diabetes diabetes mellitus type 1
Conditions
Interventions
For all participating subjects 4x 3mL blooddraw by Venapunction
Sponsors
Abbott Diabetes Care
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Difference between the Intervention and Control arm in the number of hours/day in hypoglycaemia (glucose | — |
Secondary
| Measure | Time frame |
|---|---|
| Visit 3 (Day 45) Interim Analysis (Intervention Arm Only) Difference in TIR defined as 3.9 to 10.0 mmol/L (70 to 180 mg/dL) in the 14 day period between Days 31 to 45 of Treatment Phase as compared to the Baseline phase (Days 1 to 15). Safety data will also be analysed and reported (includes AEs and insertion site signs and symptoms). Final Analysis (Intervention and Control Arms) o HbA1c o Proportion of subjects who achieve time spent in hypoglycaemia ( 10.0 mmol/L, 180 mg/dL) o Number and duration of hyperglycaemic episodes (> 13.3 mmol/L, 240 mg/dL) o Number of events of symptomatic hypoglycaemia o Post prandial hyperglycaemia (> 10.0 mmol/L, 180 mg/dL) o Number of episodes of DKA o Total daily dose of insulin o Prandial to basal insulin ratio o Number of subjects changing from once daily to twice daily basal insulin o Body weight and body mass index o Fasting cholesterol and triglycerides o Blood pressure o User questionnaire (subject [Intervention arm only] and health care professional facing) o Quality of Life/Patient Reported Outcome Measures (including Hypoglycaemia Fear Survey, diabetes treatment satisfaction questionnaire, diabetes distress scale, and diabetes quality of life) o Emergency room visits / admissions and non protocol related additional clinic time o Medication usage (non insulin related, including glucagon, self reported from event diary) o Number of blood glucose finger stick tests performed o Number of Sensor scans performed (Intervention arm only). Safety Endpoints o AEs o Sensor insertion site signs and symptoms. Additional Analyses o Subgroup analysis by MDI and CSII o All data from the 3 month time point will be analysed and reported for the primary endpoint and relevant secondary endpoints (excludes questionnaires and cholesterol and triglyceride measures) at study completion. | — |
Countries
Netherlands
Outcome results
None listed