Characterisation of sensor accuracy performance for Continuous Glucose Monitoring (CGM) systems
| ISRCTN | ISRCTN30194092 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN30194092 |
| IRAS number | 355902 |
- Submission date
- 19/05/2025
- Registration date
- 28/05/2025
- Last edited
- 27/05/2025
- Recruitment status
- Recruiting
- Overall study status
- Ongoing
- Condition category
- Nutritional, Metabolic, Endocrine
Plain English summary of protocol
Background and study aim
The purpose of this study is to characterize the accuracy performance of different CE-marked CGM.
Who can participate?
Anyone aged 18 years or older with type 1or type 2 diabetes.
What does the study involve?
During this study adult subjects with Type 1 or Type 2 diabetes will wear up to three sensors for a period of up to 31 days depending on each sensor's indications.
During the period of sensor wear participants will go about their normal daily activities while wearing the sensors. Participants will be asked to perform at least four Blood Glucose fingerprick tests per day (before meals and bedtime).
What are the possible benefits and risks of participating?
The data collected in this study could contribute to increase the understanding of available devices to monitor glucose for people living with diabetes as well as giving more people the opportunity to experience the use of CGM devices.
There are small risks associated with use of any sensor device that punctures and adheres to the skin, these include erythema, oedema, rash, itching, bruising, pain, bleeding, induration and infection.
The study participants will perform blood glucose tests. Risks are small but could include pain, bruising, local infection and fainting caused by the lancet used to obtain a blood sample.
Where is the study run from?
The study is run by 2 sites in UK, MAC Clinical Research Glasgow and MAC Clinical Research Barnsley.
When is the study starting and how long is it expected to run for?
June 2024 to April 2035.
Who is funding the study?
The study is funded by Abbott Diabetes Care Ltd (UK).
Who is the main contact?
Dr Pamela Reid, pamela.reid@abbott.com
Contact information
Public, Scientific
Range Road
Witney
OX29 0YL
United Kingdom
| Phone | +44 1993 863024 |
|---|---|
| pamela.reid@abbott.com |
Principal Investigator
Phoenix House, Maple Road
Tankersley
S75 3DL
United Kingdom
| Phone | +44 (0) 1226 356940 |
|---|---|
| ivelintrifonov@macplc.com |
Study information
| Study design | Post-market single arm prospective study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised study |
| Study setting(s) | Other |
| Study type | Other |
| Participant information sheet | No participant information sheet available |
| Scientific title | Characterisation of sensor accuracy performance for CGM systems |
| Study objectives | The study aims to characterise the performance and collect safety data of different Continuous Glucose Monitoring (CGM) systems in people living with diabetes. Results will be characterised in terms of point accuracy of each CGM system with respect to capillary fingerstick blood glucose values. |
| Ethics approval(s) |
Approved 16/04/2025, Yorkshire & The Humber - Leeds West Research Ethics Committee (NHSBT Newcastle Blood Donor Centre Holland Drive, Newcastle upon Tyne, NE2 4NQ, United Kingdom; +44 207 972 25 04; leedswest.rec@hra.nhs.uk), ref: 25/YH/0073 |
| Health condition(s) or problem(s) studied | Diabetes mellitus |
| Intervention | Each study arm will involve the use of CE-marked Continuous Glucose Monitoring (CGM) systems. Adults with Type 1 or Type 2 diabetes will wear between one and three sensors for a period of up to 31 days depending on each sensor's wear indications. During the period of sensor wear participants will go about their daily activities and will be asked to perform at least four Blood Glucose (BG) fingerprick tests per day. At Visit 2, sensors are removed, and adverse events are documented, if any. |
| Intervention type | Device |
| Pharmaceutical study type(s) | Not Applicable |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | CE-marked Continuous Glucose Monitoring (CGM) Systems |
| Primary outcome measure | The proportion of system readings that are within ±20% for glucose levels ≥70 mg/dL and within ±20 mg/dL for glucose levels <70 mg/dL compared to capillary fingerstick blood glucose (BG) values, over the duration of sensor wear |
| Secondary outcome measures | Safety outcomes (AEs/ DIs) will be recorded, over the duration of sensor wear |
| Overall study start date | 19/06/2024 |
| Completion date | 13/04/2035 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | Up to 450 participants per year will be enrolled. |
| Key inclusion criteria | 1. Aged at least 18 years old. 2. Have type 1 or type 2 diabetes. 3. Is willing to provide a minimum of 4 and no more than 12 capillary fingerprick blood samples for each day of sensor wear. 4. Is able to read and understand English. 5. In the investigator’s opinion, the participant is willing to wear the sensor(s), to follow the instructions provided to him/her by the study site and perform all study tasks as specified by the protocol. 6. Agrees to continue using their current method of glucose monitoring for duration of study. |
| Key exclusion criteria | 1. Has participated in the same study event. 2. Is a member of the study staff. 3. Is pregnant, planning to become pregnant within the study event duration, or becomes pregnant during the study. 4. Has known (or suspected) allergy to medical grade adhesive at enrolment. 5. Has a skin abnormality at the application sites. 6. Is currently participating in another clinical study that could affect their glucose management. 7. Has a known concomitant medical condition which, in the opinion of the investigator, could present a risk to the safety or welfare of the participant or study staff. 8. Has a pacemaker or any other neurostimulators. 9. Is unsuitable for participation due to any other cause as determined by the investigator. |
| Date of first enrolment | 19/05/2025 |
| Date of final enrolment | 01/04/2035 |
Locations
Countries of recruitment
- England
- Scotland
- United Kingdom
Study participating centres
Glasgow
G20 0XA
United Kingdom
Maple Road
Barnsley
S75 3DL
United Kingdom
Sponsor information
Industry
Range Road
Witney
OX29 0YL
England
United Kingdom
| Phone | +44 1993 863164 |
|---|---|
| pamela.reid@abbott.com |
Funders
Funder type
Industry
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not expected to be made available |
| Publication and dissemination plan | Planned publication in a peer-reviewed journal |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are not expected to be made available due to the fact the individual participant data is already available to participant and HCP on study completion. |
Editorial Notes
19/05/2025: Trial's existence confirmed by Yorkshire & The Humber - Leeds West Research Ethics Committee.
