Condition category
Nutritional, Metabolic, Endocrine
Date applied
16/01/2014
Date assigned
16/01/2014
Last edited
29/08/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Ms Josephine Hayes

ORCID ID

Contact details

Wellcome Trust-MRC Institute of Metabolic Science
Addenbrookes Hospital
Hills Road
Cambridge
CB2 0QQ
United Kingdom
jfh31@cam.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

15892

Study information

Scientific title

Acronym

Multicentre closed-loop home study in young people with type1 diabetes

Study hypothesis

An open-label, three-centre, randomised, two-period, crossover study to assess the efficacy, safety and utility of real-time continuous subcutaneous glucose monitoring combined with overnight closed-loop glucose control in the home setting in comparison with realtime continuous subcutaneous glucose monitoring alone in children and adolescents with type 1 diabetes on subcutaneous insulin infusion pump therapy

Ethics approval

13/EE/0120

Study design

Randomised; Interventional; Design type: Treatment

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Topic: Diabetes Research Network, Medicines for Children Research Network; Subtopic: Type 1 , All Diagnoses; Disease: Diabetic Control, All Diseases

Intervention

1. Realtime CGM + overnight CL
2. Realtime CGM alone

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Time spent overnight in the target glucose range (3.9 to 8.0 mmol/l)

Secondary outcome measures

Not provided at time of registration

Overall trial start date

10/12/2013

Overall trial end date

31/12/2014

Reason abandoned

Eligibility

Participant inclusion criteria

1. The subject is between 6 and 18 years of age (inclusive)
2. The subject has type 1 diabetes, as defined by WHO for at least 1 year or is confirmed Cpeptide
negative
3. The subject will have been an insulin pump user for at least 3 months, with good knowledge of insulin selfadjustment
as judged by theinvestigator.
4. The subject is willing to perform regular fingerprick
blood glucose monitoring, with at least 4 blood glucose
measurements taken every day
5. HbA1c = 10 % based on analysis from central laboratory or equivalent
6. The subject is literate in English

Participant type

Patient

Age group

Child

Gender

Both

Target number of participants

Planned Sample Size: 24; UK Sample Size: 24

Participant exclusion criteria

1. Known or suspected allergy against insulin
2. Nontype
1 diabetes mellitus including those secondary to chronic disease
3. Untreated celiac disease
4. Any other physical or psychological disease likely to interfere with the normal conduct of the study and interpretation
of the study results as judged by the investigator
5. Current treatment with drugs known to interfere with glucose metabolism, eg systemic corticosteroids, nonselective
betablockers
and MAO inhibitors etc
6. Known or suspected allergy against insulin
7. Subjects with clinical significant nephropathy, neuropathy or proliferative retinopathy as judged by the investigator
8. Total daily insulin dose = 2 IU/kg/day
9. Total daily insulin dose < 10 IU/day
10. Pregnancy, planned pregnancy, or breast feeding
11. Severe visual impairment
12. Severe hearing impairment
13. Subjects using implanted internal pacemaker

Recruitment start date

10/12/2013

Recruitment end date

31/12/2014

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Wellcome Trust-MRC Institute of Metabolic Science
Cambridge
CB2 0QQ
United Kingdom

Sponsor information

Organisation

Cambridge University Hospitals NHS Foundation Trust (UK)

Sponsor details

Children's Service
Box No 181
Addenbrookes Hospital
Hills Road
Cambridge
CB2 0QQ
United Kingdom

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Charity

Funder name

Juvenile Diabetes Research Foundation Limited (JDRF) (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes