Clinical trial NCT02158078: A Prospective Observational Study to Assess Insulin Delivery With PaQ® in Patients With Type 2 Diabetes Mellitus
Official title: A Prospective, Single Center, Post-Market Observational Study to Assess the Efficacy, Safety, and Patient Reported Outcomes of Insulin Delivery With PaQ® in Patients With Type 2 Diabetes Mellitus
Study type: OBSERVATIONAL
Overall status: TERMINATED
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
Lead sponsor: CeQur Corporation
Sponsor class: INDUSTRY
First posted: 2014-06-06
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
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.

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).

Detailed description: This is a prospective, single center, post-market observational study to assess the efficacy, safety, and patient reported outcomes of insulin delivery with PaQ® in patients with type 2 diabetes mellitus (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 three phases: screening/baseline evaluation, transition to PaQ use and optimization, 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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Change in glycosylated hemoglobin A1C (HbA1c) (obtained from venous blood) from baseline at Week 12
timeFrame: 12 weeks
Secondary outcomes:
measure: Change in A1C from baseline at Week 8
timeFrame: 8 weeks
measure: Change in fasting plasma glucose from baseline at end of study week 12
timeFrame: 12 weeks
measure: 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
timeFrame: 12 weeks
measure: Change in insulin dose (total, basal, and bolus) from Baseline at week 12
timeFrame: 12 weeks
measure: Change in body weight from baseline at Week 12
timeFrame: 12 weeks
measure: Occurrence of hypoglycemia, adverse events, and/or dermal irritation at PaQ application site
timeFrame: Throughout the study
measure: Change in measures of PROs from baseline at Week 12
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Graz
country: Austria
facility: Medical University of Graz
Study officials:
affiliation: Medical University of Graz
name: Thomas Pieber, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.