Status:

TERMINATED

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

Lead Sponsor:

Imperial College London

Collaborating Sponsors:

DexCom, Inc.

Conditions:

Type 1 Diabetes

Eligibility:

All Genders

18+ years

Phase:

NA

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 t...

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 i...

Eligibility Criteria

Inclusion

  • 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

  • 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

Key Trial Info

Start Date :

April 1 2022

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

August 31 2025

Estimated Enrollment :

1 Patients enrolled

Trial Details

Trial ID

NCT05299177

Start Date

April 1 2022

End Date

August 31 2025

Last Update

September 3 2025

Active Locations (1)

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1

Imperial College London, Imperial College Healthcare NHS Trust

London, United Kingdom, W2 1PG