Type 2 Diabetes
Conditions
Interventions
A prospective, multi-centre, single group trial. Baseline phase (2 weeks) = Masked wear of the FreeStyle Libre Flash Glucose Monitoring System (Sensor results blinded to subject and health care prof
total expected duration of up to 3.5 months per subject.
Sponsors
Abbott Diabetes Care Ltd
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Type 2 diabetes on insulin therapy for >=6 months and on their current regimen for >=3 months prior to enrolment. Insulin must be one of the following; an injection regimen of: rapid-acting insulin at least once daily, or, rapid-acting insulin at least once daily plus basal insulin at least once daily, or, continuous subcutaneous insulin infusion (CSII) with no plans to change during the trial. HbA1c >=6.0% and <=9.0% at enrolment. Subject reports self-testing of BG levels on a regular basis equivalent to a minimum of 10 tests per week, for at least 2 months prior to enrolment. Aged 18 years or over. In the Investigator's opinion, the subject is proactive and therefore willing to modify their diabetes management. In the investigator's opinion, the subject is technically capable of using device.
Exclusion criteria
Exclusion criteria: Insulin regimen consists entirely of basal or bi-phasic insulin. Subject is currently prescribed animal insulin. Subject is currently prescribed oral, intra-articular, intramuscular or intravenous steroid therapy for any acute or chronic condition or requires it during the study period. Known (or suspected) allergy to medical grade adhesives. Currently participating in another device trial or drug study that could affect glucose measurements or glucose management. Currently using a Continuous Glucose Monitoring (CGM) device or FreeStyle Libre or has used one within the previous 4 months. Is planning to use a CGM device at any time during the trial. Total daily dose (TDD) of insulin >1.75 iu/kg at enrolment. Currently receiving dialysis treatment or planning to receive dialysis during the trial. Has experienced an acute myocardial infarction within previous 6 months. Has a concomitant disease or condition that may compromise patient safety, including and not limited to; unstable coronary heart disease, cystic fibrosis, severe mental illness, known or suspected eating disorder or any other uncontrolled long term medical condition. Has a pacemaker or any other neurostimulators. A female subject who is pregnant or planning to become pregnant within the trial duration. In the investigator's opinion, the subject is unsuitable to participate due to any other cause/reason.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from Baseline in time in hypoglycaemia (Sensor glucose <3.9 mmol/L [70 mg/dL]) at 2.5 months. | — |
Secondary
| Measure | Time frame |
|---|---|
| Change from Baseline for the following measures:Time in range (TIR) (Sensor glucose 70-180). Number and duration of hyperglycaemic episodes (Sensor glucose >180, 240 and 300). Number of hypoglycaemic episodes (Sensor glucose <70). Number and duration of hypoglycaemic episodes (Sensor glucose <55 and 45). Area under the curve (AUC) analysis for hypoglycaemic episodes (Sensor glucose <70, 55 and 45). Number, duration and AUC analysis of hypoglycaemic episodes by day (06:00 to 23:00) and night (23:00 to 06:00) (Sensor glucose <70, 55 and 45). Average Sensor glucose and variability measures (e.g. standard deviation [SD], Mean of Daily Differences [MODD], Low Blood Glucose Index [LBGI], High Blood Glucose Index [HBGI], Blood Glucose Risk Index [BGRI], SD of Glucose Rate of Change, Continuous Overall Net Glycaemic Action [CONGA]). Hypoglycaemia responders, defined as subjects achieving at least a 30% reduction in time in hypoglycaemia (Sensor glucose <70). TDD of insulin. Body weight and body mass index. Blood pressure. Sub-group analysis (e.g. age group [<65, >=65 years], duration of diabetes [<20, >=20 years). Additional analysis: Patient Reported Outcome (PRO) (Diabetes Treatment Satisfaction Questionnaire [DTSQ]). Number of Sensor scans performed. User Questionnaire summary. HCP Questionnaire summary. | — |
Countries
Japan
Contacts
Public ContactYushi Hirota
Kobe University Hospital Division of Diabetes and Endocrinology
Outcome results
None listed