NCT02129868

Brief Summary

People with type 1 diabetes need regular insulin injections or continuous delivery of insulin using a pump. Keeping blood sugars in the normal range is known to reduce long term complications. However, achieving treatment goals can be very difficult due to the risk of low glucose levels (hypoglycaemia). One solution is to use a system where the amount of insulin injected closely matches the blood sugar levels on a continuous basis. This can be achieved by what is known as a "closed loop system" where a small glucose sensor placed under the skin communicates with a computer containing an algorithm that drives a subcutaneous insulin pump. Previous studies conducted under carefully controlled clinical research facility environment, in Cambridge, United Kingdom, as well as several other centres have shown that closed-loop glucose control is superior to usual insulin pump therapy. The next logical step in the development pathway is to test closed loop systems in the home environment. An essential requirement for conducting closed-loop studies outside clinical research facility is an automated system where wireless data transmission takes place between the glucose sensor and insulin pump. The purpose of the present study is to evaluate the efficacy and safety of automated overnight closed-loop, in children and adolescents with type 1 diabetes, using a novel system which has greatest potential for use in the home setting. The study will take place at a clinical research facility on two occasions, using a standardised protocol. The performance of the closed-loop system will be evaluated on day 1 of continuous glucose monitoring (CGM) sensor life as compared to on days 3 to 4 of sensor life. Data and experience gained from this study will be used for further refinements and development of the system for future home use.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
13

participants targeted

Target at below P25 for not_applicable diabetes-mellitus

Timeline
Completed

Started Apr 2014

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2014

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

April 23, 2014

Completed
9 days until next milestone

First Posted

Study publicly available on registry

May 2, 2014

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2015

Completed
Last Updated

March 3, 2017

Status Verified

February 1, 2017

Enrollment Period

1 year

First QC Date

April 23, 2014

Last Update Submit

February 28, 2017

Conditions

Diabetes MellitusDiabetes Mellitus, Type 1Glucose Metabolism DisordersEndocrine System DiseasesAutoimmune Diseases

Keywords

Type 1 diabetesClosed-loop glucose controlArtificial PancreasContinuous subcutaneous insulin infusionContinuous glucose monitoring

Outcome Measures

Primary Outcomes (1)

  • Time spent with plasma glucose concentration in the target glucose range from 3.9 to 8.0 mmol/l.

    The primary outcome measure is time spent with plasma glucose concentration in the target range (3.9-8.0mmol/L) between 21:30 on Day 1 and 07:30 on Day 2 (10 hours), as obtained with closed-loop insulin delivery on day 1 of CGM sensor insertion as compared with closed-loop insulin delivery on day 3 to 4 of CGM sensor insertion.

    10 hours

Secondary Outcomes (7)

  • Time spent with plasma glucose concentration below the target range (<3.9mmol/L) between 21:30 on Day 1 and 07:30 on Day 2 (10 hours).

    10 hours

  • Time spent with plasma glucose concentration above the target range (>8mmol/L) between 21:30 on Day 1 and 07:30 on Day 2 (10 hours).

    10 hours

  • Mean and standard deviation of plasma glucose levels between 21:30 on Day 1 and 07:30 on Day 2 (10 hours).

    10 hours

  • Total insulin delivery between 21:30 on Day 1 and 07:30 on Day 2 (10 hours).

    10 hours

  • Total basal insulin delivery between 21:30 on Day 1 and 07:30 on Day 2 (10 hours).

    10 hours

  • +2 more secondary outcomes

Other Outcomes (8)

  • Percentage of time the system is functioning as intended in active closed-loop mode.

    14 hours

  • CGM failure (defined as no CGM glucose available for whatever reason; failure rate )

    14 hours

  • Problems with user interface / Android platform (failure rate)

    14 hours

  • +5 more other outcomes

Study Arms (2)

Closed-loop on day 1 of CGM sensor life

EXPERIMENTAL

Glucose level is controlled by the automated closed-loop glucose control system on day 1 after CGM sensor insertion.

Device: Closed-loop (Android Closed-Loop platform)

Closed-loop on day 3 of CGM sensor life

ACTIVE COMPARATOR

Glucose level is controlled by the automated closed-loop glucose control system on day 3 or 4 after CGM sensor insertion.

Device: Closed-loop (Android Closed-Loop platform)

Interventions

Closed-loop (Android Closed-Loop platform)DEVICE

The closed-loop system is purpose-built and comprises a hand-held computer containing a model predictive control (MPC) based glucose control algorithm and communicating with the CGM device and the insulin pump. The Android Closed-Loop platform employs the Medtronic MiniMed Paradigm® Veo™ insulin pump system with CGM capability (use of MiniLink™Transmitter and sensor). A Radiofrequency (RF) translator module translates the RF protocol to Bluetooth® technology. An Android device containing an algorithm will use sensor glucose data to calculate pump strokes.

