Continuous Glucose Monitoring as Adjunct to Lifestyle Modification in Prediabetes (FlashLMP)

This is an interventional prevention trial for PreDiabetes Read More

Inclusion Criteria:

1. Impaired glucose tolerance as defined by will be defined as per the American Diabetes Association criteria based on 75g oral glucose tolerance test (OGTT) 2-hour glucose of between 7.8 and less than 11 mmol/L
2. Male or female age ≥ 18 years old and ≤ 65 years old.
3. BMI 18 to 40kg/m2
4. Willingness, ability and commitment to comply with LMP
5. Able to use a CGM as judged by investigator
6. In the opinion of the investigator, absence of any physical limitations, addictive diseases, or underlying medical conditions (including mental health) that may preclude the patient from being a suitable study candidate.
7. Written informed consent to participate in the study provided by the patient.

Exclusion Criteria:

1. Currently pregnant, lactating, as demonstrated by a positive pregnancy test at screening or planning pregnancy
2. Known diabetes
3. Current or previous use of glucose-lowering or weight loss drugs
4. Concurrent participation in other weight loss or lifestyle intervention programmes
5. Any active acute or chronic disease or condition that, in the opinion of the investigator, might interfere with the performance of this study.
6. Any active acute or chronic infectious disease that, in the opinion of the investigator, would pose an excessive risk to study staff.
7. Current use or recent exposure to any medication that in the opinion of the investigator could have an influence on the patient's ability to participate in this study or on the performance of the test device.
8. Extensive skin changes/diseases that preclude wearing the FGM on normal skin at the proposed application sites (e.g., extensive psoriasis, recent burns or severe sunburn, extensive eczema, extensive scarring, extensive tattoos, dermatitis herpetiformis).
9. Known uncontrolled thyrotoxicosis
10. Current use of steroids
11. Have a known allergy to medical-grade adhesives
12. Known current or recent alcohol or drug abuse
13. Currently participating in another investigational study protocol where the testing or results may interfere with study compliance, diagnostic results, or data collection.
14. An identified protected vulnerable patient (including but not limited to those in detention, or a prisoner).