

Outcomes
Primary outcome [1] 293514 0
HbA1c. HbA1c is measured at every clinic appointment (every 3 months, or sooner if the clinically indicated), by a point of care DCA 1000 analyzer.
Timepoint [1] 293514 0
12 months after starting insulin pump therapy
Secondary outcome [1] 311220 0
Episodes of diabetic ketoacidosis requiring hospital admission. Diabetic ketoacidosis is defined as having a blood glucose of greater than 11mmol/L, a venous pH less than 7.3, and the presence of blood or urine ketones.
Timepoint [1] 311220 0
Number of events over the 12 month study duration
Secondary outcome [2] 311221 0
Sever hypoglycaemia, defined by an episode resulting in seizure or coma requiring help by a third party
Timepoint [2] 311221 0
Number of events over the 12 month study duration
Secondary outcome [3] 311222 0
Patient satisfaction using insulin pump therapy, assessed using the validated "pump satisfaction questionnaire"
Timepoint [3] 311222 0
Assessed at the end of 12 months
Secondary outcome [4] 311223 0
Fear of hypoglycaemia assessed by the University of Virginia hypoglycaemia fear survey for adolescents.
Timepoint [4] 311223 0
Baseline and at 12 months
Secondary outcome [5] 311224 0
Hypoglycaemia awareness assessed by the modified Clarke hypoglycaemia awareness questionnaire.
Timepoint [5] 311224 0
Baseline and at 12 months
Secondary outcome [6] 311225 0
Problem Areas in Diabetes (psychosocial) assessment), assessed by the Problem Areas in Diabetes Questionnaire (DAWN)
Timepoint [6] 311225 0
Baseline and 12 months
Secondary outcome [7] 311226 0
Quality of Life, assessed using the validated PedsQL diabetes module Version 3.0
Timepoint [7] 311226 0
Baseline and at 12 months

Eligibility
Key inclusion criteria
1. Age 14 - 18 years with type 1 diabetes
2. Duration of diabetes at least 12 months
3. Insulin pump therapy naive
4. HbA1C>10% for the preceding 6 months
Minimum age
14 Years
Maximum age
18 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Pregnancy
2. Any additional condition(s) that in the investigator’s opinion would warrant exclusion from the study or prevent the subject from completing the study

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)
Patients currently being seen by the Princess Margaret Hospital diabetes and Endocrinology team who are aged 14 - 18 years and have an HbA1c of greater than 10% for the previous 6 months will be identified through our patient database.
Eligible patients will be offerred entry into the trial, and will be accepted in a first come first serve basis.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
This is a pilot study. Should we show improvement in glycaemia in the 12 month period we envisage designing an in clinic program that can be assessed prospectively in the future.
Phase
Phase 4
Type of endpoint(s)
Safety/efficacy
Statistical methods / analysis
Study participants will be matched 2:1 with active patients in our database (matched for HbA1c, age, and length of diabetes). We will use a student’s t test (2 tailed).

10 patients will be enrolled. This is assuming a mean baseline HbA1c of 11%, and a mean reduction of 1.5%, with an SD of 1.3%(see ref). This is based on a power calculation of 80%


REF: Johnson SR, Cooper MN, Jones TW, Davis EA. Long-term outcome of insulin pump therapy in children with type 1 diabetes assessed in a large population-based case–control study. Diabetologia. 2013;56(11):2392-400.

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
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)
WA
Recruitment hospital [1] 3114 0
Princess Margaret Hospital - Subiaco
Recruitment postcode(s) [1] 8863 0
6008 - Subiaco

Funding & Sponsors
Funding source category [1] 290185 0
Charities/Societies/Foundations
Name [1] 290185 0
Princess Margaret Hospital Foundation
Address [1] 290185 0
GPO box D184, Perth WA 6008
Country [1] 290185 0
Australia
Primary sponsor type
Individual
Name
Martin de Bock
Address
Princess Margaret Hospital
Roberts Road
Subiaco
Perth 6008
Western Australia
Country
Australia
Secondary sponsor category [1] 288897 0
Individual
Name [1] 288897 0
Elizabeth Davis
Address [1] 288897 0
Princess Margaret Hospital
Roberts Road
Subiaco
Perth 6008
Western Australia
Country [1] 288897 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 291895 0
Princess Margaret Hospital Ethics Committee
Ethics committee address [1] 291895 0
GPO box D184
Perth
WA 6840
Ethics committee country [1] 291895 0
Australia
Date submitted for ethics approval [1] 291895 0
15/10/2014
Approval date [1] 291895 0
20/11/2014
Ethics approval number [1] 291895 0

Summary
Brief summary
The study will let us explore the role of insulin pump therapy for adolescent with type 1 diabetes and poor control. These patients are often excluded from accessing this therapeutic tools due to concerns regarding safety, or because a lack of financial support. We will look at many outcomes including glycaemic control, episodes of diabetic ketoacidosis and severe hypoglycaemia, as well general quality of life and psychosocial functioning.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 52482 0
Dr Martin de Bock
Address 52482 0
Princess Margaret Hospital Roberts Road
Subiaco
Perth WA 6008
Country 52482 0
Australia
Phone 52482 0
+61 8 93407915
Fax 52482 0
Email 52482 0
martin.debock@health.wa.gov.au
Contact person for public queries
Name 52483 0
Dr Martin de Bock
Address 52483 0
Princess Margaret Hospital Roberts Road
Subiaco
Perth WA 6008
Country 52483 0
Australia
Phone 52483 0
+61 8 93407915
Fax 52483 0
Email 52483 0
martin.debock@health.wa.gov.au
Contact person for scientific queries
Name 52484 0
Dr Martin de Bock
Address 52484 0
Princess Margaret Hospital Roberts Road
Subiaco
Perth WA 6008
Country 52484 0
Australia
Phone 52484 0
+61 8 93407915
Fax 52484 0
Email 52484 0
martin.debock@health.wa.gov.au

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary