Type 2 DiabetesNCT05200390
Evaluation of a Single Center Expansion of Continuous Glucose Monitor Access in Patients With Type 2 Diabetes
A study testing Continuous glucose monitor in people with Type 2 Diabetes, run by Chieh Chen at 1 site in United States.
Trial summary
The purpose of this pilot study is to hopefully generate interest that will lead to more robust trials evaluating FreeStyle Libre 2 sensors in patients with type 2 diabetes on any diabetes regimen. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- Continuous glucose monitor
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Jan 2022to Feb 2023
- Phase
- Interventional
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of Type 2 Diabetes with
- Hemoglobin A1c above goal 6.5%-8% based on participant specific factors defined in the ADA guidelines (e.g. comorbidities and age) OR
- Identified glycemic excursions, including hypoglycemia based on documented blood glucose readings of < 70 mg/dL via point-of-care glucose testing, lab testing or self-monitoring or reported signs and symptoms of hypoglycemia documented in the medical record
- Referred and actively followed by pharmacy for at least 3 months prior to study enrollment
- Have at least one encounter with pharmacist within the last 3 months
- Have at least one A1c documented while under pharmacist care
Show all 9Show fewer
- On at least one anti-diabetic medication
- Demonstrates willingness (at the discretion of the investigators) to scan the CGM several times a day
- Demonstrates willingness (at the discretion of the investigators) to attend regular office visits or phone calls
Who cannot join
- Currently pregnant or actively trying to conceive
- Receiving dialysis
- Currently followed by the endocrinology clinic for diabetes
- Current or past CGM use in the last 6 months prior to study enrollment
- Participant meets criteria for insurance coverage of CGM
- Known allergy to medical adhesive
- Wearing any implanted medical device
Trial locations and contacts
1 site in 1 country.
United States1 site
Upstate Health Care Center
Syracuse, New York, 13202
About this study
Official title: Closing the Gap in Health Disparities and Improving Health Outcomes: Evaluation of a Single Center Expansion of Continuous Glucose Monitor Access in Patients With Type 2 Diabetes
The purpose of this pilot study is to hopefully generate interest that will lead to more robust trials evaluating FreeStyle Libre 2 sensors in patients with type 2 diabetes on any diabetes regimen. Hopefully the trial will ultimately pave the way to future trials that will prompt clinicians, policymakers, and insurers to re-evaluate the current criteria defining the coverage of continuous glucose monitors (CGM).
The objectives of the study are to 1) Determine if there is difference in diabetes control in adult participants with type 2 diabetes before and after management with FreeStyle Libre 2, 2) Compare participant satisfaction with glucose monitoring and diabetes distress in adult participants with type 2 diabetes before and after management with FreeStyle Libre 2 and 3) Compare the frequency of hypoglycemia in adult participants with type 2 diabetes before and after management with FreeStyle Libre 2.
Read the detailed description
This will be a prospective, single-center, pre-post pilot study where enrolled participants will be given free FreeStyle Libre 2 sensors for 3 months and will be followed by pharmacists in the Upstate Adult Medicine Clinic.
During the first visit, pharmacists will order a baseline hemoglobin A1c, confirm the participant's current medication list, provide CGM education and assess patient's willingness to scan. Participants will also be asked to participate in a voluntary initial satisfaction survey (Glucose Monitoring Satisfaction Survey). Sensors will be placed at the end of the first visit. No medication changes will be made in order to obtain baseline data for each participant. All initial visits will be conducted in-office. Baseline characteristics will be collected at this visit.
The second visit will be scheduled approximately 2 weeks after the initial visit and will also be in-office. Since no medication changes were made during the first visit, the second visit will provide baseline CGM data, which will be reviewed with the participant. All subsequent follow-up visits will be scheduled at 2-week intervals unless an earlier visit is determined to be necessary by the pharmacist. At the discretion of the pharmacists, subsequent follow-up visits can either be a telemedicine encounter or an in-office visit. CGM data and medication changes will be documented at each visit.
The final visit will be scheduled approximately 3 months after sensor placement and will be in-office. Participants will be asked to participate in the post satisfaction survey (Glucose Monitoring Satisfaction Survey). Pharmacists will repeat the hemoglobin A1c, review the final medication list, remove the sensors, and review plan for self-monitoring blood glucose with patient moving forward.
- Conditions
- Type 2 Diabetes
- Being tested
- Continuous glucose monitor
- Keywords
- continuous glucose monitor, FreeStyle Libre 2, health disparity, pharmacists
- 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.
