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Trial registered on ANZCTR


Registration number
ACTRN12612001125819
Ethics application status
Approved
Date submitted
13/08/2012
Date registered
22/10/2012
Date last updated
22/10/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
Prospective evaluation of responses to hypoglycaemia in newly diagnosed young patients with type 1 diabetes: does intensive diabetes management prevent loss of glucagon response and hypoglycaemia awareness?
Scientific title
Prospective evaluation of responses to hypoglycaemia in newly diagnosed young patients with type 1 diabetes: does intensive diabetes management prevent loss of glucagon response and hypoglycaemia awareness?
Secondary ID [1] 273359 0
Nil
Universal Trial Number (UTN)
U1111-1125-7693
Trial acronym
IMS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Type 1 Diabetes Mellitus 279136 0
Condition category
Condition code
Metabolic and Endocrine 279327 279327 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The treatment group is treated with continuous subcutaneous insulin injection (CSII) starting at diagnosis of type 1 diabetes. The dose will vary from patient to patient and over time. Individual rates and factors will be calculated and adjusted for basal rate, insulin sensitivity and insulin:carbohydrate ratio for meals.
Participants of the treatment group will be in contact with the diabetes team as follows: Diabetes Nurse Educator (DNE) once weekly for first the 5 months, once every 2 weeks for the next 4 months and once per month until 18 months post diagnosis. Quality of life assessment will be at diagnosis, 3, 6,12 and 18 months later. Dietetic assessment will be at 1 and 12 months.
The counter regulatory response (glucagon, cortisol, adrenaline, growth hormone) to hypoglycaemia and c-peptide release will be assessed at three time points (6-11 weeks, 9 and 18 months). These visits include a hyperinsulinaemic clamp study, an arginine stimulation test and a meal challenge (standardised carbohydrate and protein-rich meal).
We used the following questionnaires:
- Hypoglycaemia: Hypoglycaemia Awareness Questionnaire/ modified Clarke's questionnaire (parent and child)
- Dietetic Questionnaires: A nutrition quiz was developed by the dieticians, one for pumpers and one for MDI patients. Each quiz consisted of 4 multi-part questions, with each question asking about a different nutrition knowledge area.
- Psychology Questionnaires
Child Questionnaires
- Strengths and Difficulties Questionnaire (S11-17, Robert Goodman 2002)
- Diabetes Quality of life for youth
- Self-efficacy for Diabetes Scale (SED)
- Diabetes Attitude Questionnaire (Att 19)
- McMasters Family Assessment Device
Parental Questionnaires
- Strengths and Difficulties Questionnaire (P11-17, Robert Goodman 2002)
- Diabetes Management Scale for Parents.
Intervention code [1] 283881 0
Treatment: Devices
Intervention code [2] 285289 0
Treatment: Drugs
Comparator / control treatment
Group on multiple daily insulin injections (MDI) as per departmental guidelines.
Control group
Active

Outcomes
Primary outcome [1] 287540 0
1. Counter regulatory hormones
Timepoint [1] 287540 0
Analysis during hypoglycaemic insulin clamps at three time points:
1. 6-11 weeks; 2. 9 months; 3. 18 months.
Primary outcome [2] 287541 0
2. Glycaemic control
Timepoint [2] 287541 0
HbA1c for CSII group 6 weekly; MDI group: 3 monthly until 18 months post diagnosis of type 1 diabetes.
Regular recording of episodes of hypoglycaemia at educator/ doctor appointments until 18 months post diagnosis of type 1 diabetes.
Secondary outcome [1] 298354 0
3. Quality of life assessment
Timepoint [1] 298354 0
Questionnaires at diagnosis, 3, 6,12,18 months.
Child Questionnaires
- Strengths and Difficulties Questionnaire (S11-17, Robert Goodman 2002)
- Diabetes Quality of life for youth
- Self-efficacy for Diabetes Scale (SED)
- Diabetes Attitude Questionnaire (Att 19)
- McMasters Family Assessment Device
Parental Questionnaires
- Strengths and Difficulties Questionnaire (P11-17, Robert Goodman 2002)
- Diabetes Management Scale for Parents
Secondary outcome [2] 298355 0
4. Dietetic assessment
Timepoint [2] 298355 0
Questionnaires at 1,12 months.
A nutrition quiz was developed by the dieticians, one for pumpers and one for MDI patients. Each quiz consisted of 4 multi-part questions, with each question asking about a different nutrition knowledge area.

