NCT05795309

Automated Insulin Delivery in Type 1 Diabetes Complicated by Gastroparesis

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 16 (estimated)
• Sponsor: Imperial College London · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a staggered randomised controlled trial that aims to assess the impact of an automated insulin delivery (AID) system on glucose, gastrointestinal and patient-reported outcomes.

Detailed description

Following a run-in period of 2 weeks, participants will be randomised to control or hybrid automated insulin delivery (AID) using the 780G system and will remain in the intervention phase of the study for 12 weeks (4-week control, then 4-week AID or Control and finally 4-week AID). The total duration for each participant will be 14 weeks. There are 5 study visits (combination of face to face or/and remote) and two telephone visits in total.

Conditions

• Gastroparesis
• Type 1 Diabetes

Interventions

Type	Name	Description
DEVICE	Hybrid Automated Insulin Delivery	Consists of an insulin pump and real-time continuous glucose monitoring (CGM)

Timeline

• Start date: 2023-08-16
• Primary completion: 2024-06-30
• Completion: 2024-06-30
• First posted: 2023-04-03
• Last updated: 2023-09-13

Locations

1 site across 1 country: United Kingdom