Closed-loop in Adults With T2D Not Requiring Dialysis

NCT ID: NCT04701424

Last Updated: 2022-05-31

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-12-16
• Study Completion Date: 2022-03-30

Brief Summary

The main objective of this study is to determine the efficacy, safety and utility of fully automated closed-loop glucose control in the home setting over an 8 week period in adults with type 2 diabetes (T2D). This study builds on previous and on-going studies of closed-loop systems that have been performed in Cambridge in adults with type 1 diabetes in the home setting, and in adults with type 2 diabetes in the inpatient setting.

This is an open-label, single centre, randomised, cross-over study, involving two home study periods during which glucose levels will be controlled either by a fully automated closed-loop system or by participants' usual insulin therapy in random order. Each treatment arm is 8 weeks long with a 2-4 week washout period between treatments. A total of up to 30 participants with T2D will be recruited through outpatient clinics to allow for 24 completed participants available for assessment.

Participants will receive appropriate training by the research team on the safe use of the study devices (insulin pump and continuous glucose monitoring (CGM) and closed-loop insulin delivery system). Participants in the control arm will continue with standard therapy and will wear a blinded CGM system.

The primary outcome is time spent with glucose levels in the target range between 3.9 and 10.0 mmol/L as recorded by CGM. Secondary outcomes are the time spent with glucose levels above and below target, as recorded by CGM, and other CGM-based metrics in addition to insulin requirements. Safety evaluation comprises the tabulation of severe hypoglycaemic episodes.

Conditions

Type 2 Diabetes

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Closed loop insulin delivery

Unsupervised home use of day and night fully automated closed loop insulin delivery system (CamAPS HX) for 8 weeks

The CamAPS HX 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 HX Application with the Cambridge model predictive control algorithm and communicating wirelessly with the insulin pump Glooko/Diasend cloud upload system to monitor CGM/insulin data

Group Type: EXPERIMENTAL

CamAPS HX Closed-loop

Intervention Type: DEVICE

The CamAPS HX 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 HX Application with the Cambridge model predictive control algorithm and communicating wirelessly with the insulin pump Glooko/Diasend cloud upload system to monitor CGM/insulin data.

Standard therapy

Participants in the control arm will continue to follow their current diabetes management plan for the 8 week study period. Participants will be wear a masked continuous glucose monitoring (CGM) system during the 8 week study period

Group Type: ACTIVE_COMPARATOR

Multiple Daily Insulin Injections (Control)

Intervention Type: OTHER

Multiple Daily Insulin Injections with masked Dexcom G6 CGM sensor (Dexcom, Northridge, CA, USA)

Interventions

CamAPS HX Closed-loop

The CamAPS HX 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 HX Application with the Cambridge model predictive control algorithm and communicating wirelessly with the insulin pump Glooko/Diasend cloud upload system to monitor CGM/insulin data.

Intervention Type: DEVICE

Multiple Daily Insulin Injections (Control)

Multiple Daily Insulin Injections with masked Dexcom G6 CGM sensor (Dexcom, Northridge, CA, USA)

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

1. Age 18 years or over

2. Diagnosis of type 2 diabetes using standard diagnostic practice

3. Current treatment with subcutaneous insulin

4. Screening HbA1c ≤ 11% (97mmol/mol) on analysis from local laboratory

5. Subject is willing to perform regular finger-prick blood glucose monitoring

6. Willingness to wear study devices

7. Literate in English

Exclusion Criteria

1. Physical or psychological condition likely to interfere with the normal conduct of the study and interpretation of the study results as judged by the investigator

2. Known or suspected allergy to insulin

3. Lack of reliable telephone facility for contact

4. Pregnancy, planned pregnancy, or breast feeding

5. Severe visual impairment

6. Severe hearing impairment

7. Medically documented allergy towards the adhesive (glue) of plasters

8. Serious skin diseases located at places of the body, which potentially are possible to be used for localisation of the glucose sensor

9. Illicit drugs abuse

10. Prescription drugs abuse

11. Alcohol abuse

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Cambridge

OTHER

Sponsor Role: lead

Responsible Party

Dr Roman Hovorka

Professor of Metabolic Technology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Roman Hovorka, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Cambridge

Locations

Cambridge University Hospitals NHS Foundation Trust

Cambridge, Cambridgeshire, United Kingdom

Countries

United Kingdom

References

Daly AB, Boughton CK, Nwokolo M, Hartnell S, Wilinska ME, Cezar A, Evans ML, Hovorka R. Fully automated closed-loop insulin delivery in adults with type 2 diabetes: an open-label, single-center, randomized crossover trial. Nat Med. 2023 Jan;29(1):203-208. doi: 10.1038/s41591-022-02144-z. Epub 2023 Jan 11.

Reference Type: DERIVED

PMID: 36631592 (View on PubMed)

Other Identifiers

RG97920

Identifier Type: -

Identifier Source: org_study_id