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

NCT01535612 | Completed

• 1 other identifier: CQR-09001
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Type 2 Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

• Patients ability to successfully assemble, fill, prime, apply and use the PaQ™ device

  End of two week transition period

Secondary Outcomes (9)

• Insulin usage

  End of two baseline period and end of 2 week treatment period

• 7-point blood glucose reading

  Twice per week during baseline period (weeks 1 & 2) and PaQ™ Treatment period (weeks 5 & 6)

• Glucose variability

  During baseline and PaQ™ treatment period

• Glucose exposure

  During baseline and PaQ™ treatment period

• Glucose Stability

  During baseline and PaQ™ Treatment Period

Study Arms (1)

PaQ™ insulin infusion device

EXPERIMENTAL

PaQ™ insulin infusion device which delivers rapid acting insulin.

Device: PaQ™ insulin infusion device

Interventions

PaQ™ insulin infusion device 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.

PaQ™ insulin infusion device

Eligibility Criteria

• Age: 30 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• CeQur Corporation: lead
• International Diabetes Center at Park Nicollet: collaborator

Study Sites (1)

Medical University of Graz

Graz, A-8036, Austria

Location

Related 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 2014 Mar 5.

  PMID: 24598242 RESULT

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Thomas Pieber, MD

  Medical University of Graz

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 2, 2011
• First Posted: February 20, 2012
• Study Start: March 1, 2012
• Primary Completion: August 1, 2012
• Study Completion: September 1, 2012
• Last Updated: July 27, 2016

Record last verified: 2016-07

Data Sharing

• IPD Sharing: Will share

Locations

AU (1)