Clinical trial NCT04411277: Time in Range (TIR) and Time Below Range (TBR) in Insulin-Treated Elderly Patients With Type 2 Diabetes
Official title: Time in Range (TIR) and Time Below Range (TBR) in Insulin-Treated Elderly Patients With Type 2 Diabetes
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Continuous Glucose Monitoring
Keywords: Type 2 Diabetes
Elderly
Continuous Glucose Monitoring
Lead sponsor: Cline Research Center
Sponsor class: OTHER
Collaborators: name: Abbott Diabetes Care
First posted: 2020-06-02
Enrollment: 71
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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 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.

Eligibility criteria: 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

Primary outcomes:
measure: Primary outcome is time in range (TIR)
timeFrame: 04-07-2021
Secondary outcomes:
measure: -Frequency of hypoglycemia (<70mg/dL, <54mg/dL) to measure Time Bellow Range
timeFrame: 04-07-2021
measure: -Time in hyperglycemia > 180, 250 mg/dL to measure Time Above Range
timeFrame: 04-07-2021
measure: -Adherence to CGM use and sensor utilization for diabetes care management using CGM
timeFrame: 04-07-2021
measure: - Rate of emergency room visits and hospitalization
timeFrame: 04-07-2021
measure: -Glucose Variability
timeFrame: 04-07-2021
Other outcomes:
Locations:
city: Curitiba
country: Brazil
facility: Cline Research Center
state: PR
Study officials:
affiliation: Cline Research Center
name: Silmara Leite, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: