Automated Insulin Delivery in Type 1 Diabetes Complicated by Gastroparesis

Trial ID: NCT05795309

Interventional - Phase Unknown - Unknown status

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.

Conditions

• Gastroparesis
• Type 1 Diabetes

Interventions

• Hybrid Automated Insulin Delivery

Eligibility

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

Sponsor

Imperial College London

Source: ClinicalTrials.gov

Search more clinical trials on myTomorrows