Closed-loop in Adults With T2D Not Requiring Dialysis

NCT04701424 | Completed DMC

• 1 other identifier: RG97920
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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

Keywords

diabetes; type 2 diabetes; closed-loop; artificial pancreas; insulin pump therapy; continuous glucose monitoring

Outcome Measures

Primary Outcomes (1)

• Time in the target glucose range (3.9 to 10.0 mmol/l)

  Percentage of time spent with sensor glucose readings in the target range from 3.9 to 10.0mmol/l

  8 week intervention period

Secondary Outcomes (10)

• Time spent above target glucose (10.0 mmol/l)

  8 week intervention period, both arms

• Mean glucose

  8 week intervention period, both arms

• Time spent in hypoglycaemia (<3.9 mmol/l)

  8 week intervention period, both arms

• Standard deviation of glucose levels

  8 week intervention period, both arms

• Coefficient of variation of glucose levels

  8 week intervention period, both arms

Other Outcomes (5)

• Number of episodes of severe hypoglycaemia

  8 week intervention period, both arms

• Number of subjects experiencing severe hypoglycaemia

  8 week intervention period, both arms

• Frequency and nature of other adverse events or serious adverse events

  8 week intervention period, both arms

Study Arms (2)

Closed loop insulin delivery

EXPERIMENTAL

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

Device: CamAPS HX Closed-loop

Standard therapy

ACTIVE COMPARATOR

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

Other: Multiple Daily Insulin Injections (Control)

Interventions

CamAPS HX Closed-loop 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.

Closed loop insulin delivery

Multiple Daily Insulin Injections (Control) OTHER

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

Standard therapy

Eligibility Criteria

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

You may qualify if:

• Age 18 years or over
• Diagnosis of type 2 diabetes using standard diagnostic practice
• Current treatment with subcutaneous insulin
• Screening HbA1c ≤ 11% (97mmol/mol) on analysis from local laboratory
• Subject is willing to perform regular finger-prick blood glucose monitoring
• Willingness to wear study devices
• Literate in English

You may not qualify if:

• 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
• Known or suspected allergy to insulin
• Lack of reliable telephone facility for contact
• Pregnancy, planned pregnancy, or breast feeding
• Severe visual impairment
• Severe hearing impairment
• Medically documented allergy towards the adhesive (glue) of plasters
• Serious skin diseases located at places of the body, which potentially are possible to be used for localisation of the glucose sensor
• Illicit drugs abuse
• Prescription drugs abuse
• Alcohol abuse

Sponsors & Collaborators

• University of Cambridge: lead

Study Sites (1)

Cambridge University Hospitals NHS Foundation Trust

Cambridge, Cambridgeshire, CB2 0QQ, United Kingdom

Location

Related Publications (1)

• 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.

  PMID: 36631592 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Roman Hovorka, PhD

  University of Cambridge

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Metabolic Technology

Study Record Dates

• First Submitted: January 6, 2021
• First Posted: January 8, 2021
• Study Start: December 16, 2020
• Primary Completion: March 30, 2022
• Study Completion: March 30, 2022
• Last Updated: May 31, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will share

Locations

GB (1)