nderstanding the utilisation of an insulin-to-protein ratio in people with type 1 diabetes who follow a carbohydrate-restricted diet.
- Conditions
- Type 1 Diabetes MellitusMetabolic and Endocrine - Diabetes
- Registration Number
- ACTRN12619000208101
- Lead Sponsor
- Capital and Coast District Health Board
- Brief Summary
A total of 34 participants were recruited of which 16 were randomly assigned to the intervention group and 18 to the control group. There was one withdrawal from the intervention group and two withdrawals from the control group. The intervention group did not have any significant improvements in haemoglobin A1c, glycaemic variability, time spent in normal glycaemic range or hyperglycaemia compared with the control group. However, there was no significant increase in time spent in hypoglycaemia for either group. There were no significant changes in weight or BP for either group. Qualitative data indicated that some participants found the insulin-to-protein ratio helped them feel more in control of their diabetes while others found that it increased their distress.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 34
People with type 1 diabetes mellitus who follow a basal-bolus insulin regimen and attend diabetes clinics at Capital and Coast Health.
Pregnant or planning pregnancy
Breast-feeding
Unstable diabetes control (HbA1c>85 mmol/mol)
Kidney disease (EGFR<30 or on dialysis)
Hypoglycaemia unawareness, defined as a recurrent failure to detect a significant fall in blood glucose below normal levels
People who undertake more than 15 hours of moderate to intense exercise per week
History of gastroparesis
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method HbA1c at three months adjusted for baseline, assessed by blood test at Endocrine, Diabetes & Research Centre, CCDHB[Three months after randomisation]
- Secondary Outcome Measures
Name Time Method