Plain English Summary
Background and study aims
Blood glucose levels obtained by self monitoring are the main source of information on which changes in management and behaviour designed to improve diabetes control are based. However, these decisions, for practical reasons, often use only a very limited sample of the potential data available. An increasing number of devices are being marketed to convert all available data into a clinically useful form. DIASEND is one such device, enabling blood glucose data to be uploaded from most meters to a website, where it is analysed and presented in various ways to give maximum clinical benefit. Both the patient and a healthcare advisor, with permission, can access the same information simultaneously from different sites in order to enrich discussion. The study aims to demonstrate that the use of this enhanced information by diabetes specialist nurses (DSNs) confers benefit to patients both in terms of improved blood glucose control and in confidence to self-manage.
Who can participate?
The Diasend Study aims to recruit 294 people with poorly-controlled (HbA1c between 58 and 97 mmol/mol) type 1 and insulin-treated type 2 diabetes over the age of 21 years.
What does the study involve?
Over the six months of the study, participants will have a 2-3 weekly consultation, either face-to-face or over the telephone, with a diabetes specialist nurse, with the aim of improving their diabetes control. At the beginning of the study, people will be randomly allocated either to the Diasend or the usual care group. At each contact with a diabetes nurse, the usual care group will discuss their diabetes control and any changes in management using blood glucose readings stored in the blood glucose meter and/or recorded in a monitoring book. The Diasend group will upload their blood glucose readings each week from their meters memory to a secure, encrypted website using special software. The uploaded information can be displayed on screen in a number of ways, making it easier to analyse problems or detect trends. With the permission of the patient and the necessary password, the diabetes nurse can access the website, either with the patient in the clinic or remotely, and use the information to help in understanding the reasons for poor diabetes control and discuss how they might be tackled.
Participants will fill in a short questionnaire at the beginning and end of the study to assess their confidence in self-management and will have a blood test at the beginning, middle and end of the study. They will also be required to monitor their blood glucose levels at least twice daily. Other aspects of care will be as normal.
What are the possible benefits and risks of participating?
It is hoped that both groups will benefit from regular diabetes specialist nurse advice over the 6 months of the study, but that there will be a greater improvement in control and confidence in self-management and less use of resources in the Diasend group. There are no obvious risks to participation.
Where is the study run from?
Fieldhead Hospital
When is study starting and how long is it expected to run for?
It is anticipated that the study will begin in early 2013 and run for approximately a year to eighteen months.
Who is funding the study?
Funding is being applied for through Research for Patient Benefit.
Who is the main contact?
Dr Keith Sands
keith.sands@swyt.nhs.uk
Trial website
Contact information
Type
Scientific
Primary contact
Dr Keith Sands
ORCID ID
Contact details
Medical Directorate
Kendray Hospital
Doncaster Road
Barnsley
S70 3RD
United Kingdom
+44 (0)1226 434050
keith.sands@swyt.nhs.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
A randomised trial comparing the outcomes of specialist diabetes nurse advice to patients with insulin-treated diabetes and Diasend, a telehealth system, at home with a matched group of patients receiving advice based on a conventional, clinic-based approach
Acronym
Study hypothesis
The use of the Diasend system as part of normal care results in improved outcomes in terms of blood glucose control, use of resources and patient confidence in self-management.
Ethics approval
Not provided at time of registration
Study design
Open randomised possibly multi-site trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Quality of life
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Diabetes mellitus
Intervention
Diasend or the usual care group.
The study will involve 294 people of either sex with poorly controlled type 1 or insulin-treated type 2 diabetes. It will use the widely-used and validated Diabetes Treatment Satisfaction Questionnaires, administered at the beginning and end of the six month study period.
Patients will have study contact with their diabetes specialist nurse (DNS) fortnightly until the End of Study visit at 24 weeks. Contact may be face-to-face or by telephone, as determined by the DNS.
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measure
Change in HbA1c between first contact and the end of the study
Secondary outcome measures
1. Use of resources
2. Patient confidence in self-management
Overall trial start date
01/02/2013
Overall trial end date
01/08/2014
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Type 1 (not receiving insulin via a pump) or insulin-treated type 2 diabetes with an HbA1c (documented within the previous 3 months) of between 7.5% (58 mmol/mol) and 11.0% (97 mmol/mol)
2. Aged 21 years or more
3. Duration of diabetes of at least 2 years
4. BMI <40 kg/m2
5. In patients with insulin-treated type 2 diabetes, oral medication (ie no changes in dosage) must have been stable for at least 6 weeks
6. Able to attend clinic and be available for telephone consultations at the requisite times
7. Able and willing to perform blood glucose monitoring using a blood glucose meter at least twice every other day and, ideally, four times daily
8. Appropriate equipment at home to upload blood glucose levels to the Diasend web-site using the Diasend uploader
9. Willing to monitor and record signs and symptoms of hypoglycaemia
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
294
Participant exclusion criteria
1. Type 1 diabetes receiving insulin via a pump
2. Treatment with a glucagon-like peptide-1 (GLP-1) receptor agonist
3. Pregnancy
4. Disruption of liver (ALT and/or AST greater than three times the upper limit of normal at screening) or kidney (eGFR less than 50 mls/min/1.72m^2) function that might affect insulin action
5. Clinically relevant cardiovascular, respiratory, hepatic, neurological, endocrine or other major disease making implementation of the protocol or interpretation of the study results difficult
6. Any condition that, in the investigators judgement, is likely to cause the patient to be unable to understand the information in the Patient Information Sheet or provide informed consent or to cooperate fully with the protocol
7. History of drug or alcohol abuse
Recruitment start date
01/02/2013
Recruitment end date
01/08/2014
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Medical Directorate
Barnsley
S70 3RD
United Kingdom
Sponsor information
Organisation
South West Yorkshire Partnership NHS Foundation Trust (UK)
Sponsor details
c/o Dr N H Booya
Medical Director
Fieldhead Hospital
Ouchthorpe Lane
Wakefield
WF1 3SP
United Kingdom
+44 (0)1924 327000
nisreen.booya@swyt.nhs.uk
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Government
Funder name
National Institute for Health Research (NIHR) (UK) - Research for Patient Benefit Programme
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
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