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Contact the study team using the details below to take part. If there are no contact details below please ask your doctor in the first instance.

Contact Information:

Mr Trivart Shetty
trivart.shetty@dexcom.com


Dr Samuel Seidu
sis11@leicester.ac.uk


Study Location:

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Be Part of Research - Trial Details - Initiation and management of DExcom continuous glucose monitoring in primary care in people living with type 2 diabetes on insulin

Initiation and management of DExcom continuous glucose monitoring in primary care in people living with type 2 diabetes on insulin

Recruiting

Open to: All Genders

Age: Mixed

Medical Conditions

Type 2 Diabetes Mellitus


This information is provided directly by researchers, and we recognise that it isn't always easy to understand. We are working with researchers to improve the accessibility of this information. In some summaries, you may come across links to external websites. These websites will have more information to help you better understand the study.


People living with type 2 diabetes need to manage their blood sugar levels carefully to reduce the risk of long‑term complications such as heart disease, kidney problems, vision loss, and nerve damage. Many people currently check their blood sugar using finger‑prick tests. Continuous Glucose Monitoring (CGM) systems offer an alternative approach by measuring glucose levels continuously through a small sensor worn on the body.
This study aims to evaluate the use of the Dexcom ONE+ Continuous Glucose Monitoring system in routine primary care settings in the United Kingdom and the Republic of Ireland. The Dexcom ONE+ system is already approved for use in the UK and is CE marked. The study will assess whether using CGM helps improve blood sugar control, increases satisfaction for both participants and healthcare professionals, and can be easily integrated into everyday clinical care without disrupting usual practice.

Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.  

The recruitment start and end dates are as follows:

12 Mar 2026 31 Jan 2027

Participants will take part in the study for approximately 24 weeks.
At the beginning, study staff will check eligibility during an in‑person visit. Participants will first wear a blinded CGM sensor for around 10 days, which collects glucose information that is not visible to them. After this, participants will use an unblinded CGM system for 24 weeks, allowing them to see their glucose readings in real time. Sensors are replaced approximately every 10.5 days.
Participants will be asked to complete several short questionnaires about their diabetes care, general health, and day‑to‑day experiences. Some participants may also be invited to take part in a short interview about their experience of using the CGM system. Interviews may be carried out remotely or in person and will be audio‑recorded, transcribed, and handled confidentially.
A small amount of blood will also be collected during the study for routine testing.

Participants can contact the study doctor or local study team for any questions about the study, to report a study‑related issue, or to obtain further information. Full contact details are provided in the Participant Information Sheet.


Adults aged 18 years or older, including people who:
Have been diagnosed with type 2 diabetes for at least three months
Are currently using insulin, either alone or with other diabetes medications
Receive most of their diabetes care in a primary care (general practice) setting
Have a recent HbA1c result greater than 64 mmol/mol

You can take part if:



You may not be able to take part if:


1. Diagnosis of type 1 diabetes. 2. Any surgical procedure for weight loss within the year prior to enrolment or plans for undergoing such bariatric surgery during the study. 3. Concomitant disease or condition that in the opinion of the investigator may compromise participant safety, including but not limited to; cystic fibrosis, severe mental illness, a diagnosed or suspected eating disorder or any uncontrolled long term medical condition that would interfere with study related tasks or visits. 4. Use of medications known to exacerbate hyperglycaemia (current or for more than 14 days in the past 3 months), corticosteroids (oral and injectable) or certain psychotropics (antipsychotics, e.g., clozapine, olanzapine, risperidone, and quetiapine). 5. Breastfeeding. 6. Anticipated acute uses of glucocorticoids (oral, injectable, or IV), that will affect glycaemic control and impact HbA1c.7. Presence of a haemoglobinopathy or other condition that is expected to affect the measurement of HbA1c in the judgment of the investigator. 8. The participant, immediate family member(s), and/or person(s) living within the household work for Dexcom, Medtronic, Ypsomed, SiBionics, Glysens Inc., Abbott Laboratories, Roche, Senseonics, Waveform, Ascensia Diabetes Care, Yuwell, i-SENS, Bionime, POCTech, or Insulet and any other diabetes company; immediate relation to study staff. 9. Current participation in another interventional study protocol or prior participation in an interventional study protocol in which the participant received active drug within the 90 days prior to screening. Note: Participants will not be excluded if enrolled in another observational trial, wherein the participant is in the follow-up phase and no tests/procedures impacting the participant’s health are required. Participants participating in studies using only approved medications (that are not specifically excluded) or devices may qualify for this study.10. Use of personal real-time or intermittent scanned (Flash) CGM, or use of a glucose biosensor, 6months prior to screening. Note: Previous wear of a professional CGM will not be exclusionary. 11. End stage renal disease currently managed by dialysis or anticipating initiating dialysis during the next 6 months, OR eGFR <15. Note: Baseline blinded CGM data collection can be initiated prior to the lab result being available but lab result must be available prior to initiation to verify eligibility.

Cohort 1 Only 12. Thyroid stimulating hormone (TSH) outside the local laboratory’s reference range (above or below). Note: Baseline blinded CGM data collection can be initiated prior to the lab result being available but lab result must be available to verify eligibility before baseline visit. 13. Known severe allergy to medical grade adhesives or a serious skin condition that precludes use of the CGM. 14. Current or planned use of hydroxyurea.


Below are the locations for where you can take part in the trial. Please note that not all sites may be open.

  • Northenden Group Practice
    489 Palatine Road
    Manchester
    M22 4DH
  • Hockley Farm Medical Practice
    39 Hockley Farm Rd
    Leicester
    LE3 1HN
  • Manchester Integrative Medical Practice
    20 Monton Street
    Manchester
    M14 4GP
  • Preston Hill Surgery
    121 Preston Hill
    Harrow
    HA3 9SN
  • Ashton Medical Group LTD
    Chapel Street Ashton-under-Lyne
    Lancashire
    OL6 6EW
  • Shipley Medical Practice
    Alexandra Road, Shipley, West Yorkshire
    Shipley
    BD18 3EG

There may be no direct benefit to participants. However, taking part may help improve understanding of how CGM systems work in everyday primary care settings and contribute to better diabetes care in the future. Participation is voluntary, and individuals may withdraw from the study at any time without it affecting their medical care.
The risks of participation are low. The CGM system is already approved for use in the UK. Possible side effects include mild discomfort, redness, swelling, irritation, itching, bleeding, or infection where the sensor is worn. Blood tests may cause mild discomfort or bruising. There is a small risk to confidentiality, but all personal data will be protected in line with UK data protection laws.

Mr Trivart Shetty
trivart.shetty@dexcom.com


Dr Samuel Seidu
sis11@leicester.ac.uk



The study is sponsored by Dexcom (United States) and funded by Dexcom.





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Read full details for Trial ID: ISRCTN12336055
Last updated 05 May 2026

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