NCT06471699Not yet recruiting
The Effect of Continuous Glucose Monitoring in Individuals With Newly Diagnosed Type 2 Diabetes
A Randomized Trial of the Effect of Continuous Glucose Monitoring (CGM) in Individuals With Newly Diagnosed Type 2 Diabetes
Source: ClinicalTrials.gov · Last updated 24 Jun 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
The aim of the current study is to evaluate effectiveness, sustainability and satisfaction of CGM in adult persons with newly diagnosed type 2 diabetes. The study is a randomized clinical trial randomizing patients to CGM or SMBG over 26 weeks with a follow-up period up to 70 weeks. An extension period will exist between 26 and 70 weeks. Between 26-52 weeks both groups will use only capillary testing for glucose monitoring and during 53-70 weeks the group initially randomized to capillary testing will use CGM. During the extension period similar variables will be evaluated as during the main phase of the trial including HbA1c, CGM-metrics, glucose-lowering medications, physical activity, treatment satisfaction and well-being.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 250 (estimated)
- First submitted
- 11 Jun 2024
- Start date
- 1 Nov 2024
- Primary completion date
- 31 Dec 2027
- Lead sponsor
- Vastra Gotaland Region
- Diseases
- Type 2 diabetes
- NCT number
- NCT06471699
What you commit to
- Study type: Interventional
- Planned participants: 250
- From 1 Nov 2024 to the primary completion date, 31 Dec 2027
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Type 1 diabetes
- Severe cognitive dysfunction or other disease, which is judged by the physician to be not suitable for inclusion.
- History of allergic reaction to chlorhexidine or alcohol anti-septic solution.
Lab values
- Abnormal skin at the anticipated glucose sensor attachment sites (excessive hair, burn, inflammation, infection, rash, and/or tattoo).
Other
- Pregnancy or planned pregnancy for the study duration
- Judged to be in need of insulin
- Participation in another study.
- Other investigator-determined criteria unsuitable for patient participation.
Who the study is looking for
- Type 2 diabetes
- Adults 18 years or older
- Written Informed Consent
- HbA1c greater than or equal to 58 mmol/mol (7.5% DCCT standard) and less than 100 mmol/mol
- Type 2 diabetes diagnosis \<4 weeks
- Body mass index \> 25 kg/m2
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.