Adjustment of insulin Degludec to Reduce post-Exercise (nocturnal) hypoglycaeMia in people with diabetes – the ADREM study - ADREM

Radboud University Medical Center0 个研究点目标入组 18 人开始时间: 2019年12月10日最近更新: 2021年10月26日

适应症

试验速览

暂无简介。

•Adults with type 1 diabetes mellitus, 18-60 years
•Diabetes duration at least two years
•Treatment with long-acting insulin in combination with short-acting insulin analogue, according to basal-bolus regimen for at least one year
•Stable glycaemic control with HbA1c =75 mmol/mol (9%)
•At least one severe hypoglycaemia in the past year and/or =2 points on Dutch modified version of Clarke score or =3 points on Gold score
•Regularly engaging in exercise of moderate intensity or more (at least one hour per week)
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 18
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

•Microvascular complications, except background retinopathy or microalbuminuria
•History of cardiovascular disease, including heart failure, symptomatic cardiac valve disease and treatment-requiring arrhythmia
•Use of drugs affecting glucose metabolism other than insulin or metformin
•BMI >30 kg/m2
•Blood pressure >160/90 mmHg or use of blood pressure lowering drugs
•Pregnancy or the wish to become pregnant
•MDRD-GFR <60 ml/min/1.73 m2

发起方