Status:
COMPLETED
isCGM With Education and Feedback for Non-Insulin Dependent Type 2 Diabetes
Lead Sponsor:
University of Alberta
Collaborating Sponsors:
Epidemiology Coordinating and Research Centre, Canada
Conditions:
Diabetes Mellitus, Type 2
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Glycemic control is an important for adults with diabetes. Self-monitoring of glucose can help adults with type 2 diabetes (T2DM) meet their glucose targets. Continuous glucose monitoring (CGM), an al...
Detailed Description
Objective: To evaluate the effectiveness of intermittently scanned continuous glucose monitoring (isCGM) with education and feedback on glycemic control at 12 weeks, in adults with type 2 diabetes and...
Eligibility Criteria
Inclusion
- Age \>= 18 years with type 2 diabetes.
- HbA1c \> 7.0% within the last 6 months.
- Non-insulin therapy.
- Able to attend two in-person study visits.
- English-speaking.
- Community-dwelling
- In possession of a cell phone capable of accessing the internet and receiving FreeStyle Libre 2 sensor readings
- Has a primary care provider who has been in contact with the patient for diabetes in the last 12 months.
Exclusion
- Type 1 diabetes or diabetes clearly identified as having monogenetic etiology (e.g.: MODY).
- Steroid-induced diabetes if steroid use is on-going or most recently taken within the last 3 months.
- Pregnancy; plans to become pregnant within 6 months; breast-feeding.
- Any use of insulin in the previous year.
- Current or previous use of isCGM or rtCGM within the last 6 months.
- Cognitive dysfunction (SPMSQ score \>= 5).
- Symptoms of acute metabolic decompensation (extreme thirst, high urinary output, and weight loss, accompanied by acute fatigue or dyspnea).
- Any terminal condition that would limit life expectancy to \< 1 year.
- Inability to use isCGM (e.g.: afraid of the device).
- Inability to be reached by telephone.
- Concurrent participation in a different diabetes-related trial.
- Has not already received two doses of a Health Canada-approved vaccine against SARS-CoV-2.
Key Trial Info
Start Date :
October 5 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 12 2024
Estimated Enrollment :
105 Patients enrolled
Trial Details
Trial ID
NCT05319496
Start Date
October 5 2022
End Date
March 12 2024
Last Update
February 6 2025
Active Locations (1)
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1
University of Alberta Hospital / Kaye Edmonton Clinic
Edmonton, Alberta, Canada, T6G 1Z1