Automated Insulin Delivery in Type 1 Diabetes Complicated by Gastroparesis
AIDgastro
1 other identifier
interventional
16
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Aug 2023
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 21, 2023
CompletedFirst Posted
Study publicly available on registry
April 3, 2023
CompletedStudy Start
First participant enrolled
August 16, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2024
CompletedSeptember 13, 2023
September 1, 2023
11 months
March 21, 2023
September 8, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
Percentage time spent in glucose target (3.9-10mmol/L)
The change in percentage time in glucose target between baseline and intervention/control
4 - 8 weeks
Secondary Outcomes (3)
Percentage time spent in hypoglycaemia (<3.0mmol/L)
4 - 8 weeks
Percentage time spent in hypoglycaemia (<3.9mmol/L)
4 - 8 weeks
Percentage time spent in hyperglycaemia (>10mmol/L)
4 - 8 weeks
Study Arms (2)
Hybrid Automated Insulin Delivery
EXPERIMENTALThe intervention is the Medtronic 780G Hybrid Automated Insulin Delivery system
Standard care
NO INTERVENTIONThe control is Standard Care with real-time CGM
Interventions
Consists of an insulin pump and real-time continuous glucose monitoring (CGM)
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Imperial College London and Imperial College Healthcare NHS Trust
London, W12 0HS, United Kingdom
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Nick Oliver
Imperial College London
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 21, 2023
First Posted
April 3, 2023
Study Start
August 16, 2023
Primary Completion
June 30, 2024
Study Completion
June 30, 2024
Last Updated
September 13, 2023
Record last verified: 2023-09
Data Sharing
- IPD Sharing
- Will not share