NCT01440140

Brief Summary

The main study objective is to compare real-time continuous subcutaneous glucose monitoring (CGM) combined with overnight automated closed-loop glucose control, and real-time CGM alone in the home setting.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
24

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Dec 2012

Shorter than P25 for phase_2

Geographic Reach
1 country

3 active sites

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

First Submitted

Initial submission to the registry

September 20, 2011

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 26, 2011

Completed
1.2 years until next milestone

Study Start

First participant enrolled

December 1, 2012

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2014

Completed
Last Updated

January 29, 2014

Status Verified

January 1, 2014

Enrollment Period

1 year

First QC Date

September 20, 2011

Last Update Submit

January 28, 2014

Conditions

Type 1 Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

  • Percentage of CGM (Continuous glucose monitoring) values in target (3.9 - 8.0 mmol/l).

    Participants will be assessed overnight (00:00 to 07:00) for 4 weeks in each arm.

    4 weeks

Secondary Outcomes (3)

  • Percentage of CGM values below 3.9 mmol/l.

    4 weeks

  • Time spent with glucose levels below 3.9 mmol/l and above 8.0 mmol/l, as recorded by CGM and other CGM-based metrics

    4 weeks

  • Glycaemic control assessed by fructosamine and HbA1c

    4 weeks

Study Arms (2)

Closed loop (algorithm)

EXPERIMENTAL
Other: Closed-loop

Open loop

PLACEBO COMPARATOR
Other: Conventional insulin pump delivery

Interventions

Closed-loopOTHER

Subcutaneous delivery of Novorapid insulin, dose calculated by control algorithm, based on continuous glucose sensor readings.

Also known as: Automated CL
Closed loop (algorithm)
Conventional insulin pump deliveryOTHER

Subcutaneous delivery of Novorapid insulin according to usual pump regime

Open loop

Eligibility Criteria

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

You may qualify if:

  • Type 1 diabetes, as defined by WHO for at least 6 months or confirmed C-peptide negative.
  • On insulin pump therapy for at least 3 months

You may not qualify if:

  • Non-type 1 diabetes mellitus
  • Any physical/psychological disease likely to interfere with the study
  • Taking medication likely to interfere with interpretation of the results
  • Known/suspected allergy against insulin
  • Patients with clinically significant nephropathy, neuropathy or retinopathy as judged by the investigator
  • Ongoing severe recurrent hypoglycaemia as judged by the investigator.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Addenbrooke's Hospital

Cambridge, CB2 0QQ, United Kingdom

Location

King's College London

London, SE5 9RJ, United Kingdom

Location

Northern General Hospital

Sheffield, S5 7AU, United Kingdom

Location

Related Publications (3)

  • Thabit H, Elleri D, Leelarathna L, Allen J, Lubina-Solomon A, Stadler M, Walkinshaw E, Iqbal A, Choudhary P, Wilinska M, Barnard K, Heller S, Amiel S, Evans M, Dunger D, Hovorka R. Unsupervised overnight closed loop insulin delivery during free living: analysis of randomised cross-over home studies in adults and adolescents with type 1 diabetes. Lancet. 2015 Feb 26;385 Suppl 1:S96. doi: 10.1016/S0140-6736(15)60411-1.

    PMID: 26312919DERIVED

  • Thabit H, Leelarathna L, Wilinska ME, Elleri D, Allen JM, Lubina-Solomon A, Walkinshaw E, Stadler M, Choudhary P, Mader JK, Dellweg S, Benesch C, Pieber TR, Arnolds S, Heller SR, Amiel SA, Dunger D, Evans ML, Hovorka R. Accuracy of Continuous Glucose Monitoring During Three Closed-Loop Home Studies Under Free-Living Conditions. Diabetes Technol Ther. 2015 Nov;17(11):801-7. doi: 10.1089/dia.2015.0062. Epub 2015 Aug 4.

    PMID: 26241693DERIVED

  • Thabit H, Lubina-Solomon A, Stadler M, Leelarathna L, Walkinshaw E, Pernet A, Allen JM, Iqbal A, Choudhary P, Kumareswaran K, Nodale M, Nisbet C, Wilinska ME, Barnard KD, Dunger DB, Heller SR, Amiel SA, Evans ML, Hovorka R. Home use of closed-loop insulin delivery for overnight glucose control in adults with type 1 diabetes: a 4-week, multicentre, randomised crossover study. Lancet Diabetes Endocrinol. 2014 Sep;2(9):701-9. doi: 10.1016/S2213-8587(14)70114-7. Epub 2014 Jun 16.

    PMID: 24943065DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

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

Study Officials

  • Roman Hovorka, PhD, MSc, BSc

    University of Cambridge

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Investigator

Study Record Dates

First Submitted

September 20, 2011

First Posted

September 26, 2011

Study Start

December 1, 2012

Primary Completion

December 1, 2013

Study Completion

January 1, 2014

Last Updated

January 29, 2014

Record last verified: 2014-01

Locations

GB(3)