Eligibility
Key inclusion criteria
Type 1 Diabetes
Minimum age
12 Years
Maximum age
16 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Existing psychopathology
Existing Family Stressors
Requiring interpreter
Existing seizure disorder
Any participant who has a hypoglycaemic seizure or is subsequently diagnosed with a seizure disorder will be withdrawn from the study.

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)
Recruitment on day 2 post diagnosis of type 1 diabetes. Randomisation using a sealed opaque envelope chosen in random order (Altman et al).
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a sealed opaque envelope chosen in random order (Altman et al).
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
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)

Funding & Sponsors
Funding source category [1] 285646 0
Charities/Societies/Foundations
Name [1] 285646 0
Juvenile Diabetes Research Foundation (JDRF)
Address [1] 285646 0
PO Box 481
Osborne Park WA 6917
Country [1] 285646 0
Australia
Primary sponsor type
Government body
Name
National Health and Medical Research Council (NHMRC)
Address
GPO Box 1421
Canberra ACT 2601
Country
Australia
Secondary sponsor category [1] 284481 0
None
Name [1] 284481 0
Address [1] 284481 0
Country [1] 284481 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 286324 0
Princess Margaret Hospital for Children Ethics Committee
Ethics committee address [1] 286324 0
Ethics Committee Secretary
Women's and Children's Health Service
GPO Box D184
PERTH WA 6840
Ethics committee country [1] 286324 0
Australia
Date submitted for ethics approval [1] 286324 0
28/04/2004
Approval date [1] 286324 0
15/07/2004
Ethics approval number [1] 286324 0
1015/EP

Summary
Brief summary
A major contributing factor to the vulnerability of patients with T1DM to hypoglycaemia is a defective counter-regulatory hormone response. It has been proposed that the loss of the glucagon response to hypoglycaemia is linked to the loss of the c-peptide. The aim of the study was to investigate whether tight glycaemic control from diagnosis can preserve the glucagon response to hypoglycaemia. Newly diagnosed adolescents with T1DM were randomly assigned to pump therapy with intensive management or MDI. Hypoglycaemic hyperinsulinaemic clamp studies were performed at 6 weeks, 9 months and 18 months after diagnosis. At each study session, glucagon response following 40 mins of hypoglycaemia and after arginine stimulation was assessed, as well as c-peptide response to a meal challenge. HbA1c was measured 3 monthly.
To analyse surrounding factors questionnaires on quality of life and diet were completed as well.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 33374 0
Address 33374 0
Country 33374 0
Phone 33374 0
Fax 33374 0
Email 33374 0
Contact person for public queries
Name 16621 0
Assoc Prof Elizabeth A Davis
Address 16621 0
Princess Margaret Hospital
Department of Endocrinology and Diabetes
Roberts Road
Subiaco, WA 6008
Country 16621 0
Australia
Phone 16621 0
+61893408090
Fax 16621 0
+61893408605
Email 16621 0
elizabeth.davis@health.wa.gov.au
Contact person for scientific queries
Name 7549 0
Assoc Prof Elizabeth A Davis
Address 7549 0
Princess Margaret Hospital
Department of Endocrinology and Diabetes
Roberts Road
Subiaco, WA 6008
Country 7549 0
Australia
Phone 7549 0
+61893408090
Fax 7549 0
+61893408605
Email 7549 0
elizabeth.davis@health.wa.gov.au

No data has been provided for results reporting
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