The Effect of Continuous Glucose Monitoring in Individuals With Newly Diagnosed Type 2 Diabetes

Launched by VASTRA GOTALAND REGION · Jun 17, 2024

Keywords

ClinConnect Summary

This clinical trial is studying how effective and satisfying continuous glucose monitoring (CGM) is for adults who have recently been diagnosed with type 2 diabetes. The trial will compare CGM with traditional finger-stick blood glucose monitoring over a period of 26 weeks, followed by an additional follow-up period of up to 70 weeks. During the first half, participants will be either using CGM or standard testing methods, and then all participants will switch to using only finger-stick testing for a year before the group that started with finger-sticks will also try CGM. The study will look at important health measures, treatment satisfaction, and overall well-being throughout this time.

To participate in this trial, individuals must be at least 18 years old, have been diagnosed with type 2 diabetes within the last 4 weeks, and have certain blood sugar levels. They should also have a body mass index (BMI) greater than 25, which indicates being overweight. However, people who are pregnant, have type 1 diabetes, or have certain health issues will not be eligible. Participants can expect to learn more about their blood sugar levels and how to manage their diabetes while also helping researchers understand the best ways to use CGM technology.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Type 2 diabetes
• • 2. Adults 18 years or older
• • 3. Written Informed Consent
• • 4. HbA1c greater than or equal to 58 mmol/mol (7.5% DCCT standard) and less than 100 mmol/mol
• • 5. Type 2 diabetes diagnosis \<4 weeks
• • 6. Body mass index \> 25 kg/m2
• Exclusion Criteria:
• • 1. Pregnancy or planned pregnancy for the study duration
• • 2. Type 1 diabetes
• • 3. Judged to be in need of insulin
• • 4. Severe cognitive dysfunction or other disease, which is judged by the physician to be not suitable for inclusion.
• • 5. History of allergic reaction to chlorhexidine or alcohol anti-septic solution.
• • 6. Abnormal skin at the anticipated glucose sensor attachment sites (excessive hair, burn, inflammation, infection, rash, and/or tattoo).
• • 7. Participation in another study.
• • 8. Other investigator-determined criteria unsuitable for patient participation.