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

Type 2 Diabetes Mellitus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01535612
• Other study ID #: CQR-09001
• Status: Completed
• Phase: N/A
• First received: September 2, 2011
• Last updated: July 25, 2016
• Start date: March 2012
• Est. completion date: September 2012

Study information

• Verified date: July 2016
• Source: CeQur Corporation
• Contact: n/a
• Is FDA regulated: No
• Health authority: Austria: Ethikkommission
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: September 2012
• Est. primary completion date: August 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 30 Years to 65 Years

Eligibility

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 Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes Mellitus

Intervention

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.

Locations

Country	Name	City	State
Austria	Medical University of Graz	Graz

Sponsors (2)

Lead Sponsor	Collaborator
CeQur Corporation	International Diabetes Center at Park Nicollet

Country where clinical trial is conducted

Austria, 

References & Publications (1)

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 2 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patients ability to successfully assemble, fill, prime, apply and use the PaQ™ device		End of two week transition period	Yes
Secondary	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	Yes
Secondary	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)	Yes
Secondary	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	Yes
Secondary	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	Yes
Secondary	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	Yes
Secondary	Infection at cannula insertion site		During transition and PaQ™ treatment period	Yes
Secondary	Occurence of adverse experiences and the number and severity of hypoglycemic episodes		During baseline, transition and PaQ™ treatment period	Yes
Secondary	Quality of Life Questionnaire		At the end of the study	No
Secondary	Dermal Irritation		During transition and PaQ™ treatment period	Yes