Closed Loop In Pregnancy: normal daily activities study
| ISRCTN | ISRCTN50385583 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN50385583 |
| Secondary identifying numbers | Version 1.2 Nov 11 2009 |
- Submission date
- 09/02/2010
- Registration date
- 06/04/2010
- Last edited
- 12/07/2013
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nutritional, Metabolic, Endocrine
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Helen R Murphy
Scientific
Scientific
Level 4 Metabolic Research Laboratories
Institute of Metabolic Science
Box 289 Addenbrookes Hospital
Hills Road
Cambridge
CB2 0QQ
United Kingdom
| Phone | +44 (0)1223 769079 |
|---|---|
| hm386@medschl.cam.ac.uk |
Study information
| Study design | Open label randomised cross-over study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| 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 |
| Study acronym | CLIP - 02 |
| Study objectives | 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(s) | Essex 2 Research Ethics Committee approved on the 9th December 2009 (ref: 09/H0302/113) |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure | 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 study start date | 01/03/2010 |
| Completion date | 28/02/2011 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Female |
| Target number of participants | 12 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 01/03/2010 |
| Date of final enrolment | 28/02/2011 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Level 4 Metabolic Research Laboratories
Cambridge
CB2 0QQ
United Kingdom
CB2 0QQ
United Kingdom
Sponsor information
Cambridge University Hospital NHS Foundation Trust (UK)
Hospital/treatment centre
Hospital/treatment centre
Addenbrookes Hospital
Hills Road
Cambridge
CB2 0QQ
England
United Kingdom
| stephen.kelleher@addenbrookes.nhs.uk | |
| Website | http://www.cuh.org.uk/addenbrookes/addenbrookes_index.html |
"ROR" |
https://ror.org/04v54gj93 |
Funders
Funder type
Charity
Diabetes UK (UK) (ref: BDA 07/0003551)
Private sector organisation / Trusts, charities, foundations (both public and private)
Private sector organisation / Trusts, charities, foundations (both public and private)
- Alternative name(s)
- DIABETES UK LIMITED, British Diabetic Association
- Location
- United Kingdom
National Institute for Health Research (NIHR) (UK) - Post-Doctoral Fellowship (ref: PDF/08/01/036)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/12/2011 | Yes | No |
