Condition category
Nutritional, Metabolic, Endocrine
Date applied
16/04/2014
Date assigned
15/05/2014
Last edited
02/06/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
For people with diabetes monitoring the level of glucose in the blood is an important part of managing their condition. Self-monitoring of blood glucose (SMBG) involves a person with diabetes monitoring their own blood glucose levels using a blood glucose meter. SMBG has been widely accepted as essential for people with type 1 and type 2 diabetes who have insulin injections for their diabetes, as the information gained from the monitoring can help decide the insulin dose required and prevent blood glucose levels from going too low. It can also help the person with diabetes adjust their diet and exercise to better control their blood glucose levels. However, for people with diabetes who do not take insulin and manage their diabetes by taking tablets or through diet and exercise alone, there is a continuing debate regarding the benefit of SMBG. People with type 2 diabetes have their blood glucose level measured at least annually by their GP. It is measured in terms of their Haemoglobin A1c level (or HbA1c). If HbA1c levels are too high, various anti-diabetic medications may be prescribed. Previous studies have not shown consistently that there is an improvement in patients’ HbA1c levels when they have used SMBG compared to those who haven't. However, it has not always been clear how the patients were monitoring, what action they took as a result of their blood glucose readings and what action their health care professional (GP, diabetes doctor, nurse) took. Without either the patient or health care professional taking any action, it has been shown that SMBG alone will not make a difference. This study will therefore look at whether there is a difference in HbA1c levels after 12 months in patients with type 2 diabetes who use SMBG compared to those who do not, when diabetes education and SMBG training is given to patients. Health care professionals will also be encouraged to take action to adjust medication based on the regular blood glucose readings as opposed to the HbA1c results. The study will also look at how much support needs to be given to patients using SMBG by providing some patients with additional monthly advice and support from a study nurse.

What does the study involve?
People aged between 18 and 80 with type 2 diabetes who are not currently treated with insulin will be invited to take part in the study.

What does the study involve?
Those who take part in the study will be asked to visit their nearest research clinic (this will be their GP practice or local hospital) every 3 months over a 12-month period. They will be randomly allocated to one of three groups. Group 1 will not monitor their blood glucose. Group 2 will monitor their blood glucose (SMBG group). Group 3 will monitor their blood glucose and will also discuss their readings with the study nurse by phone each month and action will be taken where needed (SMBG with telecare group). Participants allocated to the SMBG groups will be asked to attend training so that they can be taught how to use the blood glucose meters. In total, patients in all groups may be asked to attend the clinic up to seven times over the course of the year with each visit lasting between 20 minutes to 1 hour. They will see their GP and other health care professional as normal and will also attend the research clinic every 3 months for some basic clinical measurements to be taken such as HbA1c and cholesterol levels. At the research centre visits they will complete some questionnaires asking about their general well-being and their diabetes.

What are the possible benefits and risks of participating?
Those who take part in the study may benefit from better control of their blood glucose and more appropriate treatment for their diabetes. There are no risks to taking part in the study as patients will be receiving standard care as they should be receiving now. The only difference being that treatment may be more targeted or intensified in patients allocated to the SMBG groups, but this remains to be seen.

Where is the study run from?
15 sites in the UK (see below).

When is the study starting and how long is it expected to run for?
The study started in December 2012 and is expected to run until June 2016.

Who is funding the study?
European Foundation for the Study of Diabetes (EFSD) (Germany).

Who is the main contact?
Sharon Parsons
S.N.Parsons@swansea.ac.uk

Trial website

Contact information

Type

Scientific

Primary contact

Ms Sharon Parsons

ORCID ID

Contact details

Singleton Park
Swansea
SA2 8PP
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

12038

Study information

Scientific title

Self-monitoring of blood glucose (SMBG): a randomised controlled trial comparing no SMBG, SMBG alone and SMBG with telecare

Acronym

SMBG

Study hypothesis

To determine whether HbA1c is significantly altered at 12 months in patients who receive SMBG compared to the control group.