Closed-loop on day 1 of CGM sensor lifeClosed-loop on day 3 of CGM sensor life

Eligibility Criteria

Age6 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • The subject is between 6 and 18 years of age.
  • The subject has had type 1 diabetes, as defined by WHO criteria for at least 1 year or is confirmed C-peptide negative.
  • The subject will have been an insulin pump user for at least 3 months, with a good knowledge of insulin dose adjustment.
  • HbA1c between below 11 % based on analysis from central laboratory.
  • The subject is literate in English.
  • The subject is willing to undertake all study related activities.

You may not qualify if:

  • Non-type 1 diabetes mellitus including those secondary to chronic disease.
  • Any other physical or psychological disease likely to interfere with the normal conduct of the study and interpretation of the study results.
  • Current treatment with drugs known to interfere with glucose metabolism such as systemic corticosteroids, non-selective beta-blockers and MAO inhibitors.
  • Known or suspected allergy against insulin.
  • Subjects with clinically significant nephropathy, neuropathy or proliferative retinopathy as judged by the investigator
  • Patient is pregnant, or breast feeding during the period of the study.
  • Total daily insulin dose ≥ 2 Units/kg/day
  • Total daily insulin dose \< 10 Units/day
  • Severe visual impairment
  • Severe hearing impairment
  • Subjects using implanted internal pacemaker

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Cambridge

Cambridge, CB2 0QQ, United Kingdom

Location

Related Publications (5)

  • Hovorka R, Allen JM, Elleri D, Chassin LJ, Harris J, Xing D, Kollman C, Hovorka T, Larsen AM, Nodale M, De Palma A, Wilinska ME, Acerini CL, Dunger DB. Manual closed-loop insulin delivery in children and adolescents with type 1 diabetes: a phase 2 randomised crossover trial. Lancet. 2010 Feb 27;375(9716):743-51. doi: 10.1016/S0140-6736(09)61998-X. Epub 2010 Feb 4.

    PMID: 20138357BACKGROUND

  • Hovorka R, Kumareswaran K, Harris J, Allen JM, Elleri D, Xing D, Kollman C, Nodale M, Murphy HR, Dunger DB, Amiel SA, Heller SR, Wilinska ME, Evans ML. Overnight closed loop insulin delivery (artificial pancreas) in adults with type 1 diabetes: crossover randomised controlled studies. BMJ. 2011 Apr 13;342:d1855. doi: 10.1136/bmj.d1855.

    PMID: 21493665BACKGROUND

  • Elleri D, Allen JM, Biagioni M, Kumareswaran K, Leelarathna L, Caldwell K, Nodale M, Wilinska ME, Acerini CL, Dunger DB, Hovorka R. Evaluation of a portable ambulatory prototype for automated overnight closed-loop insulin delivery in young people with type 1 diabetes. Pediatr Diabetes. 2012 Sep;13(6):449-53. doi: 10.1111/j.1399-5448.2012.00903.x. Epub 2012 Jul 23.

    PMID: 22817340BACKGROUND

  • Kumareswaran K, Elleri D, Allen JM, Harris J, Xing D, Kollman C, Nodale M, Murphy HR, Amiel SA, Heller SR, Wilinska ME, Acerini CL, Evans ML, Dunger DB, Hovorka R. Meta-analysis of overnight closed-loop randomized studies in children and adults with type 1 diabetes: the Cambridge cohort. J Diabetes Sci Technol. 2011 Nov 1;5(6):1352-62. doi: 10.1177/193229681100500606.

    PMID: 22226252BACKGROUND

  • Tauschmann M, Allen JM, Wilinska ME, Ruan Y, Thabit H, Acerini CL, Dunger DB, Hovorka R. Sensor Life and Overnight Closed Loop: A Randomized Clinical Trial. J Diabetes Sci Technol. 2017 May;11(3):513-521. doi: 10.1177/1932296816678631. Epub 2016 Nov 11.

    PMID: 27837162RESULT

MeSH Terms

Conditions

Diabetes MellitusDiabetes Mellitus, Type 1Glucose Metabolism DisordersEndocrine System DiseasesAutoimmune Diseases

Condition Hierarchy (Ancestors)

Metabolic DiseasesNutritional and Metabolic DiseasesImmune System Diseases

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
Director of Research

Study Record Dates

First Submitted

April 23, 2014

First Posted

May 2, 2014

Study Start

April 1, 2014

Primary Completion

April 1, 2015

Study Completion

April 1, 2015

Last Updated

March 3, 2017

Record last verified: 2017-02

Locations

GB(1)