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

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 where the study procedures will be carried out. Patients from the private clinic of neurology and endocrinology Cline will also be invited by telephone. In this way the sample of patients will include patients from the public and private health system.

On the first visit to the research centers, after signing the informed consent form (ICF), patients will be evaluated for the presence of other comorbidities associated with diabetes such as the presence of cardiovascular disease, hypertension and dyslipidemia.

The screening for the presence of sarcopenia will be performed with the application of the SARC-F questionnaire; measuring muscle strength with grip strength; the functional test of getting up from the chair without supporting the arms and walking for 3 meters, turning 180º and returning to sit. The time in which the elderly person performs this task is timed and the time up to 20 seconds is considered normal.

Patients will undergo a complete physical examination and body composition analysis using the InBody 270 multifrequency bioimpedance to calculate the appendicular skeletal musculature.

After the first evaluation at the research centers, patients will be referred to partner laboratories that use the same methodologies for measuring HbA1c, blood count, urea, creatinine, glutamic oxalacetic transaminase (TGO) and glutamic-pyruvic transaminase (TGP), which will be performed only at the initial visit.

During the second visit to the research center, the FreeStyle Libre Flash interstitial glucose sensor will be inserted for the first time in the posterior and upper arm and the patient will be instructed to read the glucose at least 10 times a day, being sure to check glucose for a period longer than 8 hours. The patient should be instructed to return to the research center every 2 weeks to change the sensor until completing the 6-week period.

The patient's travel to the research center will be reimbursed by the study team. The study will be carried out at the Hospital da Cruz Vermelha Brasileira-Filial do Paraná, located in Curitiba in partnership with the independent research center Cline Research Center (CRC). Eligible patients will be randomly selected from clinical outpatients at participating institutions, concomitantly.

Inclusion criteria

• 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 criteria

• 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