Clinical trial NCT05299177: Feasibility of Automated Insulin Delivery With an Interoperable Algorithm Using an Alternative Insulin Pump
Official title: Feasibility of Automated Insulin Delivery With an Interoperable Algorithm Using an Alternative Insulin Pump
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Type 1 Diabetes
Keywords: automated insulin delivery
Lead sponsor: Imperial College London
Sponsor class: OTHER
Collaborators: name: DexCom, Inc.
First posted: 2022-03-28
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DEVICE_FEASIBILITY

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.

Eligibility criteria: 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

Primary outcomes:
measure: % time spent in target glucose range measured by continuous glucose monitoring (3.9-10mmol/L, 70-180mg/dL)
timeFrame: Extracted from the final 28 days of the intervention period
Secondary outcomes:
measure: % time spent in hypoglycaemia (<3.0mmol/L, 54mg/dL)
timeFrame: Extracted from the final 28 days of the intervention period
measure: % time spent in hypoglycaemia (<3.9mmol/L, 70mg/dL)
timeFrame: Extracted from the final 28 days of the intervention period
measure: % time in euglycaemia (3.9-7.8mmol/L, 70-140mg/dL)
timeFrame: Extracted from the final 28 days of the intervention period
measure: % time spent in hyperglycaemia (>10mmol/L, 180mg/dL)
timeFrame: Extracted from the final 28 days of the intervention period
measure: Number hypoglycaemic excursions (sensor glucose <3.0mmol/l for >= 20min)
timeFrame: Over 12 week intervention period
measure: Nocturnal Severe hypoglycaemia (defined as requiring third party assistance)
timeFrame: Over 12 week intervention period
measure: Severe hypoglycaemia (defined as requiring third party assistance)
timeFrame: Over 12 week intervention period
measure: Glucose variability assessed by %Coefficient of Variation (%CV)
timeFrame: Extracted from the final 28 days of the intervention period
measure: Glucose variability assessed by Mean Absolute Glucose (MAG)
timeFrame: Extracted from the final 28 days of the intervention period
measure: Glucose variability assessed by Low Blood Glucose Index (LBGI)
timeFrame: Extracted from the final 28 days of the intervention period
measure: HbA1c
timeFrame: At end of 12 week intervention period
measure: Time spent in automated insulin delivery mode
timeFrame: Over 12 week intervention period
measure: Treatment satisfaction (DTSQ, AP acceptability)
timeFrame: At end of 12 week intervention period
measure: Gold score
timeFrame: At end of 12 week intervention period
measure: Diabetes distress (DDS-17)
timeFrame: At end of 12 week intervention period
measure: Diabetes distress (PAID)
timeFrame: At end of 12 week intervention period
measure: Change in total daily insulin dose (units)
timeFrame: At end of 12 week intervention period
measure: Change in weight (kg)
timeFrame: At end of 12 week intervention period
Other outcomes:
measure: Direct Resource Utilisation Costs
timeFrame: Over 12 week intervention period
measure: Indirect Costs
timeFrame: Over 12 week intervention period
measure: Productivity lost
timeFrame: Over 12 week intervention period
Locations:
city: London
country: United Kingdom
facility: Imperial College London, Imperial College Healthcare NHS Trust
Study officials:
References: