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

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ClinicalTrials.gov Identifier: NCT04411277
Recruitment Status : Not yet recruiting
First Posted : June 2, 2020
Last Update Posted : July 23, 2020
Sponsor:
Collaborator:
Abbott Diabetes Care
Information provided by (Responsible Party):
Silmara Leite, Cline Research Center

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.


Condition or disease Intervention/treatment
Continuous Glucose Monitoring Device: Application of the FreeStyle Libre Flash Glucose CGM. Diagnostic Test: InBody 270 multifrequency bioimpedance

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.

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Study Type : Observational
Estimated Enrollment : 70 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Time in Range (TIR) and Time Below Range (TBR) in Insulin-Treated Elderly Patients With Type 2 Diabetes
Estimated Study Start Date : August 5, 2020
Estimated Primary Completion Date : February 16, 2021
Estimated Study Completion Date : April 7, 2021

Resource links provided by the National Library of Medicine


Group/Cohort 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).
Device: Application of the FreeStyle Libre Flash Glucose CGM.
Assessment of glycemic control and hypoglycemia, adherence to therapy and CGM use.

Diagnostic Test: InBody 270 multifrequency bioimpedance
analysis of body composition to calculate appendicular skeletal muscle.




Primary Outcome Measures :
  1. Primary outcome is time in range (TIR) [ Time Frame: 04-07-2021 ]
    TIR between 70-180 mg/dL in insulin treated in patients older than 65 years.


Secondary Outcome Measures :
  1. -Frequency of hypoglycemia (<70mg/dL, <54mg/dL) to measure Time Bellow Range [ Time Frame: 04-07-2021 ]
    • percentage of patients with greater than 5%-time below glucose target (<70 mg/dL);
    • diurnal and nocturnal hypoglycemia;

  2. -Time in hyperglycemia > 180, 250 mg/dL to measure Time Above Range [ Time Frame: 04-07-2021 ]
    • percentage of patients with greater than 5%-time glucose above 250mg/dL
    • percentage of patients with greater than 25%-time glucose above 180mg/dL

  3. -Adherence to CGM use and sensor utilization for diabetes care management using CGM [ Time Frame: 04-07-2021 ]
    -assessing the percentage of captured sensor data

  4. - Rate of emergency room visits and hospitalization [ Time Frame: 04-07-2021 ]
    -changing insulin type and dose to prevent hospitalization

  5. -Glucose Variability [ Time Frame: 04-07-2021 ]
    • 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%)



Information from the National Library of Medicine

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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04411277


Contacts
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Contact: Silmara Leite, MD, PhD +55 41 999634932 oliveiraleite.sil@gmail.com
Contact: Gabriela Soares, Trainee +55 41 3015 7978 gsoares@clinemedica.com.br

Sponsors and Collaborators
Cline Research Center
Abbott Diabetes Care
Investigators
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Principal Investigator: Silmara Leite, MD, PhD Cline Research Center
Additional Information:
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Responsible Party: Silmara Leite, Director, Cline Research Center
ClinicalTrials.gov Identifier: NCT04411277    
Other Study ID Numbers: ADC-OUS-IIS-19-47
First Posted: June 2, 2020    Key Record Dates
Last Update Posted: July 23, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Silmara Leite, Cline Research Center:
Type 2 Diabetes
Elderly
Continuous Glucose Monitoring
Additional relevant MeSH terms:
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Diabetes Mellitus, Type 2
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases