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 (NCT)	NCT00764556
Protocol serial number	SGH-ClinPharm-1
Sponsor	St George's, University of London (UK)
Funders	National Institute for Health Research (NIHR) (UK) - NIHR Trainees Programme funds academic clinical fellows, Own consumables

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

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
Email	ebaker@sgul.ac.uk

Study information

Primary study design	Interventional
Study design	Prospective, non-randomised, phase II study
Secondary study design	Non randomised controlled trial
Study type	Participant 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(s)	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.
Key secondary outcome measure(s)	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.
Completion date	01/05/2009

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	All
Target sample size at registration	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

United Kingdom
England

Study participating centre

Centre for Clinical Pharmacology

London
SW17 0RE
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	23/07/2011		Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes