Automated Insulin Delivery in Type 1 Diabetes Complicated by Gastroparesis (AIDgastro)

Imperial College London

Status

Enrolling

Conditions

Type 1 Diabetes

Gastroparesis

Treatments

Device: Hybrid Automated Insulin Delivery

Study type

Interventional

Funder types

Other

Identifiers

NCT05795309

22HH8008

Details and patient eligibility

About

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.

Full 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.

Enrollment

16 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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