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Clinical Trial NCT04411277 for Continuous Glucose Monitoring is completed. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here. | ||
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Time in Range (TIR) and Time Below Range (TBR) in Insulin-Treated Elderly Patients With Type 2 Diabetes 71 Senior-Focused Observational
Clinical Trial NCT04411277 was an observational study for Continuous Glucose Monitoring that is now completed. The study started on 5 August 2020, with plans to enroll 71 participants. Led by Cline Research Center, the expected completion date was 30 April 2022. The latest data from ClinicalTrials.gov was last updated on 15 June 2022.
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 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 70-18...
Show MoreDetailed 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 identified by medical records at the Hospital da Cruz Vermelha Brasileira-Filial do Paraná and they will be invited to participate in the study by telephone and forwarded to the research center Cline Research Center wher...Show More
Official Title
Time in Range (TIR) and Time Below Range (TBR) in Insulin-Treated Elderly Patients With Type 2 Diabetes
Conditions
Continuous Glucose MonitoringOther Study IDs
- ADC-OUS-IIS-19-47
NCT ID Number
Start Date (Actual)
2020-08-05
Last Update Posted
2022-06-15
Completion Date (Estimated)
2022-04-30
Enrollment (Estimated)
71
Study Type
Observational
Status
Completed
Keywords
Type 2 Diabetes
Elderly
Continuous Glucose Monitoring
Elderly
Continuous Glucose Monitoring
Arms / Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
T2DM Elderly on Insulin CGM 70 patients with type 2 diabetes \> 65 years of age taking insulin as treatment. The sample size was calculated to estimate the minimal number of patients necessary to describe the mean TIR (minutes/day). | Application of the FreeStyle Libre Flash Glucose CGM. Assessment of glycemic control and hypoglycemia, adherence to therapy and CGM use. InBody 270 multifrequency bioimpedance analysis of body composition to calculate appendicular skeletal muscle. |
Primary Outcome Measures
Secondary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
Primary outcome is time in range (TIR) | TIR between 70-180 mg/dL in insulin treated in patients older than 65 years. | 04-07-2021 |
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
-Frequency of hypoglycemia (<70mg/dL, <54mg/dL) to measure Time Bellow Range | * percentage of patients with greater than 5%-time below glucose target (\<70 mg/dL);
* diurnal and nocturnal hypoglycemia; | 04-07-2021 |
-Time in hyperglycemia > 180, 250 mg/dL to measure Time Above Range | * percentage of patients with greater than 5%-time glucose above 250mg/dL
* percentage of patients with greater than 25%-time glucose above 180mg/dL | 04-07-2021 |
-Adherence to CGM use and sensor utilization for diabetes care management using CGM | -assessing the percentage of captured sensor data | 04-07-2021 |
- Rate of emergency room visits and hospitalization | -changing insulin type and dose to prevent hospitalization | 04-07-2021 |
-Glucose Variability | * glycemic variability standard deviation and MAGE(mean amplitude of glycemic excursions)
* glucose variability will be calculated as % coefficient of variation %CV= (standard deviation (SD)/mean glucose x 100%) | 04-07-2021 |
Eligibility Criteria
Eligible Ages
Older Adult
Minimum Age
65 Years
Eligible Sexes
All
- 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
- 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
Cline Research CenterAbbott Diabetes Care188 active studies to exploreStudy Responsible Party
Silmara Leite, Principal Investigator, Director, Cline Research Center
No contact data.
1 Study Locations in 1 Countries
Paraná
Cline Research Center, Curitiba, Paraná, 80030480, Brazil