Type 1 Diabetes
Conditions
Keywords
automated insulin delivery
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.
Interventions
DEVICEInControl
Automated insulin delivery system comprising continuous glucose sensor (Dexcom G6), controller (InControl embedded in smartphone app) and insulin pump (YpsoMed Ypsopump)
Sponsors
DexCom, Inc.
Imperial College London
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DEVICE_FEASIBILITY
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| % time spent in target glucose range measured by continuous glucose monitoring (3.9-10mmol/L, 70-180mg/dL) | Extracted from the final 28 days of the intervention period | Consensus measure of time in range |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Glucose variability assessed by Mean Absolute Glucose (MAG) | Extracted from the final 28 days of the intervention period | Consensus measure of glucose variability |
| Diabetes distress (PAID) | At end of 12 week intervention period | Validated patient reported outcome, Problem Areas In Diabetes 20 item |
| Change in total daily insulin dose (units) | At end of 12 week intervention period | Total insulin delivered by system per day |
| Change in weight (kg) | At end of 12 week intervention period | Weight in kg |
| % time spent in hypoglycaemia (<3.0mmol/L, 54mg/dL) | Extracted from the final 28 days of the intervention period | Consensus measure of time in range |
| % time spent in hypoglycaemia (<3.9mmol/L, 70mg/dL) | Extracted from the final 28 days of the intervention period | Consensus measure of time in range |
| % time in euglycaemia (3.9-7.8mmol/L, 70-140mg/dL) | Extracted from the final 28 days of the intervention period | Consensus measure of time in range |
| % time spent in hyperglycaemia (>10mmol/L, 180mg/dL) | Extracted from the final 28 days of the intervention period | Consensus measure of time in range |
| Number hypoglycaemic excursions (sensor glucose <3.0mmol/l for >= 20min) | Over 12 week intervention period | Consensus measure of exposure to hypoglycaemia |
| Nocturnal Severe hypoglycaemia (defined as requiring third party assistance) | Over 12 week intervention period | Consensus measure of exposure to hypoglycaemia |
| Severe hypoglycaemia (defined as requiring third party assistance) | Over 12 week intervention period | Consensus measure of exposure to hypoglycaemia |
| Glucose variability assessed by %Coefficient of Variation (%CV) | Extracted from the final 28 days of the intervention period | Consensus measure of glucose variability |
| Glucose variability assessed by Low Blood Glucose Index (LBGI) | Extracted from the final 28 days of the intervention period | Consensus measure of glucose variability |
| HbA1c | At end of 12 week intervention period | Laboratory HbA1c assessment |
| Time spent in automated insulin delivery mode | Over 12 week intervention period | % of total time that automated insulin delivery is active |
| Treatment satisfaction (DTSQ, AP acceptability) | At end of 12 week intervention period | Validated patient reported outcome |
| Gold score | At end of 12 week intervention period | Validated patient reported outcome of hypoglycaemia awareness (1-7, with greater value indicating loss of awareness) |
| Diabetes distress (DDS-17) | At end of 12 week intervention period | Validated patient reported outcome, Diabetes Distress Score 17 item, higher scores mean greater distress |
Other
| Measure | Time frame | Description |
|---|---|---|
| Productivity lost | Over 12 week intervention period | Health economic modelling exploratory outcome |
| Direct Resource Utilisation Costs | Over 12 week intervention period | Health economic modelling exploratory outcome |
| Indirect Costs | Over 12 week intervention period | Health economic modelling exploratory outcome |
Countries
United Kingdom
Outcome results
None listed