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

NCT ID: NCT01535612

Last Updated: 2016-07-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-03-31
• Study Completion Date: 2012-09-30

Brief 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.

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.

Conditions

Type 2 Diabetes Mellitus

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

PaQ™ insulin infusion device

PaQ™ insulin infusion device which delivers rapid acting insulin.

Group Type: EXPERIMENTAL

PaQ™ insulin infusion device

Intervention Type: 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.

Interventions

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.

Intervention Type: DEVICE

Eligibility Criteria

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)

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

International Diabetes Center at Park Nicollet

OTHER

Sponsor Role: collaborator

CeQur Corporation

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Thomas Pieber, MD

Role: PRINCIPAL_INVESTIGATOR

Medical University of Graz

Locations

Medical University of Graz

Graz, , Austria

Countries

Austria

References

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.

Reference Type: RESULT

PMID: 24598242 (View on PubMed)

Other Identifiers

CQR-09001

Identifier Type: -

Identifier Source: org_study_id