Automated Insulin Delivery in Type 1 Diabetes Complicated by Gastroparesis

Study Overview
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Brief Summary
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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
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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.

Official Title
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Automated Insulin Delivery in Type 1 Diabetes Complicated by Gastroparesis

Conditions
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Type 1 Diabetes, Gastroparesis

Intervention / Treatment
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* Device: Hybrid Automated Insulin Delivery


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Sequential Assignment
Interventional Model Description: Staggered randomised control trial
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Hybrid Automated Insulin Delivery<br>The intervention is the Medtronic 780G Hybrid Automated Insulin Delivery system | Device: Hybrid Automated Insulin Delivery<br>* Consists of an insulin pump and real-time continuous glucose monitoring (CGM)<br>* Other names: Medtronic 780G;|
| No Intervention: Standard care<br>The control is Standard Care with real-time CGM | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage time spent in hypoglycaemia (<3.0mmol/L) | The change in percentage time in hypoglycaemia(<3.0mmol/L) between baseline and intervention/control | 4 - 8 weeks | 
| Percentage time spent in hypoglycaemia (<3.9mmol/L) | The change in percentage time in hypoglycaemia (<3.9mmol/L) between baseline and intervention/control | 4 - 8 weeks | 
| Percentage time spent in hyperglycaemia (>10mmol/L) | The change in percentage time in hyperglycaemia (>10mmol/L) between baseline and intervention/control | 4 - 8 weeks |