Type 2 diabetes self-management using continuous glucose monitoring
| ISRCTN | ISRCTN17386990 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN17386990 |
| IRAS number | 290957 |
| Secondary identifying numbers | IRAS 290957, RIO 031-20 |
- Submission date
- 16/04/2021
- Registration date
- 22/04/2021
- Last edited
- 26/08/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nutritional, Metabolic, Endocrine
Plain English summary of protocol
Background and study aims
People living with diabetes are required to self-manage their condition through a variety of self-care activities such as eating a healthy diet, exercising regularly, taking medication, and monitoring their blood glucose levels. Individuals living with Type 2 Diabetes who receive support from specialist diabetes teams typically have complex health care needs and multiple chronic conditions for them to self-manage. This requires continuous effort and can be physically, emotionally, intellectually, and socially demanding.
Continuous glucose monitors (CGM) have been developed to give people with diabetes real-time readings of their blood glucose levels. It has been shown that using CGM can help some people with diabetes manage their blood glucose levels and improve their quality of life.
The aim of the study is to determine whether being able to see blood glucose levels using CGM for 12 weeks will help support people with complex Type 2 Diabetes to self-manage their diabetes.
Who can participate?
Adults with established Type 2 Diabetes (for over 1 year) and under the care of specialist hospital diabetes teams (Outpatients) will be invited to take part.
What does the study involve?
The study will compare the short-term use (12 weeks) of CGM on self-management behaviour compared to usual care. All participants will use a continuous glucose monitor as part of the study. Participants will be asked to attend 6 study visits over 36 weeks and will also receive 2 phone calls from the study nurse during the 12 week period that they are using the CGM device.
Participants will be allocated to recieve either CGM or usual care for 12 weeks, with an equal chance of being in either group (like tossing a coin) for the first period of the study. In the second period of the study, participants will receive the intervention that they did not receive in the first half of the study. In the third 12 week period of the study, no participants will have access to the CGM device.
Participants will wear the CGM device for 3 separate periods throughout the study. Two of the periods will last for 10 days each and during this time the participant will not be able to see their blood glucose readings. The third period will last for 12 weeks when the participant will be able to use the CGM device fully to help them self-manage their diabetes. All participants will wear the CGM device for 12 weeks followed by a period of 12 weeks when they will receive usual care and not wear the device.
Throughout the study participants will be asked to complete the following questionnaires:
1. Diabetes Self-Management Questionnaire at randomisation, 12, 24 & 36 weeks;
2. Patient Activation Measure at screening, randomisation, 12, 24 & 36 weeks;
3. Audit of Diabetes Dependent Quality of Life Questionnaire at randomisation, 12, 24 & 36 weeks;
4. Problem Areas in Diabetes (PAID-5) questionnaire at randomisation, 12, 24 & 36 weeks.
The clinical measurements of HbA1c (glycated haemoglobin, which is a marker from blood samples of how well-controlled blood sugar has been the previous few months), total cholesterol, weight, BMI, and waist circumference will also be recorded.
What are the possible benefits and risks of participating?
The aim of the study is to determine whether CGM can help support people with complex Type 2 Diabetes manage their diabetes so possible benefits of taking part in the study could include a better understanding of Type 2 Diabetes, an improvement in diabetes self-management skills, an improvement in diabetes-related quality of life, and a reduction in diabetes-related distress. There could also be an improvement in an individual's blood glucose control and other clinical outcomes such as weight, reducing their risk of developing the complications of diabetes.
However, there may be no clinical benefit to taking part in the study and the use of a continuous glucose monitor may result in some discomfort, irritation, and redness at the site where the sensor is inserted. It may also increase anxiety or diabetes-related distress by providing regular blood glucose readings. Blood samples will be taken as part of the study which may cause some discomfort or bruising, however, this does not usually cause serious problems.
Where is the study run from?
Diabetes Research Group, Swansea University (UK)
When is the study starting and how long is it expected to run for?
From May 2020 to March 2023 (updated 25/05/2022, previously: February 2023; updated 31/03/2022, previously: December 2022; updated 19/10/2021, previously: August 2022; updated 03/08/2021, previously: July 2022)
Who is funding the study?
Dexcom (USA) and Swansea University (UK)
Who is the main contact?
