Status:
COMPLETED
Time in Range (TIR) and Time Below Range (TBR) in Insulin-Treated Elderly Patients With Type 2 Diabetes
Lead Sponsor:
Cline Research Center
Collaborating Sponsors:
Abbott Diabetes Care
Conditions:
Continuous Glucose Monitoring
Eligibility:
All Genders
65+ years
Brief Summary
Prospective observational cohort study. Elderly patients \>65 years with type 2 diabetes mellitus (T2DM) on insulin therapy and HbA1c between 7% and 9%, with or without oral agents, will be identified...
Detailed Description
Prospective observational cohort study. Patients over 65 years of age, with TDM2 using insulin with or without the use of associated oral antidiabetic agents and with HbA1c between 7% and 9%, will be ...
Eligibility Criteria
Inclusion
- Age \> 65 years
- Known history of type 2 Diabetes Mellitus
- BMI between 18.5 and 35kg/m2
- HbA1c between 7% and 9.0%
- Insulin with or without oral agent treatment for diabetes mellitus
Exclusion
- Patients using GLP1 (Glucagon-like peptide-1) agonists
- Patients with eGFR\<30 (epidermal growth factor receptor) using (calculated CKD EPI)
- Anemia (Hb\<11 grams)
- Chronic liver chronic disease (ALT\>3xULN)
- Use of glucocorticoids within 3 months preceding the investigation
- Neoplasia treatment
- Inability by the patient or caretaker to commit to protocol instructions and visit schedule.
- Type 1 diabetes
Key Trial Info
Start Date :
August 5 2020
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
April 30 2022
Estimated Enrollment :
71 Patients enrolled
Trial Details
Trial ID
NCT04411277
Start Date
August 5 2020
End Date
April 30 2022
Last Update
June 15 2022
Active Locations (1)
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1
Cline Research Center
Curitiba, Paraná, Brazil, 80030480