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

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

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.

Study Overview

• Status: Completed
• Conditions: Type 2 Diabetes Mellitus
• Intervention / Treatment: Device: PaQ™ insulin infusion device

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Austria
  • Graz, Austria, A-8036
    • Medical University of Graz

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Male/female patient's ≥ 30 ≤ 65 years of age.
2. Clinical confirmation of T2DM diagnosis by history and medication usage or glucose tolerance test.
3. Currently treated with insulin using a basal/bolus regimen with or without concurrent use of OADs (metformin and/or glitazone).
4. 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.
5. Currently uses between 20 to 50 units/day basal insulin.

Exclusion Criteria:

1. Uncontrolled hyperglycemia, HbA1c > 9.0% requiring adjustment to his/her insulin regimen.
2. Treated with premixed insulin, or neutral protamine hagedorn (NPH)/glargine/detemir insulin without use of bolus/meal time insulin.
3. Patient has had an episode of severe (assisted) hypoglycemia within the past 30 days.
4. Currently treated with sulfonylurea or incretin-based therapy [glucagon-like peptide-1(GLP-1) agonist or dipeptidyl peptidase-4 (DPP-4) inhibitor].
5. Total daily dose (TDD) of insulin is >100 units/day.
6. Have a meal-time bolus doses that exceeds the capacity of the bolus Insulin Reservoir at any given meal.
7. Have existing dermal irritation on their abdomen or have known hypersensitivity to skin adhesives.
8. Taking or has taken prednisone or cortisone medications in the previous 30 days.
9. Pregnant or is planning to become pregnant during the study period.
10. 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.
11. Unable to follow the study clinical investigational plan (CIP)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: PaQ™ insulin infusion device; PaQ™ insulin infusion device which delivers rapid acting insulin.	Device: PaQ™ insulin infusion device; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: CeQur Corporation
• Collaborators: International Diabetes Center at Park Nicollet

Publications and helpful links

General Publications

• Mader JK, Lilly LC, Aberer F, Korsatko S, Strock E, Mazze RS, Damsbo P, Pieber TR. A feasibility study of a 3-day basal-bolus insulin delivery device in individuals with type 2 diabetes. Diabetes Care. 2014 May;37(5):1476-9. doi: 10.2337/dc13-2238. Epub 2014 Mar 5.

Study record dates

Study Major Dates

• Study Start: March 1, 2012
• Primary Completion (Actual): August 1, 2012
• Study Completion (Actual): September 1, 2012

Study Registration Dates

• First Submitted: September 2, 2011
• First Submitted That Met QC Criteria: February 17, 2012
• First Posted (Estimate): February 20, 2012

Study Record Updates

• Last Update Posted (Estimate): July 27, 2016
• Last Update Submitted That Met QC Criteria: July 25, 2016
• Last Verified: July 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2; Hypoglycemic Agents; Physiological Effects of Drugs; Insulin
• Other Study ID Numbers: CQR-09001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Published in Diabetes Care - Volume 37, May 2014, pages 1476-1479