SMILE study (CEP311)
Research type
Research Study
Full title
Study of MiniMed™ 640G Insulin Pump with SmartGuard™ in prevention of Low Glucose Events in adults with Type 1 diabetes
IRAS ID
204170
Contact name
Pratik Choudhary
Contact email
Sponsor organisation
Medtronic
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
16/LO/0803,
Duration of Study in the UK
1 years, 0 months, 1 days
Research summary
Type 1 diabetes, caused by immune loss of insulin producing cells requires lifelong insulin therapy which must be adjusted in response to blood glucose levels, food and exercise. This requires frequent glucose monitoring, and places a large burden on the patient. An important barrier for managing the treatment of type 1 diabetes patients to achieve or maintain blood glucose levels within the normal range, is hypoglycaemia (Low blood sugar or glucose). Hypoglycemia events have been shown to disrupt sleep, impair memory, and cause inflammatory reactions, with impacts on driving, work and daily living.\n\nInsulin is usually delivered in multiple daily injections, but if this is unsuccessful in achieving required glucose control, insulin can be given via Continuous subcutaneous infusion (CSII) shown to improve control and reduce hypoglycaemia. Continuous glucose monitors, consisting of a small sensor that continuously monitors glucose levels can also be used in combination with the CSII. \n\nThis study will evaluate the efficacy of new sensor augmented pump, the 640G in preventing hypoglycaemic events in comparison with currently available (CSII) in adults aged 24-75. The Sensor Augmented pump has the additional capacity to prevent hypoglycaemia using the SmartGuard feature, this is a predictive algorithm that can suspend insulin delivery when it detects the patients sensor glucose value is predicted to reach or fall below a pre-set low glucose limit within 30 minutes. To use the smart guard feature the Minimed 640g pump works in conjunction with the sensor (Enlite 3) and transmitter (GST3C), together they are referred to as Continuous Glucose Monitoring (CGM). The Enlite 3 sensor and GST3C transmitter are both investigational devices and are not currently CE marked or commercially available.
REC name
London - South East Research Ethics Committee
REC reference
16/LO/0803
Date of REC Opinion
25 May 2016
REC opinion
Favourable Opinion