A Prospective, Single Center Study to Assess the Performance, Safety, and Patient Reported Outcomes of Insulin Delivery With PaQ® in Patients With Type 2 Diabetes Mellitus
Overview
- Phase
- N/A
- Intervention
- PaQ® Insulin Delivery Device
- Conditions
- Type 2 Diabetes Mellitus
- Sponsor
- CeQur Corporation
- Enrollment
- 20
- Locations
- 1
- Primary Endpoint
- Glycosylated hemoglobin A1C (HbA1c) (obtained from venous blood)
- Status
- Completed
- Last Updated
- 9 years ago
Overview
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, open-label, uncontrolled 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.
Investigators
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 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, (See Section 7.4 for definition of baseline basal bolus therapy);
- •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 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;
Arms & Interventions
PaQ® Insulin Delivery Device
The intervention is continuous subcutaneous U 100 Insulin, Asp(B28)-rapid-acting insulin, at a constant basal rate of either 20, 24, 32, 40 or 50 U per day over 3 days and and bolus insulin as needed at meals in 2 U increments.
Intervention: PaQ® Insulin Delivery Device
PaQ® Insulin Delivery Device
The intervention is continuous subcutaneous U 100 Insulin, Asp(B28)-rapid-acting insulin, at a constant basal rate of either 20, 24, 32, 40 or 50 U per day over 3 days and and bolus insulin as needed at meals in 2 U increments.
Intervention: Insulin, Asp(B28)-
Outcomes
Primary Outcomes
Glycosylated hemoglobin A1C (HbA1c) (obtained from venous blood)
Time Frame: Change from Baseline at 12 weeks
Secondary Outcomes
- Fasting plasma glucose(Change from Baseline at 12 weeks)
- 7-point blood glucose profiles(Change from Baseline at 12 weeks)
- Glycosylated hemoglobin A1C (HbA1c) (obtained from venous blood)(Change from Baseline at 8 weeks)
- Body weight(Change from Baseline at 12 weeks)
- Barriers to Insulin Treatment questionnaire(Change from Baseline at 12 weeks)
- Adverse events(Collected throughout the study, average 14 weeks)
- Total daily dose of insulin(Change from Baseline at 12 weeks)
- Hypoglycemic events(Collected at baseline (on current insulin therapy) and throughout the study, average 14 weeks)
- Diabetes Treatment Satisfaction Questionnaire(Change from Baseline at 12 weeks)
- Short form 36 Health Survey(Change from Baseline at 12 weeks)