The purpose of the study is to obtain an assessment (efficacy, safety, and patient reported outcomes) of basal bolus insulin delivery with PaQ in insulin-using patients with type 2 diabetes mellitus (T2DM).
This is a prospective, single center, open-label, uncontrolled study to assess the efficacy, safety, and patient reported outcomes of insulin delivery with PaQ® in patients with type 2 diabetes mellitus (T2DM) who are currently receiving basal/bolus insulin therapy with or without oral anti-diabetic drugs (OADs) for glycemic control. The patient's participation in the study is comprised of three phases: screening/baseline evaluation, transition to PaQ use and optimization, and PaQ treatment period. The use of these phases will allow an orderly transition to PaQ treatment as well as a reliable construct from which to interpret the final data.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
20
PaQ is a 3 day insulin delivery device which delivers U 100 rapid-acting insulin. Provides basal insulin at preset basal doses and bolus insulin (in 2 unit increments) with a push of a button.
a fast-acting analog of human insulin
Medical University of Graz
Graz, Austria
Glycosylated hemoglobin A1C (HbA1c) (obtained from venous blood)
Time frame: Change from Baseline at 12 weeks
Glycosylated hemoglobin A1C (HbA1c) (obtained from venous blood)
Time frame: Change from Baseline at 8 weeks
Fasting plasma glucose
Time frame: Change from Baseline at 12 weeks
7-point blood glucose profiles
Time frame: Change from Baseline at 12 weeks
Total daily dose of insulin
Time frame: Change from Baseline at 12 weeks
Body weight
Time frame: Change from Baseline at 12 weeks
Barriers to Insulin Treatment questionnaire
Measures aspects of psychological obstacles to insulin treatment in people with type 2 diabetes.
Time frame: Change from Baseline at 12 weeks
Diabetes Treatment Satisfaction Questionnaire
Designed to make the initial assessment of total diabetes treatment satisfaction, treatment satisfaction in specific areas, and perceived frequencies of hyperglycemia and hypoglycemia.
Time frame: Change from Baseline at 12 weeks
Short form 36 Health Survey
It is a generic measure, as opposed to disease specific, which assesses the relative burden of diseases, and differentiates the health benefits produced by a wide range of different treatments.
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Time frame: Change from Baseline at 12 weeks
Adverse events
Time frame: Collected throughout the study, average 14 weeks
Hypoglycemic events
Time frame: Collected at baseline (on current insulin therapy) and throughout the study, average 14 weeks