HEdia eXercise Algorithm - HEXA Study. A Randomised Controlled Crossover Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Time-in-range of Hedia Diabetes Assistant bolus calculator with physical activity module
研究概览
简要总结
A randomised controlled crossover pilot study to evaluate safety and efficacy of a digital insulin bolus calculator with a physical activity module
详细描述
Hedia Diabetes Assistant is a software device intended to monitor blood glucose and to support in the decision making of the optimal bolus insulin dose for management of insulin-dependent diabetes by providing the user with an indicative Bolus insulin dose.
This study has been designed to investigate the safety and efficacy of a digital insulin bolus calculator with a physical activity module that provides guidance on insulin reduction to patients with type 1 diabetes mellitus prior to and after exercise, based on exercise duration and intensity compared with the patients' habitual diabetes management.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Signed informed consent.
- •Ability to understand, speak and read Danish fluently.
- •Diagnosis of type 1 diabetes mellitus for ≥12 months.
- •Age between ≥18 and <60 years.
- •Minimum one measurement of HbA1c between 6.0 to 8.6 % (42 to 70 mmol/mol) within the last four months. If several measurements, then it is the latest one that counts.
- •Body mass index (BMI) between ≥18.5 and <30 kg/m
- •Ability to use an Apple® (iOS version 13 and up) or Android® (Android version 8.0 and up) smartphone.
- •Treated with the same pen-based insulin regimen with basal insulin (insulin glargine, degludec, or detemir) and meal time insulin (insulin aspart, lispro, glulisine) for at least the three preceding months.
- •Patients who can perform 45 min. of exercise at moderate intensity on an ergometer bike (investigator assessment).
- •If female participants of childbearing potential; willing to have a pregnancy test performed and to use a highly effective method of contraception.
排除标准
- •Already using Hedia Diabetes Assistant.
- •Use of human insulin or premixed insulin.
- •Blood pressure > 180/105 mmHg.
- •Treatment with sodium-glucose transporter 2-inhibitors, glucagon-like peptide 1 receptor agonists, or glucocorticoids.
- •Job situation entailing night shifts.
- •A mental state impeding compliance with the protocol.
- •Expected non-compliance with the protocol at the discretion of the principal investigator.
- •Pregnancy.
- •Breast-feeding.
- •Dialysis therapy or eGFR < 60 ml/min.
- •Patients diagnosed with claudicatio intermittens, heart failure, ischaemic heart disease or stroke.
- •Patients prescribed with beta blockers.
- •Abuse of alcohol or drugs in the past two years.
- •On-going participation, or participation within the last 3 months, in an organised clinical study in which participants received study medication (investigator assessment).
- •Surgery scheduled for the study duration period.
- •An episode of diabetic ketoacidosis or severe hypoglycaemia requiring third-party assistance within the preceding 6 months.
- •Known gastroparesis.
结局指标
主要结局
Time-in-range of Hedia Diabetes Assistant bolus calculator with physical activity module
时间窗: 24-hour period starting one hour before exercise
To compare the efficacy of the physical activity module as part of the Hedia Diabetes Assistant bolus calculator compared to the participants' habitual diabetes management during a 24-hour period starting one hour before exercise in adults with type 1 diabetes mellitus in terms of time-in-range (blood glucose 3.9-10.0 mmol/l).
次要结局
- Hypoglycemic events of Hedia Diabetes Assistant bolus calculator with physical activity module(24-hour period starting one hour before exercise)
- Time-below-range of Hedia Diabetes Assistant bolus calculator with physical activity module(24-hour period starting one hour before exercise)
- Time-above-range of Hedia Diabetes Assistant bolus calculator with physical activity module(24-hour period starting one hour before exercise)