Closed Loop In Pregnancy: normal daily activities study
| ISRCTN | ISRCTN50385583 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN50385583 |
| Protocol serial number | Version 1.2 Nov 11 2009 |
| Sponsor | Cambridge University Hospital NHS Foundation Trust (UK) |
| Funders | Diabetes UK (UK) (ref: BDA 07/0003551), National Institute for Health Research (NIHR) (UK) - Post-Doctoral Fellowship (ref: PDF/08/01/036) |
- 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
| Primary study design | Interventional |
|---|---|
| Study design | Open label randomised cross-over study |
| Secondary study design | Randomised controlled trial |
| Study type | Participant 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(s) |
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). |
| Key secondary outcome measure(s) |
1. Total daily dose of insulin (TDD) on intervention versus control visit |
| Completion date | 28/02/2011 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Female |
| Target sample size at registration | 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
- United Kingdom
- England
Study participating centre
Level 4 Metabolic Research Laboratories
Cambridge
CB2 0QQ
United Kingdom
CB2 0QQ
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | 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 | |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
