A Prospective, Single Center, Observational Study to Assess the Performance, Safety, and Patient Reported Outcomes of Insulin Delivery with PaQ® in Patients with Type 2 Diabetes Mellitus

CeQur Corp.0 sitesDecember 22, 2014

Overview

No summary available.

Registry

who.int

Start Date

December 22, 2014

End Date

TBD

Last Updated

9 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

CeQur Corp.

•1\.Is at least 18 years of age;
•2\.Has a clinical diagnosis of T2DM, as determined by clinical history and medication usage;
•3\.Has an A1C \= 7\.0% and ? 11\.0%;
•4\.Is treated with basal\-bolus insulin therapy (at least 2 injections per day) with or without OADs, and/or 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, (See Section 7\.4 for definition of baseline basal bolus therapy);
•5\.Determined by the investigator that insulin requirements to achieve glycemic targets can be met by the insulin capacity of the PaQ device;
•6\.If on concomitant metformin, has serum creatinine \<1\.5 mg/dL (male) or \<1\.4 mg/dL (female);
•7\.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;
•8\.Is clinically euthyroid as judged by the Investigator;
•9\.Is able to understand and sign the required study documents and comply with the CIP requirements;
•10\.Is deemed capable by the Investigator to perform the requirements of the CIP, including use of PaQ, frequent self\-monitoring of blood glucose.

•1\.Is poorly compliant with the currently prescribed diabetes regimen, as determined by the Investigator;
•2\.Is poorly compliant with prescribed self\-monitoring of blood glucose, as determined by the Investigator;
•3\.Is currently taking or has taken sulfonylureas within the last 2 months;
•4\.Has a BMI greater than 40 kg/m2;
•5\.Has experienced recurrent severe hypoglycemia (\> 2 episodes) requiring assistance during the past 6 months;
•6\.Has existing dermal irritation/inflammation over the abdominal area that may interfere with use of PaQ, as determined by the Investigator;
•7\.Has known clinically significant hypersensitivity to skin adhesives;
•8\.Is female and if of child\-bearing potential, is pregnant, lactating, or planning to become pregnant;
•9\.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);
•10\.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;