Self-monitoring of blood glucose (SMBG): comparison of no SMBG, SMBG alone and SMBG with telecare
| ISRCTN | ISRCTN21390608 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN21390608 |
| Secondary identifying numbers | 12038 |
- Submission date
- 16/04/2014
- Registration date
- 15/05/2014
- Last edited
- 07/10/2020
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nutritional, Metabolic, Endocrine
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
Contact information
Scientific
Singleton Park
Swansea
SA2 8PP
United Kingdom
Study information
| Study design | Randomised; Interventional; Design type: Process of Care |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Other |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | Self-monitoring of blood glucose (SMBG): a randomised controlled trial comparing no SMBG, SMBG alone and SMBG with telecare |
| Study 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(s) | South East Wales REC panel C, 07/02/2011, 10/WSE03/50 |
| 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 |
| Primary outcome measure | HbA1c result; Timepoint(s): at 12 months |
| Secondary outcome measures | Not provided at time of registration |
| Overall study start date | 04/12/2012 |
| Overall study end date | 30/09/2016 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Other |
| Lower age limit | 18 Years |
| Upper age limit | 80 Years |
| Sex | Both |
| Target number of participants | Planned Sample Size: 850; UK Sample Size: 850 |
| Total final enrolment | 446 |
| 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 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
- Wales
Study participating centres
Swansea University
Swansea
SA2 8PP
United Kingdom
-
United Kingdom
-
United Kingdom
Carmarthen
-
United Kingdom
-
United Kingdom
Llanelli
-
United Kingdom
-
United Kingdom
-
United Kingdom
-
United Kingdom
-
United Kingdom
-
United Kingdom
-
United Kingdom
-
United Kingdom
-
United Kingdom
-
United Kingdom
Sponsor information
Hospital/treatment centre
One Talbot Gateway
Baglan Energy Park
Seaway Parade
Port Talbot
SA12 7BR
Wales
United Kingdom
| abm.rd@wales.nhs.uk | |
| Website | http://www.abm.wales.nhs.uk/ |
"ROR" |
https://ror.org/04zet5t12 |
Funders
Funder type
Research organisation
Private sector organisation / Trusts, charities, foundations (both public and private)
- Alternative name(s)
- The European Association for the Study of Diabetes, EFSD
- Location
- Germany
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are available upon request from Dr Sharon Parsons (S.N.Parsons@Swansea.ac.uk) once all analyses and publications have been completed. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | protocol | 26/01/2017 | Yes | No | |
| Results article | results | 01/05/2019 | 28/09/2020 | Yes | No |
Editorial Notes
07/10/2020: The total final enrolment number was corrected from 323 to 446.
06/10/2020: IPD sharing statement added.
28/09/2020: Publication reference and total final enrolment number added.
02/02/2017: Publication reference added.
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.
