Closed-loop in Adults With T2D Requiring Dialysis

NCT04025775 | Completed DMC

• 1 other identifier: AP-Renal
• Study Type: interventional
• Target: 27
• Locations: 2 countries
• Sites: 2

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 a 20 day period in adults with type 2 diabetes (T2D) requiring maintenance dialysis. 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, two-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 20 days long with a 2-4 week washout period between treatments. A total of up to 40 adults with T2D requiring maintenance dialysis will be recruited through outpatient clinics or the dialysis unit, to allow for 32 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 5.6 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; End Stage Renal Disease

Outcome Measures

Primary Outcomes (1)

• Time in the target glucose range (5.6 to 10.0 mmol/l)

  Percentage of time spent with sensor glucose readings in the target range from 5.6 to 10.0

  20 day intervention period

Secondary Outcomes (10)

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

  20 day intervention period

• Mean glucose

  20 day intervention period

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

  20 day intervention period

• Time spent below target glucose (5.6 mmol/l)

  20 day intervention period

• Standard deviation of glucose levels

  20 day intervention period

Other Outcomes (6)

• Number of episodes of severe hypoglycaemia

  20 day intervention period

• Number of subjects experiencing severe hypoglycaemia

  20 day intervention period

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

  20 day intervention period

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 20 days 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 20 day study period.Participants will be wear a masked continuous glucose monitoring (CGM) system during the 20 day 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:

• The subject is age 18 years or over
• Diagnosis of type 2 diabetes using standard diagnostic practice
• The subject requires maintenance dialysis
• The subject requires 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
• The subject is literate in English (UK) or German (Switzerland)
• The subject is willing to wear study devices 24/7 during intervention arm and follow study specific instructions

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 or unable to tolerate tape adhesive in the area of sensor placement
• 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
• Insel Gruppe AG, University Hospital Bern: collaborator

Study Sites (2)

Inselspital, Bern University Hospital

Bern, Switzerland

Location

Cambridge University Hospitals NHS Foundation Trust

Cambridge, CB2 0QQ, United Kingdom

Location

Related Publications (1)

• Boughton CK, Tripyla A, Hartnell S, Daly A, Herzig D, Wilinska ME, Czerlau C, Fry A, Bally L, Hovorka R. Fully automated closed-loop glucose control compared with standard insulin therapy in adults with type 2 diabetes requiring dialysis: an open-label, randomized crossover trial. Nat Med. 2021 Aug;27(8):1471-1476. doi: 10.1038/s41591-021-01453-z. Epub 2021 Aug 4.

  PMID: 34349267 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Kidney Failure, Chronic

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Roman Hovorka, PhD

  University of Cambridge

  STUDY DIRECTOR

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: July 16, 2019
• First Posted: July 19, 2019
• Study Start: August 1, 2019
• Primary Completion: December 31, 2020
• Study Completion: March 1, 2021
• Last Updated: May 17, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will share

Locations

GB (1); CH (1)