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

NCT04411277 | Completed

• 1 other identifier: ADC-OUS-IIS-19-47
• Study Type: observational
• Target: 71
• Locations: 1 country
• Sites: 1

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 70-180 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

Keywords

Type 2 Diabetes; Elderly; Continuous Glucose Monitoring

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (5)

• -Frequency of hypoglycemia (<70mg/dL, <54mg/dL) to measure Time Bellow Range

  04-07-2021

• -Time in hyperglycemia > 180, 250 mg/dL to measure Time Above Range

  04-07-2021

• -Adherence to CGM use and sensor utilization for diabetes care management using CGM

  04-07-2021

• - Rate of emergency room visits and hospitalization

  04-07-2021

• -Glucose Variability

  04-07-2021

Study Arms (1)

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).

Device: Application of the FreeStyle Libre Flash Glucose CGM.; Diagnostic Test: InBody 270 multifrequency bioimpedance

Interventions

Application of the FreeStyle Libre Flash Glucose CGM. DEVICE

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

T2DM Elderly on Insulin CGM

InBody 270 multifrequency bioimpedance DIAGNOSTIC_TEST

analysis of body composition to calculate appendicular skeletal muscle.

T2DM Elderly on Insulin CGM

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Elderly patients \>65 years with 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Cline Research Center: lead
• Abbott Diabetes Care: collaborator

Study Sites (1)

Cline Research Center

Curitiba, Paraná, 80030480, Brazil

Location

Related Links

• The physiology of endocrine systems with ageing
• Diabetes in the older patient: heterogeneity requires individualization of therapeutic strategies
• Continuous Glucose Monitoring Versus Usual Care in Patients With Type 2 Diabetes Receiving Multiple Daily Insulin Injections: A Randomized Trial.
• Estimating the mean and variance from the median, range, and the size of a sample.
• A power primer.
• The Relationship of Hemoglobin A1C to Time-in-Range in Patients with Diabetes.

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Silmara Leite, MD, PhD

  Cline Research Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: May 6, 2020
• First Posted: June 2, 2020
• Study Start: August 5, 2020
• Primary Completion: April 30, 2022
• Study Completion: April 30, 2022
• Last Updated: June 15, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)