Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Closing the Loop in Adults With Type 1 Diabetes Under Free Living Conditions (AP@Home04_P3)

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04055480
Recruitment Status : Completed
First Posted : August 13, 2019
Last Update Posted : September 2, 2020
Sponsor:
Collaborators:
Manchester University NHS Foundation Trust
University Hospital Inselspital, Berne
Medical University of Graz
Information provided by (Responsible Party):
Dr Roman Hovorka, University of Cambridge

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 faster insulin aspart (FiAsp) is non-inferior to home use of closed-loop applying standard insulin aspart.

This is a double-blind, multi-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 insulin analogue or by an automated closed-loop system using faster insulin aspart 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 are the HbA1c, time spent with glucose levels above and below target, as recorded by CGM, and other CGM based metrics.


Condition or disease Intervention/treatment Phase
Type 1 Diabetes Device: Closed-loop using standard rapid-acting insulin Device: Closed-loop using faster insulin aspart Not Applicable

Show Show detailed description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 25 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: Double blinded
Primary Purpose: Treatment
Official Title: A Multi-centre, Randomised, Two-period, Crossover Study to Evaluate Home Use of Closed-loop Applying Faster Insulin Aspart Versus Standard Insulin Aspart
Actual Study Start Date : August 10, 2019
Actual Primary Completion Date : June 15, 2020
Actual Study Completion Date : August 30, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diabetes Type 1

Arm Intervention/treatment
Active Comparator: Closed-loop using standard rapid-acting insulin

Unsupervised home use of day and night hybrid closed loop insulin delivery system (CamAPS FX) for 8 weeks using standard rapid-acting insulin

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 to monitor CGM/insulin data.

Device: Closed-loop using standard rapid-acting insulin
Closed-loop using standard rapid-acting insulin

Experimental: Closed-loop using faster insulin aspart

Unsupervised home use of day and night hybrid closed loop insulin delivery system (CamAPS FX) for 8 weeks using faster insulin aspart

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 to monitor CGM/insulin data.

Device: Closed-loop using faster insulin aspart
Closed-loop using faster insulin aspart




Primary Outcome Measures :
  1. Time spent in the target glucose range from 3.9 to 10.0 mmol/l based on subcutaneous glucose monitoring (CGM). [ Time Frame: 8 week intervention period ]

Secondary Outcome Measures :
  1. Time spent above target glucose (3.9 to 10.0 mmol/l) based on continuous subcutaneous glucose monitoring (CGM) [ Time Frame: 8 week intervention period ]
  2. Time spent below target glucose (3.9 to 10.0 mmol/l) based on continuous subcutaneous glucose monitoring (CGM) [ Time Frame: 8 week intervention period ]
  3. Average, standard deviation and coefficient of variation of glucose levels based on continuous subcutaneous glucose monitoring [ Time Frame: 8 week intervention period ]
  4. The time with glucose levels < 3.5 mmol/l <3.0mmol/l and <2.8 mmol/l based on continuous subcutaneous glucose monitoring [ Time Frame: 8 week intervention period ]
  5. The time with glucose levels in the significant hyperglycaemia, as based on continuous subcutaneous glucose monitoring (glucose levels > 16.7 mmol/l) [ Time Frame: 8 week intervention period ]
  6. Low Blood Glucose Index (LBGI) based on continuous subcutaneous glucose monitoring [ Time Frame: 8 week intervention period ]
  7. Total, basal and bolus insulin dose [ Time Frame: 8 week intervention period ]

Other Outcome Measures:
  1. 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. [ Time Frame: Through study completion, an average of 5 months ]
  2. Utility evaluation is the frequency and duration of use of the closed-loop system at home. [ Time Frame: 8 week intervention period ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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

Inclusion Criteria:

  1. The subject has type 1 diabetes as defined by WHO
  2. The subject is 18 years of age or older
  3. The subject will have been on an insulin pump for at least 6 months with good knowledge of insulin self-adjustment including carbohydrate counting
  4. 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)
  5. HbA1c <10% (86mmol/mol) for phase 3, based on analysis from central laboratory or equivalent
  6. The subject is willing to perform regular finger-prick blood glucose monitoring, with at least 2 measurements per day
  7. The subject is willing to wear closed-loop system at home and at work place
  8. The subject is willing to follow study specific instructions including the use of bolus calculator for all meals / snacks
  9. The subject is willing to upload pump and CGM data at regular intervals
  10. Female subjects of child bearing age should be on effective contraception and must have a negative urine-HCG pregnancy test at screening.

Exclusion Criteria:

  1. Non-type 1 diabetes mellitus
  2. Subjects who are living alone
  3. Any other physical or psychological disease or condition likely to interfere with the normal conduct of the study and interpretation of the study results
  4. Current treatment with drugs known to have significant interference with glucose metabolism, such as systemic corticosteroids, as judged by the investigator
  5. Known or suspected allergy against insulin or previous reaction to FiAsp
  6. Subjects with clinically significant nephropathy (eGFR < 45ml/min), neuropathy or active retinopathy (defined as presence of maculopathy or more than background diabetic retinopathy changes) as judged by the investigator
  7. 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.)
  8. Total daily insulin dose > 2 IU/kg/day
  9. Subject is pregnant or breast feeding or planning pregnancy within next 10 months
  10. Severe visual impairment
  11. Severe hearing impairment
  12. Lack of reliable telephone facility for contact
  13. Subject not proficient in English (UK), French (Switzerland) or German (Germany, Switzerland and Austria)

Additional exclusion criteria specific for Austria

  1. Positive results on urine drug screen (amphetamines/metamphetamines, barbiturates, benzodiazepines, cannabinoids, cocaine, opiates).
  2. Positive alcohol breath test.
  3. Positive reaction to any of the following tests: hepatitis B surface (HBs) antigen, anti-hepatitis C virus (anti-HCV) antibodies, anti-human immunodeficiency virus (HIV) 1 antibodies, anti-HIV2 antibodies.

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): NCT04055480


Locations
Layout table for location information
Austria
Medical University of Graz
Graz, Austria
Switzerland
Inselspital, Bern University Hospital
Bern, Switzerland
United Kingdom
Cambridge University Hospitals NHS Foundation Trust
Cambridge, United Kingdom, CB2 0QQ
Manchester Royal Infirmary, Central Manchester University Hospitals NHS Foundation Trust
Manchester, United Kingdom
Sponsors and Collaborators
University of Cambridge
Manchester University NHS Foundation Trust
University Hospital Inselspital, Berne
Medical University of Graz
Investigators
Layout table for investigator information
Principal Investigator: Roman Hovorka University of Cambridge
Layout table for additonal information
Responsible Party: Dr Roman Hovorka, Professor of Metabolic Technology, University of Cambridge
ClinicalTrials.gov Identifier: NCT04055480    
Other Study ID Numbers: 136248_APHome04
First Posted: August 13, 2019    Key Record Dates
Last Update Posted: September 2, 2020
Last Verified: August 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description:

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. To gain access, data requestors will need to sign a data access agreement.

Fully anonymised data may be shared with third parties (EU or non-EU based) for the purposes of advancing management and treatment of diabetes.

Supporting Materials: Study Protocol
Statistical Analysis Plan (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.

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Dr Roman Hovorka, University of Cambridge:
closed-loop
artificial pancreas
insulin
Additional relevant MeSH terms:
Layout table for MeSH terms
Diabetes Mellitus, Type 1
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Insulin
Insulin, Globin Zinc
Insulin Aspart
Insulin, Short-Acting
Hypoglycemic Agents
Physiological Effects of Drugs