CLAIMT2D
Study title
Assessing the impact of hybrid closed loop automated insulin therapy in the management of early onset type 2 diabetes
Funding and sponsorship
Medtronic Funded
Sponsored by the University of Leicester
Background
Automated insulin delivery use in T2D shows success in helping adults achieve their glycaemic targets safely; however, the evidence so far is in older individuals, with no specific data available demonstrating the efficacy and safety of AID use in those with EOT2D. Individuals in Leicester with EOT2D who are already on MDI insulin regimes would highly benefit from diabetes technologies, starting with smart insulin pens with CGM, and ultimately AHCL therapy, especially given the high-risk population we have in Leicester as described above. Taking this into consideration, as well as our dedicated research interest in EOT2D, Leicester is the ideal site for studying the efficacy and safety of AHCL therapy in those with EOT2D.
This project will therefore assess the acceptability, usability and clinical benefits of AHCL therapy in adults with EOT2D in Leicester. As previous studies looking at AID use have been relatively short in duration, we will be studying AHCL use for a longer duration of 24 weeks.
The primary objective of the study is to evaluate the efficacy on glycaemic control of the AHCL system versus standard MDI regime in adults with EOT2D at 12 weeks.
Study aims
Total duration: Approximately 28 weeks (4-week run-in period, followed by 24 weeks of treatment, with primary endpoint to be assessed at 12 weeks into treatment).
4-week run-in period for baseline data collection (no treatment change during this period, only to commence/switch over to Simplera continuous glucose monitoring (CGM) sensor for glucose data collection and InPenTM connected insulin pens to collect data on insulin administration). Randomisation to take place at the end of the run-in period to either:
Treatment Arm: Advanced Hybrid Closed Loop (AHCL) with the MiniMed™ 780G Insulin Pump for a study phase of 12 weeks followed by a continuation phase of a further 12 weeks
Control Arm: Continue standard treatment with MDI using InPenTM connected pens and Simplera CGM (for data collection, not utilising smart features) for a study phase of 12 weeks, followed by a delayed crossover to switch over to the AHCL for 12 weeks for the continuation phase
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