nderstanding the utilisation of an insulin-to-protein ratio in people with type 1 diabetes who follow a carbohydrate-restricted diet.
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 入组人数
- 34
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 o limit（—）
- 性别
- All
入选标准
- •People with type 1 diabetes mellitus who follow a basal-bolus insulin regimen and attend diabetes clinics at Capital and Coast Health.
排除标准
- •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