Study of PaQ™ (a Simple Patch on Insulin Delivery Device) in Patients With Type 2 Diabetes Mellitus

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the ability of a patient, who has type 2 diabetes (T2DM) who is currently treated with basal/bolus insulin therapy, to use PaQ™ (a simple patch on insulin delivery device) to control his/her blood glucose.

Detailed Description
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This is a single center, open label, feasibility of use and performance evaluation of PaQ™ (using insulin aspart) in patients with 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 four phases: screening, baseline evaluation, transition to PaQ™ use, 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.

Official Title
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A Study Evaluating the Feasibility of Use and Performance of PaQ™ in Patients With Type 2 Diabetes Mellitus Who Are Currently Treated With Basal/Bolus Insulin Therapy

Conditions
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Type 2 Diabetes Mellitus

Intervention / Treatment
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* Device: PaQ™ insulin infusion device


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male/female patient's ≥ 30 ≤ 65 years of age. Clinical confirmation of T2DM diagnosis by history and medication usage or glucose tolerance test. Currently treated with insulin using a basal/bolus regimen with or without concurrent use of OADs (metformin and/or glitazone). Currently on a stable insulin regimen as judged by the investigator (using an estimate of their basal dose of insulin does not fluctuate by more than ±10% every day) and if he/she is receiving a concurrent oral agent, the dose has remained unchanged for the last 30 days. Currently uses between 20 to 50 units/day basal insulin. Exclusion Criteria: Uncontrolled hyperglycemia, HbA1c > 9.0% requiring adjustment to his/her insulin regimen. Treated with premixed insulin, or neutral protamine hagedorn (NPH)/glargine/detemir insulin without use of bolus/meal time insulin. Patient has had an episode of severe (assisted) hypoglycemia within the past 30 days. Currently treated with sulfonylurea or incretin-based therapy [glucagon-like peptide-1(GLP-1) agonist or dipeptidyl peptidase-4 (DPP-4) inhibitor]. Total daily dose (TDD) of insulin is >100 units/day. Have a meal-time bolus doses that exceeds the capacity of the bolus Insulin Reservoir at any given meal. Have existing dermal irritation on their abdomen or have known hypersensitivity to skin adhesives. Taking or has taken prednisone or cortisone medications in the previous 30 days. Pregnant or is planning to become pregnant during the study period. Has severe medical or psychological condition(s) or chronic conditions/infections that in the opinion of the Investigator would compromise the patient's safety or successful participation in the study. Unable to follow the study clinical investigational plan (CIP)

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PaQ™ insulin infusion device<br>PaQ™ insulin infusion device which delivers rapid acting insulin. | Device: PaQ™ insulin infusion device<br>* Basal/bolus insulin therapy administered by CSII for 4 weeks. First two weeks is transition period to identify correct basal rate for the patient, second 2 weeks is treatment period to evaluate efficacy of CSII device.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patients ability to successfully assemble, fill, prime, apply and use the PaQ™ device |  | End of two week transition period | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Insulin usage | Average daily amount of basal insulin and meal time bolus insulin will be calculated | End of two baseline period and end of 2 week treatment period | 
| 7-point blood glucose reading | 7 - points are pre and 1.5 hours post each meal and at bedtime | Twice per week during baseline period (weeks 1 & 2) and PaQ™ Treatment period (weeks 5 & 6) | 
| Glucose variability | Continuous glucose monitoring (CGM) will be performed. Data stored in the CGM will be transferred to a computer at the end of each study period. Glucose variability during each time period will be calculated. | During baseline and PaQ™ treatment period | 
| Glucose exposure | Continuous glucose monitoring (CGM) will be performed. Data stored in the CGM will be transferred to a computer at the end of each study period. Glucose exposure during each time period will be calculated. | During baseline and PaQ™ treatment period | 
| Glucose Stability | Continuous glucose monitoring (CGM) will be performed. Data stored in the CGM will be transferred to a computer at the end of each study period. Glucose stability during each time period will be calculated. | During baseline and PaQ™ Treatment Period | 
| Infection at cannula insertion site |  | During transition and PaQ™ treatment period | 
| Occurence of adverse experiences and the number and severity of hypoglycemic episodes |  | During baseline, transition and PaQ™ treatment period | 
| Quality of Life Questionnaire |  | At the end of the study | 
| Dermal Irritation |  | During transition and PaQ™ treatment period |