Feasibility of Automated Insulin Delivery With an Interoperable Algorithm Using an Alternative Insulin Pump
Trial Snapshot
- Phase
- Not Applicable
- Status
- Terminated
- Sponsor
- Imperial College London
- Enrollment
- 1
- Locations
- 1
- Primary Endpoint
- % time spent in target glucose range measured by continuous glucose monitoring (3.9-10mmol/L, 70-180mg/dL)
Study Overview
Brief Summary
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
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Device Feasibility
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts 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)
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
Arms & Interventions
Automated Insulin Delivery
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).
Intervention: InControl (Device)
Outcomes
Primary Outcomes
% time spent in target glucose range measured by continuous glucose monitoring (3.9-10mmol/L, 70-180mg/dL)
Time Frame: Extracted from the final 28 days of the intervention period
Consensus measure of time in range
Secondary Outcomes
- Nocturnal Severe hypoglycaemia (defined as requiring third party assistance)(Over 12 week intervention period)
- Treatment satisfaction (DTSQ, AP acceptability)(At end of 12 week intervention period)
- Gold score(At end of 12 week intervention period)
- % time spent in hypoglycaemia (<3.0mmol/L, 54mg/dL)(Extracted from the final 28 days of the intervention period)
- Glucose variability assessed by %Coefficient of Variation (%CV)(Extracted from the final 28 days of the intervention period)
- HbA1c(At end of 12 week intervention period)
- Change in total daily insulin dose (units)(At end of 12 week intervention period)
- % time in euglycaemia (3.9-7.8mmol/L, 70-140mg/dL)(Extracted from the final 28 days of the intervention period)
- Number hypoglycaemic excursions (sensor glucose <3.0mmol/l for >= 20min)(Over 12 week intervention period)
- Glucose variability assessed by Low Blood Glucose Index (LBGI)(Extracted from the final 28 days of the intervention period)
- Time spent in automated insulin delivery mode(Over 12 week intervention period)
- % time spent in hypoglycaemia (<3.9mmol/L, 70mg/dL)(Extracted from the final 28 days of the intervention period)
- % time spent in hyperglycaemia (>10mmol/L, 180mg/dL)(Extracted from the final 28 days of the intervention period)
- Severe hypoglycaemia (defined as requiring third party assistance)(Over 12 week intervention period)
- Glucose variability assessed by Mean Absolute Glucose (MAG)(Extracted from the final 28 days of the intervention period)
- Diabetes distress (PAID)(At end of 12 week intervention period)
- Change in weight (kg)(At end of 12 week intervention period)
- Diabetes distress (DDS-17)(At end of 12 week intervention period)