DRKS00032570招募中Unknown
The impact of oral glucocorticoid exposure on insulin requirements in people with type 1 diabetes using an advanced hybrid-closed loop system, i.e. automated insulin delivery (AID) system – a randomized placebo- controlled experimental - CorDia
BaySpo, Sportwissenschaften IV - Exercise Physiology and Metabolism, Universität Bayreuth0 个研究点目标入组 11 人开始时间: 2023年8月31日最近更新:
适应症
试验速览
- 阶段
- Unknown
- 状态
- 招募中
- 发起方
- 入组人数
- 11
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized controlled study
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 18 Years 至 65 Years（—）
- 性别
- All
入选标准
- •Informed consent obtained from participants
- •Male or female aged 18-65 years (both inclusive)
- •Diagnosis of T1D for at least 2 years
- •Fasting C-peptide < 0,3 ng/ml
- •Use of an advanced hybrid-closed loop system, i.e. AID
- •system since at least one month
- •Time in range > 60% during the last 4 weeks prior to study enrolment
- •Stable and sufficient basal rate during the last 4 weeks as judged by the investigator in charge
- •HbA1c < 7,5% at screening
排除标准
- •Enrolement in another study
- •Hypoglycemic unawareness via gold score
- •Previous clinically relevant hypoglycaemia or diabetic ketoacidosis requiring third party help during the last 6 months
- •Known or suspected hypersensitivity to trial product(s) or related products
- •Receipt of any investigational medicinal product within 1 week prior to screening in this trial
- •Suffering from or history of a life-threatening disease (i.e. cancer judged not to be in full remission except basal cell skin cancer or squamous cell skin cancer), or clinically severe diseases that directly influence the study results, as judged by the Investigator. This does not prohibit the participation of patients with T1D or patients taking medications that influence the metabolism (e.g. statin) or cardio-respiratory system (e.g. asthma spray) as long as the therapy is stable and is not adapted throughout the run of the trial. Furthermore, it does not exclude patients who have celiac disease (or similar diseases or allergies), as long as the disease is stable and participants do not require specific medication (e.g. cortisone), and patients are able to stay on their specific (e.g.) gluten-free diet
- •Participant with a heart rate <35 beats per minute (bpm) at screening (after resting for 5 min in supine position)
- •Supine systolic or diastolic blood pressure at screening (after resting for 5 min in supine position) over 150 mmHg (hypertension threshold; excluding white-coat hypertension; therefore, if a repeated measurement on a second screening visit shows values within the range, the participant can be included in the trial). This exclusion criterion also pertains to participants being on anti-hypertensives.
- •Significant abnormal ECG at screening (as judged by the Investigator)
- •Any chronic (metabolic) disorder or severe disease (other than T1D) which, in the opinion of the investigator, might jeopardize participant’s safety or compliance with the protocol
- •History of any major cardiovascular disease or cancer
- •History of previous systemic GC-therapy lasting for more than 1 week
- •History of bone disease (e.g. osteoporosis, osteopenia, Mb. Paget)
- •History of multiple and/or severe allergies to drugs or foods or a history of severe anaphylactic reaction
- •Participants with mental incapacity or language barriers precluding adequate understanding or cooperation or who, in the opinion of their general practitioner or the investigator, are not able to meet the cognitive or language requirements of the study
- •Potentially non-compliant or uncooperative participants, as judged by the Investigator
- •Any condition that would interfere with trial participation or evaluation of results, as judged by the Investigator
- •Female participants of childbearing potential who are pregnant, breast-feeding or intend to become pregnant or who are not using adequate contraceptive methods (adequate contraceptive measures include sterilization, hormonal intrauterine devices, oral contraceptives, sexual abstinence or vasectomized partner; assessed at screening in a personal conversation).
研究者
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