Dr Sharon Parsons
S.N.Parsons@Swansea.ac.uk
Contact information
Public
Diabetes Research Group
Swansea University
Grove Building
Singleton Park
Swansea
SA2 8PP
United Kingdom
 ORCID ID |
0000-0002-5841-8309 |
|---|---|
| Phone | +44 (0)1792 606721 |
| S.N.Parsons@Swansea.ac.uk |
Study information
| Study design | Single centre interventional randomized crossover trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised cross over trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details to request a participant information sheet. |
| Scientific title | A randomised, controlled crossover study of short-term use of continuous glucose monitoring (CGM) to support self-management behaviour in complex type 2 diabetes mellitus: the DISCO GM study |
| Study acronym | DISCO GM |
| Study objectives | Visualisation of blood glucose levels through the short-term use of continuous glucose monitoring alters self-management behaviour in people with complex type 2 diabetes mellitus. |
| Ethics approval(s) | Approved 12/01/2021, Wales Rec 6 (Public Health Wales, Building 1, Jobswell Road, St David's Park, SA31 3HB; +44 (0)1267 611164; Wales.REC6@Wales.nhs.uk), ref: 20/WA/0349 |
| Health condition(s) or problem(s) studied | Self-management of type 2 diabetes |
| Intervention | The study will be a randomised controlled crossover study of 36 weeks duration comparing: 1. Routine diabetes care plus diabetes self-management education 2. Short term use of Continuous Glucose Monitoring (12 weeks) plus diabetes self-management education. Following diabetes self-management education, each participant will be randomised to undertake each intervention for a period of 12 weeks, followed by a 12-week follow-up period. The treatment sequence will be allocated at random. Randomisation will be performed using a computer generated list of random study sequence. Participants will be stratified according to whether they receive insulin therapy. |
| Intervention type | Device |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Not provided at time of registration |
| Primary outcome measure | Diabetes self-management behaviour will be measured using the Diabetes Self-Management Questionnaire (DSMQ) at randomisation, 12, 24, and 36 weeks. |
| Secondary outcome measures | 1. Diabetes-related quality of life measured using the Audit of Diabetes Dependent Quality of Life (ADDQoL) questionnaire at randomisation, 12, 24, and 36 weeks 2. Diabetes related distress measured using the Problem Areas in Diabetes (PAID-5) questionnaire at randomisation, 12, 24, and 36 weeks. 3. Patient Activation Level measured using the Patient Activation Measure (PAM) at screening, randomisation, 12, 24, and 36 weeks 4. Blood glucose control measured using HbA1c at randomisation, 12, 24, and 36 weeks 5. Glucose variability, incidence of hypoglycaemia, and time in range metrics will be measured using the continuous glucose monitoring device during the 12 week period the participant wears the device 6. Clinical outcomes such as weight, BMI, waist circumference and total cholesterol will be measured at randomisation, 12, 24 and 36 weeks |
| Overall study start date | 06/05/2020 |
| Completion date | 31/03/2023 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 60 |
| Total final enrolment | 62 |
| Key inclusion criteria | 1. Aged over 18 years 2. Diagnosed with Type 2 Diabetes for over 1 year 3. Receiving care from a specialist diabetes team (hospital outpatient setting) 4. HbA1c level equal to or over 75 mmol/mol (9%) 5. Willing and able to provide informed consent 6. Willing and able to engage with continuous glucose monitoring |
| Key exclusion criteria | 1. Diabetes other than Type 2 Diabetes 2. Pregnancy 3. Participation in any investigational drug trial within one month prior to visit 1 4. Condition rendering the participant unable to understand the nature, scope, and possible consequences of the study 5. End-stage renal disease (existing or planned dialysis or transplantation) 6. Severe non-proliferative diabetic retinopathy, proliferative diabetic retinopathy, and diabetic macular oedema 7. Blindness or severe loss of visual acuity in both eyes 8. Treatment with hydroxyurea 9. Treatment with paracetamol (acetaminophen) higher than 1,000 mg every 6 h daily |
| Date of first enrolment | 21/06/2021 |
| Date of final enrolment | 30/06/2022 |
Locations
Countries of recruitment
- United Kingdom
- Wales
Study participating centre
Swansea
SA6 6NL
United Kingdom
Sponsor information
University/education
Research, Engagement & Innovation Services
Singleton Campus
Swansea
SA2 8PP
Wales
United Kingdom
| Phone | +44 (0)1792 513849 |
|---|---|
| Researchgovernance@Swansea.ac.uk | |
| Website | http://www.swansea.ac.uk/ |
"ROR" |
https://ror.org/053fq8t95 |
Funders
Funder type
Industry
Government organisation / For-profit companies (industry)
- Alternative name(s)
- Dexcom, Inc.
- Location
- United States of America
Government organisation / Universities (academic only)
- Alternative name(s)
- 斯旺西大学, Prifysgol Abertawe
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 31/12/2023 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned publication in a high impact peer-reviewed journal. |
| IPD sharing plan | The datasets generated during and/or analysed during the current study will be available upon request from Dr Sharon Parsons (S.N.Parsons@Swansea.ac.uk) once all analysis and study publications have been completed. All data shared will be anonymised and released following review of the request and agreement by the Chief Investigator and all Co-Investigators |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| HRA research summary | 28/06/2023 | No | No | ||
| Results article | 14/08/2025 | 26/08/2025 | Yes | No |
Editorial Notes
26/08/2025: Publication reference added.
25/08/2023: The following changes were made to the trial record:
1. The intention to publish date was changed from 31/08/2023 to 31/12/2023.
2. The total final enrolment was added.
25/05/2022: The following changes have been made:
1. The recruitment end date has been changed from 31/05/2022 to 30/06/2022.
2. The overall trial end date has been changed from 28/02/2023 to 31/03/2023 and the plain English summary has been updated to reflect this change.
31/03/2022: The following changes have been made:
1. The recruitment end date has been changed from 31/03/2022 to 31/05/2022.
2. The overall trial end date has been changed from 31/12/2022 to 28/02/2023 and the plain English summary has been updated to reflect this change.
19/10/2021: The following changes have been made:
1. The recruitment end date has been changed from 31/10/2021 to 31/03/2022.
2. The overall trial end date has been changed from 31/08/2022 to 31/12/2022 and the plain English summary has been updated to reflect this change.
03/08/2021: The following changes were made to the trial record:
1. The recruitment end date was changed from 31/08/2021 to 31/10/2021.
2. The overall end date was changed from 31/07/2022 to 31/08/2022.
3. The intention to publish date was changed from 31/07/2023 to 31/08/2023.
4. The recruitment start date was changed from 17/05/2021 to 21/06/2021.
5. The plain English summary was updated to reflect these changes.
20/04/2021: Trial’s existence confirmed by Wales REC 6.
