Intensive blood glucose control for chronic obstructive pulmonary disease (COPD) patients on acute medical wards
| ISRCTN | ISRCTN42412334 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN42412334 |
| ClinicalTrials.gov number | NCT00764556 |
| Secondary identifying numbers | SGH-ClinPharm-1 |
- Submission date
- 01/10/2008
- Registration date
- 20/11/2008
- Last edited
- 26/10/2011
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Respiratory
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Emma Baker
Scientific
Scientific
Centre for Clinical Pharmacology
Room 66, Ground Floor Jenner Wing
St George's, University of London
Cranmer Terrace
London
SW17 0RE
United Kingdom
| Phone | +44 (0)20 8725 5383 |
|---|---|
| ebaker@sgul.ac.uk |
Study information
| Study design | Prospective, non-randomised, phase II study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non 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 | Phase II study: investigation of the safety and efficacy of a protocol for tight glycaemic control in patients with chronic obstructive pulmonary disease (COPD) exacerbations admitted to an acute medical unit |
| Study acronym | IPS 2008 |
| Study objectives | This study will test the safety and feasibility of tight control of blood glucose with insulin in patients with acute exacerbations of COPD outside the intensive care setting in acute medical wards. |
| Ethics approval(s) | Joint UCL/UCLH Ethics Committee gave approval in early 2008 (ref: 07/H0715/93) |
| Health condition(s) or problem(s) studied | Acute exacerbation of chronic obstructive pulmonary disease (AECOPD) |
| Intervention | This is a single arm trial. Patients receive insulin with the aim of controlling blood glucose to a target of 4.4 - 6.5 mM. Insulin is initially intravenous (actrapid), then subcutaneous (glargine or detemir plus aspart). Patients receive insulin throughout hospital admission and is stopped on discharge. Follow up is during hospital stay; there is no follow up after discharge for the study. |
| Intervention type | Other |
| Primary outcome measure | The frequency of severe hypoglycaemia - neuroglycopaenic symptoms (other than mild agitation) responsive to administration of carbohydrate. The outcomes are measured/looked for continuously during treatment/hospital stay. |
| Secondary outcome measures | 1. The frequency of symptomatic hypoglycaemia (capillary glucose less than or equal to 3.3 mM and symptoms consistent with hypoglycaemia) 2. The frequency of asymptomatic hypoglycaemia (capillary glucose less than or equal to 3.3 mM without any symptoms consistent with hypoglycaemia) 3. Mean 24 hour capillary glucose concentrations 4. Proportion of capillary glucose measurements in target range (4.4 - 6.5 mM) 5. Comparison of capillary blood glucose measurements to those obtained from the Guardian REAL®-time continuous glucose monitoring system 6. Comparison of rates of detection of hypoglycaemia by capillary and continuous blood glucose monitoring 7. Quantification of acceptability of the study intervention to patients The outcomes are measured/looked for continuously during treatment/hospital stay. |
| Overall study start date | 01/05/2008 |
| Completion date | 01/05/2009 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 20 |
| Key inclusion criteria | 1. Physician diagnosis of acute exacerbation of chronic obstructive pulmonary disease (AECOPD) as primary cause for admission 2. Able to enter study within 24 hours of admission 3. Age greater than 40 years, male and female |
| Key exclusion criteria | 1. Intensive care unit admission 2. Moribund or not for active treatment 3. Admission expected to last less than 48 hours 4. Unable or unwilling to give informed consent 5. Known type I diabetes mellitus 6. Patients with reduced awareness of hypoglycaemia including reduced Glasgow Coma Scale or those taking beta blockers 6. Patients with renal or hepatic failure at increased risk of hypoglycaemia |
| Date of first enrolment | 01/05/2008 |
| Date of final enrolment | 01/05/2009 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Centre for Clinical Pharmacology
London
SW17 0RE
United Kingdom
SW17 0RE
United Kingdom
Sponsor information
St George's, University of London (UK)
University/education
University/education
Cranmer Terrace
London
SW17 0RE
England
United Kingdom
| Website | http://www.sgul.ac.uk/ |
|---|---|
"ROR" |
https://ror.org/040f08y74 |
Funders
Funder type
Government
National Institute for Health Research (NIHR) (UK) - NIHR Trainees Programme funds academic clinical fellows
No information available
Own consumables
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 | 23/07/2011 | Yes | No |
