None listed
Conditions
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.
Interventions
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
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.
Sponsors
National Health and Medical Research Council (NHMRC)
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
12 Years to 16 Years
Healthy volunteers
No
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.
Outcome results
None listed