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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

71 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-08-05

Study Completion Date

2022-04-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Time-In-Range Based Risk Stratification of Type 2 Diabetes Microvascular Complications

NCT05787990

Type 2 Diabetes Diabetes Related Complications Diabetes; Retinopathy (Manifestation) +2 more

UNKNOWN

Association Between Time in Range and In-hospital Outcomes in Type 2 Diabetic Patients With Acute Coronary Syndrome

NCT05389254

Type 2 Diabetes Mellitus Acute Coronary Syndrome

UNKNOWN NA

Evaluation of Intra-Abdominal Fat in Patients With Type 2 Diabetes Using a Non-Invasive Method

NCT01283113

Obesity Type 2 Diabetes Metabolic Syndrome

COMPLETED

SMBG Protocols Predicting Glucose Levels in Senior Diabetes Mellitus With CAD

NCT01954771

Diabetes Mellitus, Type 2 Coronary Artery Disease

COMPLETED NA

Atheroma Progression and Vulnerability Under Continuous Glucose Monitoring

NCT04559191

Coronary Atherosclerosis

UNKNOWN PHASE4

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Continuous Glucose Monitoring

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Intervention Type DEVICE

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

InBody 270 multifrequency bioimpedance

Intervention Type DIAGNOSTIC_TEST

analysis of body composition to calculate appendicular skeletal muscle.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Application of the FreeStyle Libre Flash Glucose CGM.

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

Intervention Type DEVICE

InBody 270 multifrequency bioimpedance

analysis of body composition to calculate appendicular skeletal muscle.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No