A randomised trial comparing the outcomes of specialist diabetes nurse advice to patients with insulin-treated diabetes and Diasend, a telehealth system, at home with a matched group of patients receiving advice based on a conventional, clinic-based approach

South West Yorkshire Partnership NHS Foundation Trust (UK)0 个研究点目标入组 294 人开始时间: 2012年9月19日最近更新: 2016年12月19日

适应症

试验速览

暂无简介。

•1. Type 1 (not receiving insulin via a pump) or insulin-treated type 2 diabetes with an HbA1c (documented within the previous 3 months) of between 7.5% (58 mmol/mol) and 11.0% (97 mmol/mol)
•2. Aged 21 years or more
•3. Duration of diabetes of at least 2 years
•4. BMI <40 kg/m2
•5. In patients with insulin-treated type 2 diabetes, oral medication (ie no changes in dosage) must have been stable for at least 6 weeks
•6. Able to attend clinic and be available for telephone consultations at the requisite times
•7. Able and willing to perform blood glucose monitoring using a blood glucose meter at least twice every other day and, ideally, four times daily
•8. Appropriate equipment at home to upload blood glucose levels to the Diasend web-site using the Diasend uploader
•9. Willing to monitor and record signs and symptoms of hypoglycaemia

•1. Type 1 diabetes receiving insulin via a pump
•2. Treatment with a glucagon-like peptide-1 (GLP-1) receptor agonist
•3. Pregnancy
•4. Disruption of liver (ALT and/or AST greater than three times the upper limit of normal at screening) or kidney (eGFR less than 50 mls/min/1.72m^2) function that might affect insulin action
•5. Clinically relevant cardiovascular, respiratory, hepatic, neurological, endocrine or other major disease making implementation of the protocol or interpretation of the study results difficult
•6. Any condition that, in the investigator?s judgement, is likely to cause the patient to be unable to understand the information in the Patient Information Sheet or provide informed consent or to cooperate fully with the protocol
•7. History of drug or alcohol abuse

发起方

South West Yorkshire Partnership NHS Foundation Trust (UK)