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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PaQ® Insulin Delivery Device | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PaQ® Insulin Delivery Device | Device | PaQ is a 3 day insulin delivery device which delivers 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Glycosylated hemoglobin A1C (HbA1c) (obtained from venous blood) | Change from Baseline at 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Glycosylated hemoglobin A1C (HbA1c) (obtained from venous blood) | Change from Baseline at 8 weeks | |
| Fasting plasma glucose | Change from Baseline at 12 weeks | |
| 7-point blood glucose profiles |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Thomas Pieber, MD | Medical University of Graz | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical University of Graz | Graz | A-8036 | Austria |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29888811 | Derived | 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. |
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No plan to share individual data sets, but will publish the results.
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D007333 | Insulin Resistance |
| ID | Term |
|---|---|
| D009750 | Nutritional and Metabolic Diseases |
| D006946 | Hyperinsulinism |
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| ID | Term |
|---|---|
| D061267 | Insulin Aspart |
| ID | Term |
|---|---|
| D061266 | Insulin, Short-Acting |
| D061385 | Insulins |
| D010187 | Pancreatic Hormones |
| D036361 | Peptide Hormones |
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| Insulin, Asp(B28)- | Drug | a fast-acting analog of human insulin |
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| Change from Baseline at 12 weeks |
| Total daily dose of insulin | Change from Baseline at 12 weeks |
| Body weight | Change from Baseline at 12 weeks |
| Barriers to Insulin Treatment questionnaire | Measures aspects of psychological obstacles to insulin treatment in people with type 2 diabetes. | Change from Baseline at 12 weeks |
| Diabetes Treatment Satisfaction Questionnaire | Designed to make the initial assessment of total diabetes treatment satisfaction, treatment satisfaction in specific areas, and perceived frequencies of hyperglycemia and hypoglycemia. | Change from Baseline at 12 weeks |
| Short form 36 Health Survey | It is a generic measure, as opposed to disease specific, which assesses the relative burden of diseases, and differentiates the health benefits produced by a wide range of different treatments. | Change from Baseline at 12 weeks |
| Adverse events | Collected throughout the study, average 14 weeks |
| Hypoglycemic events | Collected at baseline (on current insulin therapy) and throughout the study, average 14 weeks |
| D006728 |
| Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |