NCT01534013

Brief Summary

The purpose of the study is to assess the safety and efficacy of the Imperial College closed loop insulin delivery system (artificial pancreas) in subjects with type 1 diabetes.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
23

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2011

Longer than P75 for not_applicable

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

August 1, 2011

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

January 30, 2012

Completed
17 days until next milestone

First Posted

Study publicly available on registry

February 16, 2012

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2014

Completed
4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2018

Completed
1.1 years until next milestone

Results Posted

Study results publicly available

August 28, 2019

Completed
Last Updated

October 30, 2020

Status Verified

October 1, 2020

Enrollment Period

3 years

First QC Date

January 30, 2012

Results QC Date

March 20, 2019

Last Update Submit

October 29, 2020

Conditions

Type 1 Diabetes Mellitus

Keywords

Closed loop insulin delivery

Outcome Measures

Primary Outcomes (1)

  • Percentage Time in Euglycaemia

    Interstitial blood glucose will be measured every 5 minutes and venous blood glucose every 15 minutes during subject visits 3, 4 and 5 when insulin is being delivered using the closed-loop insulin delivery system. The % time in euglycaemia is to be calculated using these blood glucose values.

    18 months

Secondary Outcomes (7)

  • % Time in Hypoglycaemia

    18 months

  • % Time Spent in Hyperglycaemia

    18 months

  • Glycaemic Variability as Measured by MAGE and SD

    18 months

  • Glycaemic Risk as Measured by LBGI and HBG

    18 months

  • Closed Loop Error Grid Analysis

    18 months

  • +2 more secondary outcomes

Study Arms (2)

Closed-loop insulin delivery

EXPERIMENTAL

The closed loop device (bio-inspired artificial pancreas device, subcutaneous glucose monitor and insulin pump) will be applied to participants with type 1 diabetes

Device: The Imperial College Closed-Loop Insulin Delivery System

Open-loop (Control visit)

ACTIVE COMPARATOR

Subcutaneous glucose monitor and pump will be applied to participants with type 1 diabetes

Device: Open loop

Interventions

The Imperial College Closed-Loop Insulin Delivery SystemDEVICE

The Imperial College closed-loop insulin delivery system comprises 3 main components: the glucose sensor, the control algorithm and the insulin delivery system.

Also known as: Closed-loop insulin delivery system, Artificial pancreas, Bio-inspired artificial pancreas
Closed-loop insulin delivery
Open loopDEVICE

glucose sensor and pump

Open-loop (Control visit)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adults over 18 years of age
  • Type 1 diabetes confirmed on the basis of clinical features and a fasting c-peptide \<200nmol/L
  • Type 1 diabetes for greater than 1 year
  • Continuous subcutaneous insulin infusion for greater than 6 months
  • HbA1c \< 8.5% (69mmol/mol)

You may not qualify if:

  • Recurrent severe hypoglycaemia
  • Pregnant or planning pregnancy
  • Breastfeeding
  • Enrolled in other clinical trials
  • Have active malignancy or under investigation for malignancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Imperial College London, St Mary's Campus

London, W2 1NY, United Kingdom

Location

Related Publications (11)

  • Georgiou P, Toumazou C. A silicon pancreatic Beta cell for diabetes. IEEE Trans Biomed Circuits Syst. 2007 Mar;1(1):39-49. doi: 10.1109/TBCAS.2007.893178.

    PMID: 23851519BACKGROUND

  • Georgiou P, Toumazou C. Towards an ultra low power chemically inspired electronic beta cell for diabetes. Circuits and Systems, 2006. ISCAS 2006. Proceedings. 2006 IEEE International Symposium on, p. 173, 2006.

    BACKGROUND

  • Ho M, Georgiou P, Singhal S, Oliver NS, Toumazou C. A bio-inspired closed loop insulin delivery based on the silicon pancreatic beta-cell. Circuits and Systems, 2008. ISCAS 2008. IEEE International Symposium on, pp. 1052-1055, 2008

    BACKGROUND

  • Oliver N, Georgiou P, Johnston D, Toumazou C. A benchtop closed-loop system controlled by a bio-inspired silicon implementation of the pancreatic beta cell. J Diabetes Sci Technol. 2009 Nov 1;3(6):1419-24. doi: 10.1177/193229680900300623.

    PMID: 20144397BACKGROUND

  • Hovorka R. Continuous glucose monitoring and closed-loop systems. Diabet Med. 2006 Jan;23(1):1-12. doi: 10.1111/j.1464-5491.2005.01672.x.

    PMID: 16409558BACKGROUND

  • Nathan D, Cleary P, Backlund J, Genuth S, Lachin J, Orchard T, Raskin R, Zinman B. Diabetes Control and Complications Trial/Epidemiology of Diabetes Interventions and Complications (DCCT/EDIC) Study Research Group. Intensive diabetes treatment and cardiovascular disease in patients with type 1 diabetes,

    BACKGROUND

  • Albisser AM, Leibel BS, Ewart TG, Davidovac Z, Botz CK, Zingg W. An artificial endocrine pancreas. Diabetes. 1974 May;23(5):389-96. doi: 10.2337/diab.23.5.389. No abstract available.

    PMID: 4598089BACKGROUND

  • Schaller HC, Schaupp L, Bodenlenz M, Wilinska ME, Chassin LJ, Wach P, Vering T, Hovorka R, Pieber TR. On-line adaptive algorithm with glucose prediction capacity for subcutaneous closed loop control of glucose: evaluation under fasting conditions in patients with Type 1 diabetes. Diabet Med. 2006 Jan;23(1):90-3. doi: 10.1111/j.1464-5491.2006.01695.x.

    PMID: 16409572BACKGROUND

  • Kovatchev BP, Breton M, Man CD, Cobelli C. In silico preclinical trials: a proof of concept in closed-loop control of type 1 diabetes. J Diabetes Sci Technol. 2009 Jan;3(1):44-55. doi: 10.1177/193229680900300106.

    PMID: 19444330BACKGROUND

  • Thome-Duret V, Reach G, Gangnerau MN, Lemonnier F, Klein JC, Zhang Y, Hu Y, Wilson GS. Use of a subcutaneous glucose sensor to detect decreases in glucose concentration prior to observation in blood. Anal Chem. 1996 Nov 1;68(21):3822-6. doi: 10.1021/ac960069i.

    PMID: 8914483BACKGROUND

  • Reddy M, Herrero P, El Sharkawy M, Pesl P, Jugnee N, Thomson H, Pavitt D, Toumazou C, Johnston D, Georgiou P, Oliver N. Feasibility study of a bio-inspired artificial pancreas in adults with type 1 diabetes. Diabetes Technol Ther. 2014 Sep;16(9):550-7. doi: 10.1089/dia.2014.0009. Epub 2014 May 6.

    PMID: 24801544DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Interventions

Pancreas, Artificial

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

Artificial OrgansSurgical EquipmentEquipment and Supplies

Results Point of Contact

Title
Prof Nick Oliver
Organization
Imperial College London
nick.oliver@imperial.ac.uk
02075942433

Study Officials

  • Desmond Johnston, MBChB,PhD,FRCP

    Imperial College London

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 30, 2012

First Posted

February 16, 2012

Study Start

August 1, 2011

Primary Completion

August 1, 2014

Study Completion

August 1, 2018

Last Updated

October 30, 2020

Results First Posted

August 28, 2019

Record last verified: 2020-10

Locations

GB(1)