Closing the Loop in Adults With Type 1 Diabetes Under Free Living Conditions (AP@Home04_Phase 4)

NCT05257460 | Completed

• 1 other identifier: 136248_Version_7.1
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

Brief Summary

The main objective of this study is to determine whether home use of day and night closed loop insulin delivery under free living conditions applying ultra-rapid insulin lispro (Lyumjev) is superior to home use of closed-loop applying standard insulin lispro (Humalog). This is a double-blind, single-centre, randomised, crossover design study, involving a run-in period followed by two study periods during which glucose levels will be controlled either by an automated closed-loop system using standard rapid acting Humalog or by an automated closed-loop system using ultra-rapid Lispro in random order. Subjects will receive appropriate training in the safe use of closed-loop insulin delivery system. Subjects will have regular contact with the study team during the home study phase including 24/7 telephone support. The primary outcome is time spent in target range between 3.9 and 10.0 mmol/L as recorded by CGM during home stay. Secondary outcomes include time spent with glucose levels above and below target, as recorded by CGM, and other CGM based metrics.

Conditions

Type 1 Diabetes

Outcome Measures

Primary Outcomes (1)

• Time spent in the target glucose range from 3.9 to 10.0 mmol/l based on continuous glucose monitoring (CGM)

  8-weeks

Secondary Outcomes (10)

• Time spent above target glucose range (>10.0 mmol/l) based on continuous glucose monitoring (CGM)

  8-weeks

• Time spent below target glucose range (<3.9 mmol/l) based on continuous glucose monitoring (CGM)

  8-weeks

• Average of glucose levels based on continuous glucose monitoring

  8-weeks

• Standard deviation of glucose levels based on continuous glucose monitoring

  8-weeks

• Coefficient of variation of glucose levels based on continuous glucose monitoring

  8-weeks

Other Outcomes (2)

• Safety evaluation will comprise the number of episodes of hypoglycaemia, significant ketonemia (>3.0mmol/l) as well as nature and severity of any other adverse events.

  Through study completion (up to 5 months)

• Utility evaluation is the frequency and duration of use of the closed-loop system at home

  8-weeks

Study Arms (2)

Closed-loop using standard rapid-acting insulin lispro

ACTIVE COMPARATOR

Unsupervised home use of day and night hybrid closed loop insulin delivery system (CamAPS FX) for 8 weeks using standard rapid-acting insulin lispro. The CamAPS FX closed-loop system comprises Dana insulin pump (Diabecare, Sooil, Seoul, South Korea) Dexcom G6 real-time CGM sensor (Dexcom, Northridge, CA, USA), an Android smartphone hosting CamAPS FX Application with the Cambridge model predictive control algorithm and communicating wirelessly with the insulin pump Glooko/Diasend cloud upload system.

Device: Hybrid closed-loop using standard insulin lispro

Closed-loop using ultra-rapid insulin lispro

EXPERIMENTAL

Unsupervised home use of day and night hybrid closed loop insulin delivery system (CamAPS FX) for 8 weeks using ultra-rapid insulin lispro. The CamAPS FX closed-loop system comprises Dana insulin pump (Diabecare, Sooil, Seoul, South Korea) Dexcom G6 real-time CGM sensor (Dexcom, Northridge, CA, USA), an Android smartphone hosting CamAPS FX Application with the Cambridge model predictive control algorithm and communicating wirelessly with the insulin pump Glooko/Diasend cloud upload system.

Device: Hybrid closed-loop using ultra-rapid insulin lispro

Interventions

Hybrid closed-loop using ultra-rapid insulin lispro DEVICE

Hybrid closed-loop using ultra-rapid insulin lispro

Closed-loop using ultra-rapid insulin lispro

Hybrid closed-loop using standard insulin lispro DEVICE

Hybrid closed-loop using standard insulin lispro

Closed-loop using standard rapid-acting insulin lispro

Eligibility Criteria

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

You may qualify if:

