ASSIIST
Study title
Assessing the Impact of InPenTM Smart MDI System in Type 2 Diabetes
Funding and sponsorship
Medtronic Funded
Sponsored by the University of Leicester
Background
Establishing the optimal mealtime insulin dose in basal-bolus therapy may be difficult because it often involves calculations that consider multiple factors such as current blood glucose, target blood glucose, insulin-to-carbohydrate ratios, total carbohydrate content of meals, and activity levels.
Since the discovery of insulin in 1921, multiple advancements in insulin development and delivery have been made, including ultrarapid and ultra-long-acting insulins, insulin pens, and most recently, the introduction of connected (i.e., tracking and smart) insulin pens and caps. Data from smart insulin pens and connected devices are shining the spotlight on multiple daily injections (MDI) therapy, revealing both gaps and opportunities to significantly improve care for this population.
The aim of the study is to compare the efficacy of InPenTM Smart MDI System versus conventional MDI in improving glycaemic control (HbA1C) in patients with Type 2 Diabetes.
Study aims
This study is a randomised controlled trial. This includes participants adults >18 years inclusive who have been diagnosed with type 2 diabetes mellitus and are on multiple daily injections (>2 boluses daily). Approximately 78 MDI (Assuming 10% dropouts) with basal bolus regime (At least 2 boluses) will be enrolled to achieve approximately 62 subjects randomised (approximately 31 subjects on each arm). A 28 week study, to evaluate the efficacy of the InPen Smart MDI device on glycaemic control versus usual care in patients with Type 2 diabetes at 12 weeks.
Study summary
Study progress
In set up
Study publications
N/A
Data Protection
PI: Pratik Choudhary
Senior Trial Manager: Mahfuja Ahmed
For more information, please contact: T1andTechResearch@uhl-tr.nhs.uk