To compare glycemic control and treatment satisfaction using a novel bolus insulin patch (Finesse) versus a pen for initiating and managing bolus insulin dosing in patients with T2DM not achieving glycemic targets on basal insulin with/without anti-hyperglycemic agents.
Patients sub-optimally controlled on basal insulin (with/without other antihyperglycemic agents (AHAs)) will be randomized 1:1 to either Finesse or pen to initiate bolus insulin dosing and followed for a 44-week intervention period. Patients will have both basal and bolus doses of insulin adjusted throughout the trial, as is clinically indicated, based on an easy to follow insulin dosing algorithm. After the final endpoint evaluation at week 44, patients will crossover to the alternate bolus insulin delivery device for 4 weeks and complete a patient preference survey at week 48.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
278
Change in A1C From Baseline to the Completion of 24 Weeks of Basal and Bolus Insulin Therapy
Change in A1C, with bolus insulin dosing with patch versus pen, from baseline to the completion of 24 weeks of basal and bolus insulin therapy
Time frame: 24 weeks
Number of Patients With A1C ≤7.0% at Week 24
Number of patients with A1C ≤7.0% at week 24
Time frame: 24 weeks
Change in Percent of Glucose Values of Continuous Glucose Monitoring (CGM) Measurements Within Targeted Range of 71 and 180 mg/dl (4.0 and 10.0 mmol/l) From Baseline to Week 24
Change in percent of glucose values of Continuous Glucose Monitoring (CGM) measurements within targeted range of 71 and 180 mg/dl (4.0 and 10.0 mmol/l) from baseline to week 24 (in a subset of patients)
Time frame: 24 weeks
Change in A1C From Baseline to Week 44
Change in A1C from baseline to the completion of 44 weeks of basal and bolus insulin therapy
Time frame: 44 weeks
Number of Patients With A1C ≤7.0% at Week 44
Number of patients with A1C ≤7.0% after 44 weeks of basal and bolus insulin therapy
Time frame: 44 weeks
Change in A1C From Week 24 to Week 44
Change in A1C from week 24 to week 44 after basal and bolus insulin therapy
Time frame: 44 weeks
Number of Participants With Severe Hypoglycemic Event
An event requiring the assistance of another person to actively administer carbohydrate (including IV dextrose), glucagon, or other resuscitative actions. Neurological recovery attributable to the restoration of plasma glucose to normal is considered sufficient evidence that the event was induced by a low plasma glucose concentration.
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...and 42 more locations
Time frame: 44 weeks