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Terminated to allow continued optimization of the product.
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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, 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.
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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. 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in glycosylated hemoglobin A1C (HbA1c) (obtained from venous blood) from baseline at Week 12 | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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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.
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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 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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| 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 |
| Occurrence of hypoglycemia, adverse events, and/or dermal irritation at PaQ application site | Throughout the study |
| Change in measures of PROs from baseline at Week 12 | 12 weeks |