A Prospective Observational Study to Assess Insulin Delivery With PaQ® in Patients With Type 2 Diabetes Mellitus

Study Overview
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Brief Summary
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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).

Detailed Description
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This is a prospective, single center, post-market observational 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.

Official Title
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A Prospective, Single Center, Post-Market Observational Study to Assess the Efficacy, Safety, and Patient Reported Outcomes of Insulin Delivery With PaQ® in Patients With Type 2 Diabetes Mellitus

Conditions
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Type 2 Diabetes Mellitus

Intervention / Treatment
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* Device: PaQ® Insulin Delivery Device


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Is at least 18 years of age Has a clinical diagnosis of T2DM, as determined by clinical history and medication usage Has an A1C ≥ 7.0% and ≤ 11.0%; Is treated with basal-bolus insulin therapy (at least 2 injections per day) with or without OADs, and/or glucagon-like peptide-1 (GLP-1) agonist for at least 3 months and has not had a change (addition or discontinuation of existing drug or change in dose) in their OADs for the last 8 weeks Determined by the investigator that insulin requirements to achieve glycemic targets can be met by the insulin capacity of the PaQ device If on concomitant metformin, has serum creatinine <1.5 mg/dL (male) or <1.4 mg/dL (female) If female, and of child-bearing potential, has a negative urine pregnancy test at screening and must be using adequate means of contraception as determined by the Investigator Is clinically euthyroid as judged by the Investigator Is able to understand and sign the required study documents and comply with the clinical investigational plan (CIP) requirements Is deemed capable by the Investigator to perform the requirements of the CIP, including use of PaQ, frequent self-monitoring of blood glucose Exclusion Criteria: Is poorly compliant with the currently prescribed diabetes regimen, as determined by the Investigator Is poorly compliant with prescribed self-monitoring of blood glucose, as determined by the Investigator Is currently taking or has taken sulfonylureas within the last 2 months Has a BMI greater than 40 kg/m2 Has experienced recurrent severe hypoglycemia (> 2 episodes) requiring assistance during the past 6 months Has existing dermal irritation/inflammation over the abdominal area that may interfere with use of PaQ, as determined by the Investigator Has known clinically significant hypersensitivity to skin adhesives Is female and if of child-bearing potential, is pregnant, lactating, or planning to become pregnant Is currently being treated with or expected to require or undergo treatment with systemic steroids by oral, intravenous, or intramuscular route (inhaled with low systemic exposure is permitted) Currently abuses drugs or alcohol or has a history of abuse that in the Investigator's opinion would cause the individual to be non-compliant Has received any investigational drug within 1 month Has donated blood within 30 days Has any significant medical condition (including current or past history of cardiovascular disease), laboratory findings, or medical history that in the Investigator's opinion may affect successful completion of the study and/or personal well-being Is an immediate family member (spouse, parent, child, or sibling) of personnel directly affiliated with the study at the investigative site, or is personally directly affiliated with the study at the investigative site

Ages Eligible for Study
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Minimum Age: 18 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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Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: PaQ® Insulin Delivery Device|PaQ is a 3 day insulin delivery device. Utilizes 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.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in glycosylated hemoglobin A1C (HbA1c) (obtained from venous blood) from baseline at Week 12 |  | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in A1C from baseline at Week 8 |  | 8 weeks | 
| Change in fasting plasma glucose from baseline at end of study week 12 |  | 12 weeks | 
| Change in 7-point blood glucose profiles and 1.5-2 hour postprandial blood glucose excursions (average and by meal) from baseline at week 12 |  | 12 weeks | 
| Change in insulin dose (total, basal, and bolus) from Baseline at week 12 |  | 12 weeks | 
| Change in body weight from baseline at Week 12 |  | 12 weeks | 
| Occurrence of hypoglycemia, adverse events, and/or dermal irritation at PaQ application site |  | Throughout the study | 
| Change in measures of PROs from baseline at Week 12 |  | 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Diabetes Mellitus, Diabetes Mellitus, Type 2, Glucose Metabolism Disorders, Metabolic Diseases, Endocrine System Diseases, Insulin, Continuous subcutaneous insulin infusion (CSII), Insulin pumps