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.
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 Type
INTERVENTIONAL
Allocation
NA
Purpose
DEVICE_FEASIBILITY
Masking
NONE
Enrollment
1
Automated insulin delivery system comprising continuous glucose sensor (Dexcom G6), controller (InControl embedded in smartphone app) and insulin pump (YpsoMed Ypsopump)
Imperial College London, Imperial College Healthcare NHS Trust
London, United Kingdom
% time spent in target glucose range measured by continuous glucose monitoring (3.9-10mmol/L, 70-180mg/dL)
Consensus measure of time in range
Time frame: Extracted from the final 28 days of the intervention period
% time spent in hypoglycaemia (<3.0mmol/L, 54mg/dL)
Consensus measure of time in range
Time frame: 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
Time frame: 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
Time frame: Extracted from the final 28 days of the intervention period
% time spent in hyperglycaemia (>10mmol/L, 180mg/dL)
Consensus measure of time in range
Time frame: 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
Time frame: Over 12 week intervention period
Nocturnal Severe hypoglycaemia (defined as requiring third party assistance)
Consensus measure of exposure to hypoglycaemia
Time frame: Over 12 week intervention period
Severe hypoglycaemia (defined as requiring third party assistance)
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Consensus measure of exposure to hypoglycaemia
Time frame: Over 12 week intervention period
Glucose variability assessed by %Coefficient of Variation (%CV)
Consensus measure of glucose variability
Time frame: Extracted from the final 28 days of the intervention period
Glucose variability assessed by Mean Absolute Glucose (MAG)
Consensus measure of glucose variability
Time frame: Extracted from the final 28 days of the intervention period
Glucose variability assessed by Low Blood Glucose Index (LBGI)
Consensus measure of glucose variability
Time frame: Extracted from the final 28 days of the intervention period
HbA1c
Laboratory HbA1c assessment
Time frame: At end of 12 week intervention period
Time spent in automated insulin delivery mode
% of total time that automated insulin delivery is active
Time frame: Over 12 week intervention period
Treatment satisfaction (DTSQ, AP acceptability)
Validated patient reported outcome
Time frame: 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)
Time frame: 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
Time frame: At end of 12 week intervention period
Diabetes distress (PAID)
Validated patient reported outcome, Problem Areas In Diabetes 20 item
Time frame: At end of 12 week intervention period
Change in total daily insulin dose (units)
Total insulin delivered by system per day
Time frame: At end of 12 week intervention period
Change in weight (kg)
Weight in kg
Time frame: At end of 12 week intervention period