Condition category
Nutritional, Metabolic, Endocrine
Date applied
09/02/2010
Date assigned
06/04/2010
Last edited
12/07/2013
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

Dr Helen R Murphy

ORCID ID

Contact details

Level 4 Metabolic Research Laboratories
Institute of Metabolic Science
Box 289 Addenbrookes Hospital
Hills Road
Cambridge
CB2 0QQ
United Kingdom
+44 (0)1223 769079
hm386@medschl.cam.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

Version 1.2 Nov 11 2009

Study information

Scientific title

Evaluation of the safety and efficacy of closed loop glucose control during the activities of normal daily living in women with type 1 diabetes during pregnancy: an open label randomised cross-over study

Acronym

CLIP - 02

Study hypothesis

Null hypothesis:
The computer-based closed loop (CL) system provides glucose control which is as safe and efficacious as conventional insulin pump therapy during pregnancy in women with type 1 diabetes.

Alternative hypothesis:
The computer-based closed loop (CL) system provides better glucose control and reduced risk of hypoglycaemia than conventional insulin pump therapy during pregnancy in women with type 1 diabetes.

A pilot feasibility study of this trial was performed in 2009, registered with an ISRCTN under the title 'Closed Loop In Pregnancy: evaluation of the gut absorption rate of glucose during an evening meal and breakfast in women with type 1 diabetes throughout pregnancy (CLIP -01)', and this record can be found at http://www.controlled-trials.com/ISRCTN62568875.

Ethics approval

Essex 2 Research Ethics Committee approved on the 9th December 2009 (ref: 09/H0302/113)

Study design

Open label randomised cross-over study

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Type 1 diabetes

Intervention

Treatment arm: 24 hours closed loop insulin delivery (dose titration by computer algorithm)
Control arm: 24 hours of conventional insulin pump delivery (i.e dose titration according to fingerprick glucose levels)

Intervention type

Other

Phase

Phase II

Drug names

Primary outcome measures

Time spent with plasma glucose concentration in the target range (3.5 - 7.8 mmol/L) between 14.00 - 12.30 hours. Specific parameters will be the assessment of variability and frequency of mild and moderate hypoglycaemic events (plasma glucose less than 3.5 mmol/L and less than 2.8 mmol/L respectively), mild and moderate hyperglycaemic events (plasma glucose greater than 7.8 mmol/L and greater than 10.0 mmol/L respectively).

Secondary outcome measures

1. Total daily dose of insulin (TDD) on intervention versus control visit
2. Actiheart physical activity energy expenditure (PAEE) score during the 24 hour study visit and 24 hour free living
3. Continuous blood glucose monitored (CGM) glucose levels during the 24 hour study visit and 24 hour free living

Overall trial start date

01/03/2010

Overall trial end date

28/02/2011

Reason abandoned

Eligibility

Participant inclusion criteria

1. Signed informed consent obtained before study-related activities. Study-related activities are any procedure that would not have been performed during standard medical care.
2. The participant is between 16 and 44 years of age (inclusive), female only
3. The participant has type 1 diabetes (T1DM), as defined by World Health Organisation (WHO) for at least 12 months and has had a viable singleton pregnancy confirmed by ultrasound
4. The participant has been commenced on insulin pump therapy during or prior to pregnancy
5. The participant is able and willing to use a real time continuous sensor

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

12

Participant exclusion criteria

1. Non-type 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 such as coeliac disease or untreated hypothyroidism
3. Current treatment with drugs known to interfere with glucose metabolism such as systemic corticosteroids, non-selective beta-blockers and monoamine oxidase (MAO) inhibitors
4. Known or suspected allergy against insulin
5. Women with clinically significant nephropathy, neuropathy or proliferative retinopathy as judged by the investigator
6. Documented gastroparesis
7. Very poor glycaemic control i.e. HbA1c greater than or equal to 10%
8. Significant obesity, i.e., body mass index (BMI) at booking greater than 35 kg/m^2
9. Total daily insulin dose greater than 1.5 IU/kg at booking
10. Women who have conceived with in vitro fertilisation (IVF) or assisted reproductive techniques

Recruitment start date

01/03/2010

Recruitment end date

28/02/2011

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Level 4 Metabolic Research Laboratories
Cambridge
CB2 0QQ
United Kingdom

Sponsor information

Organisation

Cambridge University Hospital NHS Foundation Trust (UK)

Sponsor details

Addenbrookes Hospital
Hills Road
Cambridge
CB2 0QQ
United Kingdom
stephen.kelleher@addenbrookes.nhs.uk

Sponsor type

Government

Website

http://www.cuh.org.uk/addenbrookes/addenbrookes_index.html

Funders

Funder type

Charity

Funder name

Diabetes UK (UK) (ref: BDA 07/0003551)

Alternative name(s)

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

Location

United Kingdom

Funder name

National Institute for Health Research (NIHR) (UK) - Post-Doctoral Fellowship (ref: PDF/08/01/036)

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

2011 results in http://www.ncbi.nlm.nih.gov/pubmed/22011408

Publication citations

  1. Results

    Murphy HR, Kumareswaran K, Elleri D, Allen JM, Caldwell K, Biagioni M, Simmons D, Dunger DB, Nodale M, Wilinska ME, Amiel SA, Hovorka R, Safety and efficacy of 24-h closed-loop insulin delivery in well-controlled pregnant women with type 1 diabetes: a randomized crossover case series., Diabetes Care, 2011, 34, 12, 2527-2529, doi: 10.2337/dc11-1430.

Additional files

Editorial Notes