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

Type 1 Diabetes Clinical Trial

— BELIEVE  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05299177
• Other study ID #: 20HH5892
• Status: Recruiting
• Phase: N/A
• Start date: April 1, 2022
• Est. completion date: February 28, 2023

Study information

• Verified date: August 2022
• Source: Imperial College London
• Contact: Nick Oliver
• Phone: 07957163617
• Email: nick.oliver[@]imperial.ac.uk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: February 28, 2023
• Est. primary completion date: February 28, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 1
• Type 1 Diabetes

Intervention

Device:
• InControl
Automated insulin delivery system comprising continuous glucose sensor (Dexcom G6), controller (InControl embedded in smartphone app) and insulin pump (YpsoMed Ypsopump)

Locations

Country	Name	City	State
United Kingdom	Imperial College London, Imperial College Healthcare NHS Trust	London

Sponsors (2)

Lead Sponsor	Collaborator
Imperial College London	DexCom, Inc.

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Direct Resource Utilisation Costs	Health economic modelling exploratory outcome	Over 12 week intervention period
Other	Indirect Costs	Health economic modelling exploratory outcome	Over 12 week intervention period
Other	Productivity lost	Health economic modelling exploratory outcome	Over 12 week intervention period
Primary	% 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	% 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
Secondary	% 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
Secondary	% 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
Secondary	% time spent in hyperglycaemia (>10mmol/L, 180mg/dL)	Consensus measure of time in range	Extracted from the final 28 days of the intervention period
Secondary	Number hypoglycaemic excursions (sensor glucose <3.0mmol/l for >= 20min)	Consensus measure of exposure to hypoglycaemia	Over 12 week intervention period
Secondary	Nocturnal Severe hypoglycaemia (defined as requiring third party assistance)	Consensus measure of exposure to hypoglycaemia	Over 12 week intervention period
Secondary	Severe hypoglycaemia (defined as requiring third party assistance)	Consensus measure of exposure to hypoglycaemia	Over 12 week intervention period
Secondary	Glucose variability assessed by %Coefficient of Variation (%CV)	Consensus measure of glucose variability	Extracted from the final 28 days of the intervention period
Secondary	Glucose variability assessed by Mean Absolute Glucose (MAG)	Consensus measure of glucose variability	Extracted from the final 28 days of the intervention period
Secondary	Glucose variability assessed by Low Blood Glucose Index (LBGI)	Consensus measure of glucose variability	Extracted from the final 28 days of the intervention period
Secondary	HbA1c	Laboratory HbA1c assessment	At end of 12 week intervention period
Secondary	Time spent in automated insulin delivery mode	% of total time that automated insulin delivery is active	Over 12 week intervention period
Secondary	Treatment satisfaction (DTSQ, AP acceptability)	Validated patient reported outcome	At end of 12 week intervention period
Secondary	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
Secondary	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
Secondary	Diabetes distress (PAID)	Validated patient reported outcome, Problem Areas In Diabetes 20 item	At end of 12 week intervention period
Secondary	Change in total daily insulin dose (units)	Total insulin delivered by system per day	At end of 12 week intervention period
Secondary	Change in weight (kg)	Weight in kg	At end of 12 week intervention period