Randomised Controlled Study to Evaluate the Impact of Novel Glucose Sensing Technology on Hypoglycaemia in Type 1 Diabetes.

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 84

Inclusion Criteria

o Diagnosed with Type 1 diabetes for * 5 years
o On their current insulin regimen for * 3 months prior to study entry
o Screening HbA1c result * 7.5% (58 mmol/mol)
o Reports self testing of blood glucose levels on a regular basis equivalent to a minimum of 3 times daily for at least 2 months prior to study entry
o In the investigator*s opinion the subject is considered technically capable of using the Abbott Sensor Based Glucose Monitoring System
o Aged 18 years or over.

Exclusion Criteria

o Subject has been diagnosed with hypoglycaemic unawareness (i.e. subject has a diagnosis of impaired awareness of hypoglycaemia recorded in their medical notes OR in the investigator*s opinion the subject currently experiences less than minimal warning symptoms for impending hypoglycaemia)
o Subject is currently prescribed animal insulin
o Subject is currently prescribed oral steroid therapy or is likely to require oral steroid therapy for any acute or chronic condition during the study
o Has known allergy to medical grade adhesives
o Currently participating in another device or drug study that could affect glucose measurements or glucose management
o Currently using a Continuous Glucose Monitoring (CGM) device or has used one within the previous 4 months
o Currently using Sensor augmented pump therapy
o Is planning to use a CGM device at any time during the study
o A female subject who is pregnant or planning to become pregnant within the study duration
o A breast feeding mother
o Currently receiving dialysis treatment or planning to
receive dialysis during the study
o Has a pacemaker
o Has experienced an acute myocardial infarction within previous 6 months
o Has a concomitant disease or condition that may compromise subject safety including; unstable coronary heart disease, cystic fibrosis, serious psychiatric disorder, or any other uncontrolled medical condition
o Has experienced an episode of confirmed or suspected diabetic ketoacidosis (DKA) in the previous 6 months
o In the investigator*s opinion, the subject is considered unsuitable for inclusion in the study for any other reason.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Difference between the Intervention and Control arm in the number of hours/day<br /><br>in hypoglycaemia (glucose < 3.9 mmol/L [70 mg/dL]) for the 14 day period at 6<br /><br>months (Visit 7 to Visit 8).</p><br>

Secondary Outcome Measures