An interventional study of Hybrid Automated Insulin Delivery in Gastroparesis and Type 1 Diabetes, sponsored by Imperial College London. Status unknown at 1 site in United Kingdom. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-09-13.
Sponsored by Imperial College London · Not applicable, Interventional, and Treatment
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.
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.
311 studies on the registry are indexed under Gastroparesis; 67 are open to participants now.
This study's planned enrollment of 16 is below the median of 42 across 205 interventional studies indexed under Gastroparesis.
Browse Gastroparesis studies →Imperial College London is the lead sponsor of 842 studies on the registry; 180 are open to participants now.
Of its 9 completed or terminated interventional studies of FDA-regulated products, 6 (67%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
The intervention is the Medtronic 780G Hybrid Automated Insulin Delivery system
Device: Hybrid Automated Insulin Delivery
The control is Standard Care with real-time CGM
Consists of an insulin pump and real-time continuous glucose monitoring (CGM)
Also known as: Medtronic 780G
Percentage time spent in glucose target (3.9-10mmol/L)
The change in percentage time in glucose target between baseline and intervention/control
Time frame: 4 - 8 weeks
Percentage time spent in hypoglycaemia (<3.0mmol/L)
The change in percentage time in hypoglycaemia(\<3.0mmol/L) between baseline and intervention/control
Time frame: 4 - 8 weeks
Percentage time spent in hypoglycaemia (<3.9mmol/L)
The change in percentage time in hypoglycaemia (\<3.9mmol/L) between baseline and intervention/control
Time frame: 4 - 8 weeks
Percentage time spent in hyperglycaemia (>10mmol/L)
The change in percentage time in hyperglycaemia (\>10mmol/L) between baseline and intervention/control
Time frame: 4 - 8 weeks
Plan to share: No
No publications or documents are linked to this record.
Started Aug 2023 (actual). Primary completion is estimated for Jun 2024, 10 months after the start.
Of 49 non-industry interventional studies with no phase under Gastroparesis, half reached primary completion within 36 months of starting (the median), counting those still running; a quarter within 14 and three quarters within 59. This study's planned 10 months is below that.
Counting every sponsor, half of 58 studies reached it within 25 months; a quarter within 11 and three quarters within 58.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Sep 2023. You cannot join it, but the record below documents what was studied.
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