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Prevention of recurrent severe hypoglycaemia: optimised multiple daily insulin injection (MDI) versus continuous subcutaneous insulin infusion (CSII) with or without adjunctive real-time continuous glucose monitoring
ISRCTN ISRCTN52164803
DOI 10.1186/ISRCTN52164803
ClinicalTrials.gov identifier
EudraCT number 2009-015396-27
Public title Prevention of recurrent severe hypoglycaemia: optimised multiple daily insulin injection (MDI) versus continuous subcutaneous insulin infusion (CSII) with or without adjunctive real-time continuous glucose monitoring
Scientific title A definitive randomised controlled trial (RCT) comparing optimised multiple daily insulin injection (MDI) and continuous subcutaneous insulin infusion (CSII) with or without adjunctive real-time continuous glucose monitoring for the prevention of recurrent severe hypoglycaemia
Acronym hypo COMPASS
Serial number at source 5052
Study hypothesis This study asks whether, in people who have diabetes mellitus and suffer from impaired or altered awareness of low blood sugars (hypoglycaemia), it is possible to restore that awareness and therefore prevent severe hypoglycaemia by rigorously preventing the participants from having any episodes of hypoglycaemia without jeopardising their overall diabetes control and using existing technology. The study will be able to answer this by analysis of a validated quantitative questionnaire that will be used throughout the study.

Please note that as of 25/10/2012, the anticipated end date for this study was updated from 31/07/2012 to 31/08/2013.
Lay summary Background and study aims:
People with type 1 diabetes often miss early warnings of falling blood glucose level. This is a major concern as it can cause the individual to collapse without warning (severe hypoglycaemia). This problem can be reversed by preventing glucose levels falling too low, but this can be difficult as high glucose levels can also be damaging. Severe hypoglycaemia can be prevented in most people while improving overall glucose control using modern insulin injections or an insulin pump.
In this study, we plan to further test these treatments with a new glucose sensor which can detect low glucose levels. The aim of the study is to find the best way of managing and supporting all patients with hypoglycaemia in the future.

Who can participate?
Male or female participants aged between 18 and 74 years, who have type 1 diabetes mellitus and have experienced impaired hypoglycaemia awareness and have experienced an episode of severe hypoglycaemia.

What does the study involve?
The study will compare insulin pumps and multiple daily injections with or without continuous glucose monitoring. Participants are randomly allocated to receiving either multiple daily insulin injections or insulin pump therapy, with or without continuous glucose monitoring.

What are the possible benefits and risks of participating?
The education programme given is hoped to improve the participantsí overall diabetes control for many years after the end of the study. Participants with impaired awareness of hypoglycaemia may be at risk of severe hypoglycaemia. However, all the study treatments are tailored towards strict hypoglycaemia avoidance. For participants receiving insulin pump therapy may be at risk of diabetic ketoacidosis if the insulin pump is not used correctly.

Where is the study run from?
Newcastle Upon Tyne Hospitals NHS Foundation Trust

When is the study starting and how long is it expected to run for?
The study began recruiting participants in 2010, and recruitment ended in June 2011. The study will be completed in August 2013.

Who is funding the study?
Diabetes UK

Who is the main contact?
Professor James Shaw
jim.shaw@ncl.ac.uk
Ethics approval Sunderland Research Ethics Committee,18th December 2009, ref: 09/H0904/63
Study design Interventional multicentre randomised controlled trial, 2 x 2 factorial design
Countries of recruitment United Kingdom
Disease/condition/study domain Type 1 diabetes mellitus
Participants - inclusion criteria 1. Male or female patients aged 18 - 74 years
2. Established type 1 diabetes mellitus (C peptide negative)
3. Experienced impaired hypoglycaemia awareness and, or at least one episode of severe hypoglycaemia as defined as by the American Diabetes Association in the previous 12 months
4. Willing to undergo intensive insulin therapy including the use of CSII (insulin pump)
5. Willing to monitor home blood glucose levels at least four times daily
6. Willing to monitor and record signs and symptoms of hypoglycaemia
Participants - exclusion criteria 1. Not willing to consider insulin pump therapy
2. Unable to use the technology such as real time glucose monitoring
Anticipated start date 01/12/2009
Anticipated end date 31/08/2013
Status of trial Completed
Patient information material Not available in web format, please use the contact details found in the intervention section below to request a patient information sheet
Target number of participants 100 patients
Interventions All participants will participate in an educational programme which has been validated in our single centre pilot study. This includes carbohydrate counting, discussion on glycaemic indices of food, the effect of exercise on blood glucose, the importance of detection and prevention of nocturnal hypoglycaemia and recommendations on carbohydrate administration for blood glucose less then 4 mmol/l. Thereafter participants will be randomised to one of four intervention groups for the 24 week intervention period. The four groups are as follows:
1. Multiple daily subcutaneous insulin analogue injections (MDI). Insulins used will be insulin glargine and insulin aspart.
2. MDI using aspart and glargine with real time continuous glucose monitoring
3. Continuous subcutaneous insulin infusion (CSII) using insulin aspart
4. CSII using insulin aspart with real time continuous glucose monitoring

Participants will be followed up monthly during the 24 week intervention period after which they will be followed up at 6, 12 and 18 months. All diabetes care after the 24 week intervention period will return to routine NHS care.

Contact details for Patient Information Sheet:
Cath Brennand
Clinical Trial Manager
Newcastle Clinical Trials Unit
4th Floor, William Leech Building
Medical School
Framlington Place
Newcastle upon Tyne NE2 4HH
United Kingdom
Email: cath.brennand@newcastle.ac.uk
Primary outcome measure(s) Restoration of hypoglycaemia awareness as determined by quantitative questionnaire analysis.
Secondary outcome measure(s) 1. Difference in rates of mild symptomatic hypoglycaemia as measured by home blood glucose diaries at 6 months and intermediate study visits
2. Difference in duration of biochemical hypoglycaemia determined by 7-day continuous glucose monitoring system (CGMS) at 6 months and intermediate study visits
3. Difference in HbA1c at 6 months and intermediate study visits
4. Difference in rates weekly 8-point glucose profiles
Sources of funding Diabetes UK (UK) (ref: 07/0003556)
Trial website
Publications 1. 2012 results in http://www.ncbi.nlm.nih.gov/pubmed/23237320
2. 2013 results in http://www.ncbi.nlm.nih.gov/pubmed/24130355
Contact name Prof  James  Shaw
  Address Professor of Regenerative Medicine for Diabetes and Honorary Consultant Physician
Institute of Cellular Medicine
4th Floor William Leech Building
Newcastle University
Medical School
Framlington Place
  City/town Newcastle upon Tyne
  Zip/Postcode NE2 4HH
  Country United Kingdom
  Email jim.shaw@ncl.ac.uk
Sponsor Newcastle Upon Tyne Hospitals NHS Foundation Trust (UK)
  Address c/o Amanda Tortice
Research and Development
  City/town Newcastle upon Tyne
  Zip/Postcode NE14LP
  Country United Kingdom
  Tel +44 (0)191 282 5959
  Fax +44 (0)191 282 0064
  Email amanda.tortice@nuth.nhs.uk
  Sponsor website: http://www.newcastle-hospitals.org.uk/
Date applied 06/08/2009
Last edited 22/11/2013
Date ISRCTN assigned 18/09/2009
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