Condition category
Nutritional, Metabolic, Endocrine
Date applied
30/01/2014
Date assigned
30/01/2014
Last edited
30/01/2014
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

16002

Study information

Scientific title

Acronym

Automated closed-loop in children and adolescents with T1D

Study hypothesis

An openlabel,
singlecentre,
randomised, 2period
crossover
study to assess the efficacy and safety of a novel
automated overnight closedloop
glucose control system on day 1 of continuous glucose monitoring sensor insertion
in comparison to day 3 to 4 after sensor insertion in children and adolescents with type 1 diabetes

Ethics approval

13/WM/0498

Study design

Randomised; Interventional; Design type: Treatment

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Treatment

Patient information sheet

Condition

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

Intervention

Primary Intervention, Sensor insertion for the Continuous Glucose monitor (CGM)

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Primary Outcome; Timepoint(s): The primary outcome measure is time spent with plasma glucose concentration in the target range (3.9

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/01/2014

Overall trial end date

01/09/2014

Reason abandoned

Eligibility

Participant inclusion criteria

1. The subject is between 6 and 18 years of age
2. The subject has had type 1 diabetes, as defined by WHO criteria 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 a good knowledge of insulin dose adjustment
4. HbA1c between below 11 % based on analysis from central laboratory
5. The subject is literate in English
6. The subject is willing to undertake all study related activities

Participant type

Patient

Age group

Child

Gender

Both

Target number of participants

Planned Sample Size: 12; UK Sample Size: 12

Participant exclusion criteria

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

Recruitment start date

01/01/2014

Recruitment end date

01/09/2014

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

Research organisation

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