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

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.

Study Overview

• Status: Recruiting
• Conditions: Type 1 Diabetes
• Intervention / Treatment: Device: InControl

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 Type: Interventional
• Enrollment (Anticipated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Nick Oliver; Phone Number: 07957163617; Email: nick.oliver@imperial.ac.uk

Study Locations

• United Kingdom
  • London, United Kingdom, W2 1PG
    • Recruiting
    • Imperial College London, Imperial College Healthcare NHS Trust
    • Contact: Nick Oliver; Email: nick.oliver@imperial.ac.uk
    • Principal Investigator: Monika Reddy, MRCP
    • Principal Investigator: Nick Oliver, FRCP

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Device Feasibility
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: 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).

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
% 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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
% 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
% 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
% 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
% time spent in hyperglycaemia (>10mmol/L, 180mg/dL)	Consensus measure of time in range	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	Over 12 week intervention period
Nocturnal Severe hypoglycaemia (defined as requiring third party assistance)	Consensus measure of exposure to hypoglycaemia	Over 12 week intervention period
Severe hypoglycaemia (defined as requiring third party assistance)	Consensus measure of exposure to hypoglycaemia	Over 12 week intervention period
Glucose variability assessed by %Coefficient of Variation (%CV)	Consensus measure of glucose variability	Extracted from the final 28 days of the intervention period
Glucose variability assessed by Mean Absolute Glucose (MAG)	Consensus measure of glucose variability	Extracted from the final 28 days of the intervention period
Glucose variability assessed by Low Blood Glucose Index (LBGI)	Consensus measure of glucose variability	Extracted from the final 28 days of the intervention period
HbA1c	Laboratory HbA1c assessment	At end of 12 week intervention period
Time spent in automated insulin delivery mode	% of total time that automated insulin delivery is active	Over 12 week intervention period
Treatment satisfaction (DTSQ, AP acceptability)	Validated patient reported outcome	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)	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	At end of 12 week intervention period
Diabetes distress (PAID)	Validated patient reported outcome, Problem Areas In Diabetes 20 item	At end of 12 week intervention period
Change in total daily insulin dose (units)	Total insulin delivered by system per day	At end of 12 week intervention period
Change in weight (kg)	Weight in kg	At end of 12 week intervention period

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Direct Resource Utilisation Costs	Health economic modelling exploratory outcome	Over 12 week intervention period
Indirect Costs	Health economic modelling exploratory outcome	Over 12 week intervention period
Productivity lost	Health economic modelling exploratory outcome	Over 12 week intervention period

Collaborators and Investigators

• Sponsor: Imperial College London
• Collaborators: DexCom, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2022
• Primary Completion (Anticipated): February 28, 2023
• Study Completion (Anticipated): February 28, 2023

Study Registration Dates

• First Submitted: February 17, 2022
• First Submitted That Met QC Criteria: March 17, 2022
• First Posted (Actual): March 28, 2022

Study Record Updates

• Last Update Posted (Actual): August 8, 2022
• Last Update Submitted That Met QC Criteria: August 4, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Keywords: automated insulin delivery
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Immune System Diseases; Autoimmune Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 1
• Other Study ID Numbers: 20HH5892

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No