Prevention of Recurrent Severe Hypoglycaemia: a Definitive RCT Comparing Optimised MDI and CSII with or without Adjunctive Real-time Continuous Glucose Monitoring. - HypoCOMPASS v1.0

ewcastle upon Tyne Hospitals NHS Foundation Trust0 个研究点目标入组 100 人开始时间: 2010年3月17日最近更新: 2014年5月12日

适应症

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•1. Male or female aged 18-74 years inclusive at start of the trial.
•2. Diagnosis of diabetes mellitus according to ADA and WHO criteria and consistent with a clinical diagnosis of type 1 diabetes mellitus.
•3. Fasting serum C-peptide below the quality assured limit of detection for the assay and laboratory with simultaneous exclusion of biochemical hypoglycaemia (glucose <4.0 mmol/L) by laboratory glucose level analysis on a sample taken at the same time point.
•4. History of severe hypoglycaemia in the preceding one year (as defined by the American Diabetes Association : an event requiring assistance of another person to actively administer carbohydrate, glucagons or other resuscitative actions. These episodes may be associated with sufficient neuroglycopaenia to induce seizure or coma. Plasma glucose measurements may not be available during such an event, but neurological recovery attributable to restoration of plasma glucose to normal is considered sufficient evidence that the event was induced by low plasma glucose concentration) and / or impaired awareness of hypoglycaemia as confirmed by a score of = 4 in either the modified Clarke or Edinburgh hypoglycaemia awareness scores.
•5. Provision of informed consent
•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
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range

•1. Any condition that in the investigator’s judgement is likely to cause the subject to be unable to understand the information in the Informed Consent Document or provide informed consent.
•2. A level of English below that to enable the participant to understand both verbal and written information required by the study. Due to the complexity of the education programme to be given and the degree of training that the educators will need to give the programme it is not possible to invite patients to take part in this trial who in the opinion of the investigator do not have a sufficient level of understanding of English.
•3.Unwilling to undertake intensive insulin therapy including the use of CSII, optimised MDI regimen and use of real time continuous glucose monitoring.
•4. Unwilling to undertake glucose profiles using the subcutaneous continuous glucose monitoring (CGM) equipment.
•5. Unwilling to monitor home blood glucose levels at least 4 times daily.
•6. Unwilling or unable to monitor and record signs and symptoms of hypoglycaemia.
•7. A history of intolerance to insulin glargine.

发起方

ewcastle upon Tyne Hospitals NHS Foundation Trust