• The subject has type 1 diabetes as defined by WHO
• The subject is 18 years of age or older
• The subject will have been on an insulin pump for at least 6 months with good knowledge of insulin self-adjustment including carbohydrate counting
• The subject is treated with one of the rapid acting or ultra-rapid acting insulin analogues (Insulin Aspart, faster acting insulin Aspart, Insulin Lispro or Insulin Glulisine)
• HbA1c \<10% (86mmol/mol) based on analysis from central laboratory or equivalent
• The subject is willing to wear closed-loop system at home and at work place
• The subject is willing to follow study specific instructions including the use of bolus calculator for all meals / snacks
• The subject is willing to upload pump and CGM data at regular intervals
• Female subjects of child bearing age should be on effective contraception and must have a negative urine-HCG pregnancy test at screening.

You may not qualify if:

• Non-type 1 diabetes mellitus
• Any other physical or psychological disease or condition likely to interfere with the normal conduct of the study and interpretation of the study results
• Current treatment with drugs known to have significant interference with glucose metabolism, such as systemic corticosteroids, as judged by the investigator
• Known or suspected allergy against insulin or previous reaction to FiAsp
• More than one episode of severe hypoglycaemia as defined by American Diabetes Association (42) in preceding 12 months (Severe hypoglycaemia is defined as an event requiring assistance of another person to actively administer carbohydrates, glucagon, or take other corrective actions including episodes of hypoglycaemia severe enough to cause unconsciousness, seizures or attendance at hospital.)
• Total daily insulin dose \> 2 IU/kg/day
• Subject is pregnant or breast feeding or planning pregnancy within next 10 months
• Severe visual impairment
• Severe hearing impairment
• Lack of reliable telephone facility for contact
• Subject not proficient in English

Sponsors & Collaborators

• University of Cambridge: lead

Study Sites (1)

Cambridge University Hospitals NHS Foundation Trust

Cambridge, CB2 0QQ, United Kingdom

Location

Related Publications (2)

• Haliloglu B, Boughton CK, Lakshman R, Ware J, Nwokolo M, Thabit H, Mader JK, Bally L, Leelarathna L, Wilinska ME, Allen JM, Hartnell S, Evans ML, Hovorka R. Postprandial Glucose Excursions with Ultra-Rapid Insulin Analogs in Hybrid Closed-Loop Therapy for Adults with Type 1 Diabetes. Diabetes Technol Ther. 2024 Jul;26(7):449-456. doi: 10.1089/dia.2023.0509. Epub 2024 Feb 27.

  PMID: 38315506 DERIVED

• Nwokolo M, Lakshman R, Hartnell S, Alwan H, Ware J, Allen JM, Wilinska ME, Evans ML, Hovorka R, Boughton CK. CamAPS FX Hybrid Closed-Loop with Ultra-Rapid Lispro Compared with Standard Lispro in Adults with Type 1 Diabetes: A Double-Blind, Randomized, Crossover Study. Diabetes Technol Ther. 2023 Dec;25(12):856-863. doi: 10.1089/dia.2023.0262.

  PMID: 37823892 DERIVED

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: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Metabolic Technology

Study Record Dates

• First Submitted: February 7, 2022
• First Posted: February 25, 2022
• Study Start: January 25, 2022
• Primary Completion: December 28, 2022
• Study Completion: March 25, 2023
• Last Updated: May 9, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Study protocol, statistical analysis plan and fully anonymised individual participant data that underlie the results reported in the manuscript will be available 6 months following publication and ending 36 months following manuscript publication to investigators whose proposed use of the data has been approved by an independent review committee identified for this purpose, to achieve aims in the approved proposal. Proposals should be directed to rh347@cam.ac.uk and may be submitted up to 36 months following article publication.
• Access Criteria: Study protocol, statistical analysis plan and fully anonymised individual participant data that underlie the results reported in the manuscript will be available 6 months following publication and ending 36 months following manuscript publication to investigators whose proposed use of the data has been approved by an independent review committee identified for this purpose, to achieve aims in the approved proposal. Proposals should be directed to rh347@cam.ac.uk and may be submitted up to 36 months following article publication.

Locations

GB (1)