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

NCT05299177 | Terminated

• 1 other identifier: 20HH5892
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

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.

Conditions

Type 1 Diabetes

Keywords

automated insulin delivery

Outcome Measures

Primary Outcomes (1)

• % 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 Outcomes (18)

• % time spent in hypoglycaemia (<3.0mmol/L, 54mg/dL)

  Extracted from the final 28 days of the intervention period

• % time spent in hypoglycaemia (<3.9mmol/L, 70mg/dL)

  Extracted from the final 28 days of the intervention period

• % time in euglycaemia (3.9-7.8mmol/L, 70-140mg/dL)

  Extracted from the final 28 days of the intervention period

• % time spent in hyperglycaemia (>10mmol/L, 180mg/dL)

  Extracted from the final 28 days of the intervention period

• Number hypoglycaemic excursions (sensor glucose <3.0mmol/l for >= 20min)

  Over 12 week intervention period

Other Outcomes (3)

• Direct Resource Utilisation Costs

  Over 12 week intervention period

• Indirect Costs

  Over 12 week intervention period

• Productivity lost

  Over 12 week intervention period

Study Arms (1)

Automated Insulin Delivery

EXPERIMENTAL

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

Interventions

InControl DEVICE

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

Automated Insulin Delivery

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Imperial College London: lead
• DexCom, Inc.: collaborator

Study Sites (1)

Imperial College London, Imperial College Healthcare NHS Trust

London, W2 1PG, United Kingdom

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 17, 2022
• First Posted: March 28, 2022
• Study Start: April 1, 2022
• Primary Completion: August 31, 2025
• Study Completion: August 31, 2025
• Last Updated: September 3, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)