Automated insulin delivery for type 1 diabetes with gastroparesis
Automated Insulin Delivery in Type 1 Diabetes Complicated by Gastroparesis
This study is testing a new automated insulin delivery system to see if it can help people with type 1 diabetes and stomach issues manage their blood sugar and improve their digestive symptoms.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 16 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Imperial College London Academic / other |
| Locations | 1 site (London) |
| Trial ID | NCT05795309 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the effectiveness of a hybrid automated insulin delivery (AID) system in managing glucose levels and gastrointestinal symptoms in patients with type 1 diabetes complicated by gastroparesis. Participants will undergo a 2-week run-in period before being randomized to either a control group or the AID intervention using the 780G system for a total of 12 weeks. The study includes a combination of face-to-face and remote visits, as well as telephone consultations, to monitor outcomes and ensure participant engagement throughout the trial. The primary focus is on assessing improvements in glucose control and patient-reported outcomes related to gastrointestinal function.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with type 1 diabetes for over a year and experiencing symptoms of gastroparesis.
Not a fit: Patients who are currently using an automated insulin delivery system or have severe renal impairment may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve glucose management and quality of life for patients with type 1 diabetes and gastroparesis.
How similar studies have performed: While automated insulin delivery systems have shown promise in other studies, this specific application for patients with gastroparesis is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
London
- Imperial College London and Imperial College Healthcare NHS Trust — London, United Kingdom (Recruiting)
Study contacts
- Principal investigator: Nick Oliver — Imperial College London
- Study coordinator: Monika Reddy, PhD
- Email: m.reddy@imperial.ac.uk
- Phone: +44 (0)20 7594 1796
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.