Plain English 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 participants' 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
Trial website
Contact information
Type
Scientific
Primary contact
Prof James Shaw
ORCID ID
Contact details
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
Newcastle upon Tyne
NE2 4HH
United Kingdom
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jim.shaw@ncl.ac.uk
Additional identifiers
EudraCT number
2009-015396-27
ClinicalTrials.gov number
Protocol/serial number
5052
Study information
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
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.
Ethics approval
Sunderland Research Ethics Committee,18/12/2009, ref: 09/H0904/63
Study design
Interventional multicentre randomised controlled trial, 2 x 2 factorial design
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details found in the intervention section below to request a patient information sheet
Condition
Type 1 diabetes mellitus
Intervention
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
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measure
Restoration of hypoglycaemia awareness as determined by quantitative questionnaire analysis.
Secondary outcome measures
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
Overall trial start date
01/12/2009
Overall trial end date
31/08/2013
Reason abandoned (if study stopped)
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
100 patients
Participant exclusion criteria
1. Not willing to consider insulin pump therapy
2. Unable to use the technology such as real time glucose monitoring
Recruitment start date
01/01/2010
Recruitment end date
01/06/2011
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Institute of Cellular Medicine
Newcastle upon Tyne
NE2 4HH
United Kingdom
Sponsor information
Organisation
Newcastle Upon Tyne Hospitals NHS Foundation Trust (UK)
Sponsor details
c/o Amanda Tortice
Research and Development
Newcastle upon Tyne
NE14LP
United Kingdom
+44 (0)191 282 5959
amanda.tortice@nuth.nhs.uk
Sponsor type
Government
Website
Funders
Funder type
Charity
Funder name
Diabetes UK (UK) (ref: 07/0003556)
Alternative name(s)
Funding Body Type
private sector organisation
Funding Body Subtype
other non-profit
Location
United Kingdom
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
2018 results in: https://www.ncbi.nlm.nih.gov/pubmed/29661916
2013 results in: http://www.ncbi.nlm.nih.gov/pubmed/24130355
2012 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/23237320
Publication citations
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Results
Little S, Chadwick T, Choudhary P, Brennand C, Stickland J, Barendse S, Olateju T, Leelarathna L, Walkinshaw E, Tan HK, Marshall SM, Thomas RM, Heller S, Evans M, Kerr D, Flanagan D, Speight J, Shaw JA, Comparison of Optimised MDI versus Pumps with or without Sensors in Severe Hypoglycaemia (the Hypo COMPaSS trial)., BMC Endocr Disord, 2012, 12, 33, doi: 10.1186/1472-6823-12-33.
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Results
Leelarathna L, Little SA, Walkinshaw E, Tan HK, Lubina-Solomon A, Kumareswaran K, Lane AP, Chadwick T, Marshall SM, Speight J, Flanagan D, Heller SR, Shaw JA, Evans ML, Restoration of self-awareness of hypoglycemia in adults with long-standing type 1 diabetes: hyperinsulinemic-hypoglycemic clamp substudy results from the HypoCOMPaSS trial., Diabetes Care, 2013, 36, 12, 4063-4070, doi: 10.2337/dc13-1004.