Gastroparesis, Type 1 Diabetes
Conditions
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.
Interventions
DEVICEHybrid Automated Insulin Delivery
Consists of an insulin pump and real-time continuous glucose monitoring (CGM)
Sponsors
Imperial College London
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Staggered randomised control trial
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 hyperglycaemia (>10mmol/L) | 4 - 8 weeks | The change in percentage time in hyperglycaemia (\>10mmol/L) between baseline and intervention/control |
Countries
United Kingdom
Contacts
Primary ContactMonika Reddy, PhD
Backup ContactNick Oliver, FRCP
Outcome results
None listed