None listed
Conditions
Brief summary
The best treatment for episodes of hypoglycaemia has not been studied in detail and most guidelines have a small evidence base. The study aimed to investigate whether using an individualised dose of glucose, based on weight, rather than a fixed dose of 15 g, as currently recommended, would be more effective in resolving hypoglycaemia. Adult subjects with T1DM and frequent hypoglycaemia (more than one per week) were enrolled into this study. Treatment for each hypoglycaemia episode, defined as capillary glucose <4.0 mmol/L, was randomly assigned one of three protocols: 0.2 grams/kg and 0.3 grams/kg or15 grams of glucose (Dextro glucose tablets). Each subject received each treatment in random order for up to 15 hypoglycaemia episodes. Glucose was re-tested 10 minutes after treatment, with a repeat dose if < 4 mmol/L. The study shows 0.3 g/kg treatment dose resulted in a greater change in glucose and higher glucose at 10 minutes, with less need for extra treatment.
Interventions
Randomised cross-over trial of 3 treatment doses of glucose for hypoglycaemia (0.2 g/kg, 0.3 g/kg and 15 g).
As per protocol each treatment is administered as glucose tablets at onset of spontaneously occurring hypoglycaemia, and only repeated at 10 minutes if hypoglycaemia has not resolved. As blood glucose is very dynamic "a wash-out" is not really applicable, and hypoglycaemia had always resolved prior to any repeat episodes. Patients record on the treatment sheet when an episode occurs, wha
Randomised cross-over trial of 3 treatment doses of glucose for hypoglycaemia (0.2 g/kg, 0.3 g/kg and 15 g). As per protocol each treatment is administered as glucose tablets at onset of spontaneously occurring hypoglycaemia, and only repeated at 10 minutes if hypoglycaemia has not resolved. As blood glucose is very dynamic "a wash-out" is not really applicable, and hypoglycaemia had always resolved prior to any repeat episodes. Patients record on the treatment sheet when an episode occurs, what treatment is given and then blood glucose at specified intervals - it si unlikely they would complete the data sheet without adhering to treatment for that episode.
Sponsors
Capital and Coast District Health Board, Wellington Hospital
Study design
Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Adults with type 1 diabetes, recieving insulin and having more than one episode of hypoglycaemia per week
Exclusion criteria
1. adrenal insufficiency 2. untreated hypothyroidism 3. clinical autonomic neuropathy 4. coeliac disease 5. Living alone
Outcome results
None listed