A Prospective Observational Study to Assess Insulin Delivery With PaQ® in Patients With Type 2 Diabetes Mellitus

NCT02158078 | Terminated

• 1 other identifier: CQR13002
• Study Type: observational
• Target: 8
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of the study is to obtain an assessment (efficacy, safety, and patient reported outcomes) of basal bolus insulin delivery with PaQ in insulin-using patients with type 2 diabetes mellitus (T2DM).

Conditions

Type 2 Diabetes Mellitus

Keywords

Diabetes Mellitus; Diabetes Mellitus, Type 2; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Insulin; Continuous subcutaneous insulin infusion (CSII); Insulin pumps

Outcome Measures

Primary Outcomes (1)

• Change in glycosylated hemoglobin A1C (HbA1c) (obtained from venous blood) from baseline at Week 12

  12 weeks

Secondary Outcomes (7)

• Change in A1C from baseline at Week 8

  8 weeks

• Change in fasting plasma glucose from baseline at end of study week 12

  12 weeks

• Change in 7-point blood glucose profiles and 1.5-2 hour postprandial blood glucose excursions (average and by meal) from baseline at week 12

  12 weeks

• Change in insulin dose (total, basal, and bolus) from Baseline at week 12

  12 weeks

• Change in body weight from baseline at Week 12

  12 weeks

Interventions

PaQ® Insulin Delivery Device DEVICE

PaQ is a 3 day insulin delivery device. Utilizes U 100 rapid-acting insulin. Provides basal insulin at preset basal doses and bolus insulin (in 2 unit increments) with a push of a button.

Eligibility Criteria

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

Study Population

Twenty five (25) individuals with T2DM who have an A1C of 7.0% to 11.0%, inclusive, at Screening (Visit 1) will be recruited at one investigative site.

You may qualify if:

• Is at least 18 years of age
• Has a clinical diagnosis of T2DM, as determined by clinical history and medication usage
• Has an A1C ≥ 7.0% and ≤ 11.0%;
• Is treated with basal-bolus insulin therapy (at least 2 injections per day) with or without OADs, and/or glucagon-like peptide-1 (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
• Determined by the investigator that insulin requirements to achieve glycemic targets can be met by the insulin capacity of the PaQ device
• If on concomitant metformin, has serum creatinine \<1.5 mg/dL (male) or \<1.4 mg/dL (female)
• 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
• Is clinically euthyroid as judged by the Investigator
• Is able to understand and sign the required study documents and comply with the clinical investigational plan (CIP) requirements
• Is deemed capable by the Investigator to perform the requirements of the CIP, including use of PaQ, frequent self-monitoring of blood glucose

You may not qualify if:

• Is poorly compliant with the currently prescribed diabetes regimen, as determined by the Investigator
• Is poorly compliant with prescribed self-monitoring of blood glucose, as determined by the Investigator
• Is currently taking or has taken sulfonylureas within the last 2 months
• Has a BMI greater than 40 kg/m2
• Has experienced recurrent severe hypoglycemia (\> 2 episodes) requiring assistance during the past 6 months
• Has existing dermal irritation/inflammation over the abdominal area that may interfere with use of PaQ, as determined by the Investigator
• Has known clinically significant hypersensitivity to skin adhesives
• Is female and if of child-bearing potential, is pregnant, lactating, or planning to become pregnant
• 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)
• 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
• Has received any investigational drug within 1 month
• Has donated blood within 30 days
• Has any significant medical condition (including current or past history of cardiovascular disease), laboratory findings, or medical history that in the Investigator's opinion may affect successful completion of the study and/or personal well-being
• Is an immediate family member (spouse, parent, child, or sibling) of personnel directly affiliated with the study at the investigative site, or is personally directly affiliated with the study at the investigative site

Sponsors & Collaborators

• CeQur Corporation: lead

Study Sites (1)

Medical University of Graz

Graz, A-8036, Austria

Location

Related Publications (1)

• Mader JK, Lilly LC, Aberer F, Poettler T, Johns D, Trautmann M, Warner JL, Pieber TR. Improved glycaemic control and treatment satisfaction with a simple wearable 3-day insulin delivery device among people with Type 2 diabetes. Diabet Med. 2018 Oct;35(10):1448-1456. doi: 10.1111/dme.13708. Epub 2018 Jul 5.

  PMID: 29888811 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Insulin Resistance

Condition Hierarchy (Ancestors)

Nutritional and Metabolic Diseases; Hyperinsulinism

Study Officials

• Thomas Pieber, MD

  Medical University of Graz

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 4, 2014
• First Posted: June 6, 2014
• Study Start: June 1, 2014
• Primary Completion: November 1, 2014
• Study Completion: November 1, 2014
• Last Updated: July 26, 2016

Record last verified: 2016-07

Data Sharing

• IPD Sharing: Will share

Locations

AU (1)