Evaluation of Flash Continuous Glucose Monitoring to Reduce Hyperglycemia in People With T2 Diabetes
Status unconfirmed · Not applicable
Conditions studied: Diabetes Mellitus, Type 2
In brief
A multi-center, randomized, prospective, non-significant risk study to compare the impact of the FreeStyle Libre Flash Glucose Monitoring System with and without a food logging smartphone application on reducing time above 180 mg/dL in subjects with type 2 diabetes who are not adequately controlled on their existing oral anti-diabetes medication regimen.
Key facts
- Study ID
- NCT04843527
- Run by
- Abbott Diabetes Care
- People needed
- 350
- Starts
- 2021-04-02
- Expected to finish
- 2025-06-01
- Last updated by the study team
- 2025-01-30
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Subject must be at least 18 years of age.
- Subject has been diagnosed with type 2 diabetes.
- HbA1c greater than or equal to 7.5% and less than or equal to 12%
- Subject is on at least 1 diabetes medication in the classes of metformin, SGLT-2 inhibitors, GLP-1 agonists and DPP-4 inhibitors.
- Subject owns a compatible smartphone
- Subject agrees to a 3-month period of no diabetes medication changes.
- Subject is willing to make diet and lifestyle changes in response to education and glucose data
You may not qualify if…
- Subject is currently on insulin therapy or sulfonylurea-based medications.
- Subject has known allergy to medical grade adhesive or isopropyl alcohol used to disinfect skin.
- Subject is known to be pregnant at the time of study enrollment (applicable to female subjects only).
- Subject has extensive skin changes/diseases at the proposed application sites that could interfere with device placement or the accuracy of interstitial glucose measurements.
Where it is running
- Boston Medical Center — Boston, Massachusetts, United States
- Henry Ford Health System — Detroit, Michigan, United States
- HealthPartners Institute dba International Diabetes Center — Minneapolis, Minnesota, United States
- UMPC — Pittsburgh, Pennsylvania, United States
Full record on ClinicalTrials.gov
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