Feasibility of Automated Insulin Delivery With an Interoperable Algorithm Using an Alternative Insulin Pump

Study Overview
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Brief Summary
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This clinical study assesses the feasibility of implementing the inControl automated insulin delivery algorithm with Dexcom continuous glucose monitoring and a compatible insulin pump in adults with type 1 diabetes. It additionally provides pilot efficacy outcomes for interoperable automated insulin delivery.

Detailed Description
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Self-management of type 1 diabetes is challenging, efforts to optimise time spent in the target range can result in hypo- and hyperglycaemia. Structured education, glucose monitoring and advances in insulin delivery can increase time in range and reduce exposure to extremes of glucose and recent data confirm that automated insulin delivery can enable further increases in time spent in the target range of 3.9 to 10mmol/L (70 - 180mg/dL). The inControl algorithm, developed by TypeZero technologies is embedded in the Tandem X2 insulin pump and operates with the Dexcom G6 continuous glucose sensor and transmitter in a CE-marked and commercially available system (known as Control-IQ). This system optimises time in range compared with sensor-augmented pump therapy, and the improvement was maintained when participants were further randomised to predictive low glucose suspend or automated insulin delivery. The United States Food and Drug Administration has defined interoperable standards for automated insulin delivery systems, including the iCGM designation for continuous glucose sensors, the interoperable automated glycaemic controller designation, and alternate controller enabled insulin pumps. However, while standards have been defined, to date, interoperability of automated insulin delivery components has not been demonstrated.

Official Title
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Feasibility of Automated Insulin Delivery With an Interoperable Algorithm Using an Alternative Insulin Pump

Conditions
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Type 1 Diabetes

Intervention / Treatment
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* Device: InControl


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) Exclusion Criteria: Total daily insulin dose greater than 100 units Weight greater than 140kg 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: Device Feasibility
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Automated Insulin Delivery<br>The components of the automated insulin delivery system are the Dexcom G6 continuous glucose monitor (CGM), the InControl algorithm and an insulin pump (Ypsomed Ypsopump). The Dexcom G6 continuous glucose monitoring device is an approved device and is licensed to be used to inform insulin dosing decisions without confirmation. The algorithm (inControl 1.0) is approved when used embedded in the Tandem X2 insulin pump. We are using the algorithm for its intended purpose but are implementing it in a smartphone app to be installed in a compatible smartphone (Android). We are additionally assessing incremental benefit with the next software version of the algorithm. This will be the first time this updated software has been assessed in people with type 1 diabetes. The compatible insulin pump is a continuous subcutaneous insulin infusion device and is being used in line with its intended purpose, according to the manufacturer's instructions (YpsoMed Ypsopump). | Device: InControl<br>* Automated insulin delivery system comprising continuous glucose sensor (Dexcom G6), controller (InControl embedded in smartphone app) and insulin pump (YpsoMed Ypsopump)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| % time spent in target glucose range measured by continuous glucose monitoring (3.9-10mmol/L, 70-180mg/dL) | Consensus measure of time in range | Extracted from the final 28 days of the intervention period | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| % time spent in hypoglycaemia (<3.0mmol/L, 54mg/dL) | Consensus measure of time in range | Extracted from the final 28 days of the intervention period | 
| % time spent in hypoglycaemia (<3.9mmol/L, 70mg/dL) | Consensus measure of time in range | Extracted from the final 28 days of the intervention period | 
| % time in euglycaemia (3.9-7.8mmol/L, 70-140mg/dL) | Consensus measure of time in range | Extracted from the final 28 days of the intervention period | 
| % time spent in hyperglycaemia (>10mmol/L, 180mg/dL) | Consensus measure of time in range | Extracted from the final 28 days of the intervention period | 
| Number hypoglycaemic excursions (sensor glucose <3.0mmol/l for >= 20min) | Consensus measure of exposure to hypoglycaemia | Over 12 week intervention period | 
| Nocturnal Severe hypoglycaemia (defined as requiring third party assistance) | Consensus measure of exposure to hypoglycaemia | Over 12 week intervention period | 
| Severe hypoglycaemia (defined as requiring third party assistance) | Consensus measure of exposure to hypoglycaemia | Over 12 week intervention period | 
| Glucose variability assessed by %Coefficient of Variation (%CV) | Consensus measure of glucose variability | Extracted from the final 28 days of the intervention period | 
| Glucose variability assessed by Mean Absolute Glucose (MAG) | Consensus measure of glucose variability | Extracted from the final 28 days of the intervention period | 
| Glucose variability assessed by Low Blood Glucose Index (LBGI) | Consensus measure of glucose variability | Extracted from the final 28 days of the intervention period | 
| HbA1c | Laboratory HbA1c assessment | At end of 12 week intervention period | 
| Time spent in automated insulin delivery mode | % of total time that automated insulin delivery is active | Over 12 week intervention period | 
| Treatment satisfaction (DTSQ, AP acceptability) | Validated patient reported outcome | At end of 12 week intervention period | 
| Gold score | Validated patient reported outcome of hypoglycaemia awareness (1-7, with greater value indicating loss of awareness) | At end of 12 week intervention period | 
| Diabetes distress (DDS-17) | Validated patient reported outcome, Diabetes Distress Score 17 item, higher scores mean greater distress | At end of 12 week intervention period | 
| Diabetes distress (PAID) | Validated patient reported outcome, Problem Areas In Diabetes 20 item | At end of 12 week intervention period | 
| Change in total daily insulin dose (units) | Total insulin delivered by system per day | At end of 12 week intervention period | 
| Change in weight (kg) | Weight in kg | At end of 12 week intervention period | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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automated insulin delivery