Ethics approval

South East Wales REC panel C, 07/02/2011, 10/WSE03/50

Study design

Randomised; Interventional; Design type: Process of Care

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Topic: Diabetes; Subtopic: Type 2; Disease: Diabetic Control

Intervention

Participants will be randomised into one of the following three groups:

Group 1: no self monitoring of blood glucose (SMBG), usual diabetes care, general diabetes education via booklet, research clinic visits every 3 months for 12 months

Group 2: SMBG with self adjustment, usual diabetes care, general diabetes education via booklet, SMBG training using Accu-Chek 360° and pattern recognition, use of patient algorithm for self-management adjustment, agreed goal setting/care plan using SMBG readings* at research clinic visits every 3 months for 12 months, refresher training on SMBG at each research clinic visit

Group 3: SMBG with telecare, usual diabetes care, general diabetes education via booklet, SMBG training using Accu-Chek 360° and pattern recognition, use of patient algorithm for self-management adjustment, agreed goal setting/care plan using SMBG readings* at monthly intervals over the phone and research clinic visits every 3 months for 12 months, refresher training on SMBG at each research clinic visit

*4-point blood glucose profile to be taken 2 days every week (1 day during the week, 1 day during the weekend). 7-point profile to be taken for 3 days the week before the research clinic visit. Results uploaded to study nurse for review as part of care plan.

Patient follow-up is for 12 months in all patient groups.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

HbA1c result; Timepoint(s): at 12 months

Secondary outcome measures

Not provided at time of registration

Overall trial start date

04/12/2012

Overall trial end date

30/09/2016

Reason abandoned

Eligibility

Participant inclusion criteria

1. Type 2 diabetes mellitus patients with a duration of diabetes > 1 year
2. Age 18-80 years
3. HbA1c levels between ≥7.5% and ≤13%
4. Willing and able to provide informed consent
5. Access to a telephone
6. Able to make blood glucose measurements
Target Gender: Male & Female; Upper Age Limit 80 years ; Lower Age Limit 18 years

Participant type

Patient

Age group

Other

Gender

Both

Target number of participants

Planned Sample Size: 850; UK Sample Size: 850

Participant exclusion criteria

1. Diabetes other than type 2 diabetes mellitus (e.g., GAD positive) or treated with insulin
2. Pregnancy
3. Gestational diabetes mellitus
4. Severe chronic hepatic disease
5. Need to use SMBG as part of clinical care
6. Participation in any investigational drug trial within 1 month prior to Visit 1
7. Mental condition rendering the subject unable to understand the nature, scope and possible consequences of the study
8. End-stage renal disease (existing or planned dialysis or transplantation) or creatinine >150 umol/L
9. Blindness or severe loss of visual acuity in both eyes

Recruitment start date

04/12/2012

Recruitment end date

30/06/2015

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Joint Clinical Research Facility
ILS2 Swansea University
Swansea
SA2 8PP
United Kingdom

Trial participating centre

Wrexham Maelor Hospital
Wrexham
-
United Kingdom

Trial participating centre

St Thomas & West Cross Surgeries
Swansea
-
United Kingdom

Trial participating centre

Diabetes Centre
Glangwili Hospital
Carmarthen
-
United Kingdom

Trial participating centre

Bellevue Practice
Newport
-
United Kingdom

Trial participating centre

Clinical Research Centre
Prince Philip Hospital
Llanelli
-
United Kingdom

Trial participating centre

Sketty & Killay Surgeries
Swansea
-
United Kingdom

Trial participating centre

Withybush Hospital
Haverfordwest
-
United Kingdom

Trial participating centre

Castle Surgery
Neath
-
United Kingdom

Trial participating centre

Clarence Medical Centre
Rhyl
-
United Kingdom

Trial participating centre

The Practice of Health
Barry
-
United Kingdom

Trial participating centre

Llandaff North Medical Centre
Cardiff
-
United Kingdom

Trial participating centre

Countess of Chester Hospital
Chester
-
United Kingdom

Trial participating centre

Oakenhurst Medical Centre
Blackburn
-
United Kingdom

Trial participating centre

Ystradgynlais Group Practice
Ystradgynlais
-
United Kingdom

Sponsor information

Organisation

Abertawe Bro Morgannwg University Health Board (UK)

Sponsor details

One Talbot Gateway
Baglan Energy Park
Seaway Parade
Port Talbot
SA12 7BR
United Kingdom
-
abm.rd@wales.nhs.uk

Sponsor type

Hospital/treatment centre

Website

http://www.abm.wales.nhs.uk/

Funders

Funder type

Research organisation

Funder name

European Foundation for the Study of Diabetes (Germany)

Alternative name(s)

EFSD

Funding Body Type

private sector organisation

Funding Body Subtype

foundation

Location

Germany

Funder name

Roche Diagnostics GmbH (Switzerland)

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

02/06/2016: the overall trial end date was changed from 01/06/2016 to 30/09/2016. 22/04/2015: the overall trial end date was changed from 31/12/2014 to 01/06/2016.