Continuous Glucose MonitoringNCT04411277
Time in Range (TIR) and Time Below Range (TBR) in Insulin-Treated Elderly Patients With Type 2 Diabetes
An observational study of Continuous Glucose Monitoring, run by Cline Research Center at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Continuous Glucose Monitoring
- What is being tested?
- Application of the FreeStyle Libre Flash Glucose CGM. and InBody 270 multifrequency bioimpedance
- Type of treatment
- Medical device
- How many people
- 71 participants
- Where
- 1 siteBrazil
- Study dates
- 5 Aug 2020to 30 Apr 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read more
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.
Read the 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.
- Conditions
- Continuous Glucose Monitoring
- Being tested
- Application of the FreeStyle Libre Flash Glucose CGM., InBody 270 multifrequency bioimpedance
- Keywords
- Type 2 Diabetes, Elderly, Continuous Glucose Monitoring
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Application of the FreeStyle Libre Flash Glucose CGM.Device
Assessment of glycemic control and hypoglycemia, adherence to therapy and CGM use.
InBody 270 multifrequency bioimpedanceDiagnostic test
analysis of body composition to calculate appendicular skeletal muscle.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Device: Application of the FreeStyle Libre Flash Glucose CGM.; Diagnostic Test: InBody 270 multifrequency bioimpedance |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary outcome is time in range (TIR)
TIR between 70-180 mg/dL in insulin treated in patients older than 65 years.
Measured: 04-07-2021
Secondary outcomes (5)
-Frequency of hypoglycemia (<70mg/dL, <54mg/dL) to measure Time Bellow Range
- percentage of patients with greater than 5%-time below glucose target (<70 mg/dL);
- diurnal and nocturnal hypoglycemia;
Measured: 04-07-2021
-Time in hyperglycemia > 180, 250 mg/dL to measure Time Above Range
- percentage of patients with greater than 5%-time glucose above 250mg/dL
- percentage of patients with greater than 25%-time glucose above 180mg/dL
Measured: 04-07-2021
-Adherence to CGM use and sensor utilization for diabetes care management using CGM
-assessing the percentage of captured sensor data
Measured: 04-07-2021
- Rate of emergency room visits and hospitalization
-changing insulin type and dose to prevent hospitalization
Measured: 04-07-2021
-Glucose Variability
- 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%)
Measured: 04-07-2021
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2020
- Study start5 Aug 2020
- Primary completion30 Apr 2022
- Study completion30 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Continuous Glucose MonitoringStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 71 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cline Research Center
- Sponsor type
- University, hospital or other
- Collaborators
- Abbott Diabetes Care
- Responsible party
- Principal investigator, Silmara Leite, Cline Research Center
- Investigators
- Silmara Leite, MD, PhD, Principal investigator, Cline Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04411277
- Sponsor's protocol ID
- ADC-OUS-IIS-19-47
- Status last verified
- Jun 2022
- First submitted
- 6 May 2020
- Last updated
- 15 Jun 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Time in Range (TIR) and Time Below Range (TBR) in Insulin-Treated Elderly Patients With Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT04411277
- Acronym / sponsor ID
- ADC-OUS-IIS-19-47
- Conditions
- Continuous Glucose Monitoring
- Keywords
- Type 2 Diabetes, Elderly, Continuous Glucose Monitoring
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 71 participants (actual)
- Lead sponsor
- Cline Research CenterUniversity, hospital or other
- Collaborators
- Abbott Diabetes Care
- Study start
- 5 Aug 2020 (actual)
- Primary completion
- 30 Apr 2022 (actual)
- Study completion
- 30 Apr 2022 (actual)
- First posted
- 2 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| T2DM Elderly on Insulin CGM | – | Device: Application of the FreeStyle Libre Flash Glucose CGM., Diagnostic Test: InBody 270 multifrequency bioimpedance70 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). |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- 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.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Application of the FreeStyle Libre Flash Glucose CGM.Assessment of glycemic control and hypoglycemia, adherence to therapy and CGM use. | Device | T2DM Elderly on Insulin CGM |
| InBody 270 multifrequency bioimpedanceanalysis of body composition to calculate appendicular skeletal muscle. | Diagnostic test | T2DM Elderly on Insulin CGM |
Primary outcome
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.
5 secondary outcomes
-Frequency of hypoglycemia (<70mg/dL, <54mg/dL) to measure Time Bellow Range
Time frame: 04-07-2021
-Time in hyperglycemia > 180, 250 mg/dL to measure Time Above Range
Time frame: 04-07-2021
-Adherence to CGM use and sensor utilization for diabetes care management using CGM
Time frame: 04-07-2021
- Rate of emergency room visits and hospitalization
Time frame: 04-07-2021
-Glucose Variability
Time frame: 04-07-2021
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2022.
- The physiology of endocrine systems with ageingLink provided by the sponsor.
- Diabetes in the older patient: heterogeneity requires individualization of therapeutic strategiesLink provided by the sponsor.
- Continuous Glucose Monitoring Versus Usual Care in Patients With Type 2 Diabetes Receiving Multiple Daily Insulin Injections: A Randomized Trial.Link provided by the sponsor.
- Estimating the mean and variance from the median, range, and the size of a sample.Link provided by the sponsor.
- A power primer.Link provided by the sponsor.
- The Relationship of Hemoglobin A1C to Time-in-Range in Patients with Diabetes.Link provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Silmara Leite, MD, PhD principal investigator
Cline Research Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Continuous Glucose Monitoring, run by Cline Research Center at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary outcome is time in range (TIR) (time frame: 04-07-2021). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jun 2022; AzTrials last refreshed its copy on 1 Nov 2026.