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?
Not Applicable
Completed
- Conditions
- Type 1 Diabetes MellitusMetabolic and Endocrine - Diabetes
- Registration Number
- ACTRN12612001125819
- Lead Sponsor
- ational Health and Medical Research Council (NHMRC)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 40
Inclusion Criteria
Type 1 Diabetes
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Any participant who has a hypoglycaemic seizure or is subsequently diagnosed with a seizure disorder will be withdrawn from the study.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
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. Counter regulatory hormones[Analysis during hypoglycaemic insulin clamps at three time points:<br>1. 6-11 weeks; 2. 9 months; 3. 18 months.];2. Glycaemic control[HbA1c for CSII group 6 weekly; MDI group: 3 monthly until 18 months post diagnosis of type 1 diabetes. <br>Regular recording of episodes of hypoglycaemia at educator/ doctor appointments until 18 months post diagnosis of type 1 diabetes.]
- Secondary Outcome Measures
Name Time Method 3. Quality of life assessment[Questionnaires at diagnosis, 3, 6,12,18 months.<br>Child Questionnaires<br>- Strengths and Difficulties Questionnaire (S11-17, Robert Goodman 2002)<br>- Diabetes Quality of life for youth<br>- Self-efficacy for Diabetes Scale (SED)<br>- Diabetes Attitude Questionnaire (Att 19)<br>- McMasters Family Assessment Device<br>Parental Questionnaires<br>- Strengths and Difficulties Questionnaire (P11-17, Robert Goodman 2002)<br>- Diabetes Management Scale for Parents];4. Dietetic assessment[Questionnaires at 1,12 months.<br>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.]