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Time in Range (TIR) and Time Below Range (TBR) in Insulin-Treated Elderly Patients With Type 2 Diabetes

NCT04411277 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 71

Last updated 2022-06-15

No results posted yet for this study

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 from medical records and invited to participate. Patients will wear a FreeStyle Libre Flash CGM during a 6-week study period.

Using CGM technology, we will assess an efficacy outcome : time in range (TIR) between 70-180 mg/dl and a safety outcome: incidence of hypoglycemia (time below range (TBR) less than 70, 54, and 40 mg/dl in insulin treated older adults with T2DM.

Patients will return to clinic every 2 weeks for new continuous glucose monitoring (CGM) placement, assessment of glycemic control and hypoglycemia, adherence to therapy and CGM use.

CGM data will be downloaded every 2 weeks.

Conditions

  • Continuous Glucose Monitoring

Interventions

DEVICE

Application of the FreeStyle Libre Flash Glucose CGM.

Assessment of glycemic control and hypoglycemia, adherence to therapy and CGM use.

DIAGNOSTIC_TEST

InBody 270 multifrequency bioimpedance

analysis of body composition to calculate appendicular skeletal muscle.

Sponsors & Collaborators

  • Abbott Diabetes Care

    collaborator INDUSTRY

  • Cline Research Center

    lead OTHER

Principal Investigators

  • Silmara Leite, MD, PhD · Cline Research Center

Eligibility

Min Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-08-05
Primary Completion
2022-04-30
Completion
2022-04-30

Countries

  • Brazil

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04411277 on ClinicalTrials.gov