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Closed-loop in Adults With T2D Requiring Dialysis (AP-Renal)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04025775
Recruitment Status : Recruiting
First Posted : July 19, 2019
Last Update Posted : February 18, 2020
Sponsor:
Collaborator:
University Hospital Inselspital, Berne
Information provided by (Responsible Party):
Dr Roman Hovorka, University of Cambridge

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.


Condition or disease Intervention/treatment Phase
Type 2 Diabetes End Stage Renal Disease Device: CamAPS HX Closed-loop Other: Multiple Daily Insulin Injections (Control) Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-label, Two-centre, Randomised, 2-period Cross-over Study to Assess the Efficacy, Safety and Utility of Fully Closed-loop Insulin Delivery in Comparison With Standard Care, in Adults With Type 2 Diabetes Requiring Maintenance Dialysis
Actual Study Start Date : August 1, 2019
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2020


Arm Intervention/treatment
Experimental: Closed loop insulin delivery

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

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.

Active Comparator: Standard therapy
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)
Multiple Daily Insulin Injections with masked Dexcom G6 CGM sensor (Dexcom, Northridge, CA, USA)




Primary Outcome Measures :
  1. Time in the target glucose range (5.6 to 10.0 mmol/l) [ Time Frame: 20 day intervention period ]
    Percentage of time spent with sensor glucose readings in the target range from 5.6 to 10.0


Secondary Outcome Measures :
  1. Time spent above target glucose (10.0 mmol/l) [ Time Frame: 20 day intervention period ]
    Both armsPercentage of time spent with sensor glucose readings above target glucose (10.0 mmol/l)

  2. Mean glucose [ Time Frame: 20 day intervention period ]
    Mean sensor glucose level

  3. Time spent in hypoglycaemia (<3.9 mmol/l) [ Time Frame: 20 day intervention period ]
    Percentage of time spent with sensor glucose readings <3.9 mmol/l

  4. Time spent below target glucose (5.6 mmol/l) [ Time Frame: 20 day intervention period ]
    Percentage of time spent with sensor glucose readings below target glucose (5.6 mmol/l)

  5. Standard deviation of glucose levels [ Time Frame: 20 day intervention period ]
    Standard deviation of glucose levels

  6. Coefficient of variation of glucose levels [ Time Frame: 20 day intervention period ]
    Coefficient of variation of glucose levels

  7. Time spent below <3.0 mmol/l [ Time Frame: 20 day intervention period ]
    Percentage of time spent with sensor glucose readings <3.0 mmol/l

  8. Time in significant hyperglycaemia (> 20 mmol/l) [ Time Frame: 20 day intervention period ]
    Percentage of time with glucose levels in significant hyperglycaemia (> 20 mmol/l)

  9. Total, basal and bolus insulin dose [ Time Frame: 20 day intervention period ]
    Average daily total, basal and bolus insulin requirements

  10. AUC of glucose below 3.5 mmol/l [ Time Frame: 20 day intervention period ]
    Area under the curve of sensor glucose readings below 3.5mmol/l


Other Outcome Measures:
  1. Number of episodes of severe hypoglycaemia [ Time Frame: 20 day intervention period ]
    Safety evaluation

  2. Number of subjects experiencing severe hypoglycaemia [ Time Frame: 20 day intervention period ]
    Safety evaluation

  3. Frequency and nature of other adverse events or serious adverse events [ Time Frame: 20 day intervention period ]
    Safety evaluation

  4. Percentage of time of closed-loop operation [ Time Frame: 20 day intervention period ]
    Utility evaluation

  5. Percentage of time of CGM availability [ Time Frame: 20 day intervention period ]
    Utility evaluation

  6. Average inter-dialytic weight gain [ Time Frame: 20 day intervention period ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04025775


Contacts
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Contact: Roman Hovorka, PhD +44 (0)1223 762 862 rh347@cam.ac.uk

Locations
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Switzerland
Inselspital, Bern University Hospital Not yet recruiting
Bern, Switzerland
Contact: Lia Bally, MD, PhD         
Principal Investigator: Lia Bally, MD, PhD         
United Kingdom
Cambridge University Hospitals NHS Foundation Trust Recruiting
Cambridge, United Kingdom, CB2 0QQ
Contact: Roman Hovorka, PhD       rh347@cam.ac.uk   
Principal Investigator: Andrew Fry, MD, PhD         
Sub-Investigator: Charlotte Boughton, MD, PhD         
Sponsors and Collaborators
University of Cambridge
University Hospital Inselspital, Berne
Investigators
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Study Director: Roman Hovorka, PhD University of Cambridge
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Responsible Party: Dr Roman Hovorka, Professor of Metabolic Technology, University of Cambridge
ClinicalTrials.gov Identifier: NCT04025775    
Other Study ID Numbers: AP-Renal
First Posted: July 19, 2019    Key Record Dates
Last Update Posted: February 18, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Fully anonymised data may be shared with third parties (EU or non-EU based) for the purposes of advancing management and treatment of diabetes.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Kidney Failure, Chronic
Diabetes Mellitus, Type 2
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Kidney Diseases
Urologic Diseases
Renal Insufficiency, Chronic
Renal Insufficiency
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs