Automated Insulin Delivery in Type 1 Diabetes Complicated by Gastroparesis

Not Applicable

Recruiting

• Conditions: Type 1 Diabetes; Gastroparesis
• Interventions: Device: Hybrid Automated Insulin Delivery

• Registration Number: NCT05795309
• Lead Sponsor: Imperial College London

Brief 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.

Study Timeline

• Study First Submitted: 2023-03-21
• Study First Submitted QC: 2023-03-21
• Study First Posted: 2023-04-03
• Study Start: 2023-08-16
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-08
• Last Update Posted: 2023-09-13
• Primary Completion: 2024-06-30
• Study Completion: 2024-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 16

Inclusion Criteria

• Aged 18 years of age or older
• Type 1 diabetes confirmed on the basis of clinical features
• Type 1 diabetes for greater than 1 year
• On an intensified insulin regimen with multiple dose injection or insulin pump for > 3 months
• HbA1c >7.5% (58mmol/mol) (or %TIR 3.9-10mmol/L <52% for participants already using a continuous glucose sensor)
• Gastroparesis Cardinal Symptom Index (GCSI) ≥ 18 or evidence of delayed gastric emptying on nuclear medicine gastric emptying study

Exclusion Criteria

• Enrolled in other clinical trials
• Estimated glomerular filtration rate of ≤30ml/min
• Pregnant or planning pregnancy
• Have active malignancy or under investigation for malignancy
• Severe visual impairment
• Reduced manual dexterity
• Use of any automated insulin delivery system
• Unable to participate due to other factors, as assessed by the Chief Investigator

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Hybrid Automated Insulin Delivery	Hybrid Automated Insulin Delivery	The intervention is the Medtronic 780G Hybrid Automated Insulin Delivery system

Primary Outcome Measures

Name	Time	Method
Percentage time spent in glucose target (3.9-10mmol/L)	4 - 8 weeks	The change in percentage time in glucose target between baseline and intervention/control

Secondary Outcome Measures

Name	Time	Method
Percentage time spent in hyperglycaemia (>10mmol/L)	4 - 8 weeks	The change in percentage time in hyperglycaemia (\>10mmol/L) between baseline and intervention/control
Percentage time spent in hypoglycaemia (<3.9mmol/L)	4 - 8 weeks	The change in percentage time in hypoglycaemia (\<3.9mmol/L) between baseline and intervention/control
Percentage time spent in hypoglycaemia (<3.0mmol/L)	4 - 8 weeks	The change in percentage time in hypoglycaemia(\<3.0mmol/L) between baseline and intervention/control

Trial Locations

Locations (1)

Imperial College London and Imperial College Healthcare NHS Trust; 🇬🇧 London, United Kingdom