Continuous glucose monitorDevice
FreeStyle Libre 2 system
| Study group | Role | What they receive |
|---|---|---|
| Continuous Glucose Monitor | Experimental | Adult patients with Type 2 Diabetes on any anti-diabetic regimen utilizing continuous glucose monitors for 3 months Receives: Device: Continuous glucose monitor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in percent time in range of 70-180mg/dL (%TIR)
Percentage
Measured: From baseline and at 3 months
Secondary outcomes (43)
Change in Glucose Monitoring Satisfaction Survey (GMSS) scores
Numeric number
Measured: From baseline and at 3 month
Change in %TIR
Percentage
Measured: From baseline and at 1 month
Change in %TIR
Percentage
Measured: From baseline and at 2 months
Change in hemoglobin A1c
Percentage
Measured: From baseline and at 3 months
Change in Percent Time Active
Percentage
Measured: From baseline and at 1 month
Change in Percent Time Active
Percentage
Measured: From baseline and at 2 months
Change in Percent Time Active
Percentage
Measured: From baseline and at 3 months
Change in Percent Time Below Range less than 54mg/dL (%TBR <54mg/dL)
Percentage
Measured: From baseline and at 1 month
Change in %TBR <54mg/dL
Percentage
Measured: From baseline and at 2 months
Change in %TBR <54mg/dL
Percentage
Measured: From baseline and at 3 months
Change in Percent Time Below Range less than 70mg/dL (%TBR <70mg/dL)
Percentage
Measured: From baseline and at 1 month
Change in %TBR <70mg/dL
Percentage
Measured: From baseline and at 2 months
Change in %TBR <70mg/dL
Percentage
Measured: From baseline and at 3 months
Change in Percent Time Above Range more than 180mg/dL (%TAR >180mg/dL)
Percentage
Measured: From baseline and at 1 month
Change in %TAR >180mg/dL
Percentage
Measured: From baseline and at 2 months
Change in %TAR >180mg/dL
Percentage
Measured: From baseline and at 3 months
Change in Percent Time Above Range more than 250mg/dL (%TAR >250mg/dL)
Percentage
Measured: From baseline and at 1 month
Change in %TAR >250mg/dL
Percentage
Measured: From baseline and at 2 months
Change in %TAR >250mg/dL
Percentage
Measured: From baseline and at 3 months
Change in Percent Coefficient of Variation (%CV)
Percentage
Measured: From baseline and at 1 month
Change in %CV
Percentage
Measured: From baseline and at 2 months
Change in %CV
Percentage
Measured: From baseline and at 3 months
Percentage of patients at goal %TIR
Percentage
Measured: 1 month
Percentage of patients at goal %TIR
Percentage
Measured: 2 months
Percentage of patients at goal %TIR
Percentage
Measured: 3 months
Percentage of patients at goal % Time Active
Percentage
Measured: 1 month
Percentage of patients at goal % Time Active
Percentage
Measured: 2 months
Percentage of patients at goal % Time Active
Percentage
Measured: 3 months
Percentage of patients at goal %TBR <54mg/dL
Percentage
Measured: 1 month
Percentage of patients at goal %TBR <54mg/dL
Percentage
Measured: 2 months
Percentage of patients at goal %TBR <54mg/dL
Percentage
Measured: 1, 2, and
Percentage of patients at goal %TBR <70mg/dL
Percentage
Measured: 1 month
Percentage of patients at goal %TBR <70mg/dL
Percentage
Measured: 2 months
Percentage of patients at goal %TBR <70mg/dL
Percentage
Measured: 3 months
Percentage of patients at goal %TAR >180mg/dL
Percentage
Measured: 1 month
Percentage of patients at goal %TAR >180mg/dL
Percentage
Measured: 2 months
Percentage of patients at goal %TAR >180mg/dL
Percentage
Measured: 3 months
Percentage of patients at goal %TAR >250mg/dL
Percentage
Measured: 1 month
Percentage of patients at goal %TAR >250mg/dL
Percentage
Measured: 2 months
Percentage of patients at goal %TAR >250mg/dL
Percentage
Measured: 3 months
Percentage of patients at goal % CV
Percentage
Measured: 1 month
Percentage of patients at goal % CV
Percentage
Measured: 2 months
Percentage of patients at goal % CV
Percentage
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2022
- Study start24 Jan 2022
- Primary completionNov 2022 (estimated)
- Study completionFeb 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 DiabetesStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chieh Chen
- Sponsor type
- University, hospital or other
- Collaborators
- St. John Fisher College
- Responsible party
- Sponsor-investigator, Chieh Chen, State University of New York - Upstate Medical University
- Investigators
- Elizabeth Phillips, PharmD, CACP, Principal investigator, St. John Fisher College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05200390
- Sponsor's protocol ID
- 1788320
- Status last verified
- May 2022
- First submitted
- 6 Jan 2022
- Last updated
- 4 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Closing the Gap in Health Disparities and Improving Health Outcomes: Evaluation of a Single Center Expansion of Continuous Glucose Monitor Access in Patients With Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT05200390
- Acronym / sponsor ID
- 1788320
- Conditions
- Type 2 Diabetes
- Keywords
- continuous glucose monitor, FreeStyle Libre 2, health disparity, pharmacists
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Chieh ChenUniversity, hospital or other
- Collaborators
- St. John Fisher College
- Study start
- 24 Jan 2022 (actual)
- Primary completion
- Nov 2022 (estimated)
- Study completion
- Feb 2023 (estimated)
- First posted
- 20 Jan 2022 (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.
The purpose of this pilot study is to hopefully generate interest that will lead to more robust trials evaluating FreeStyle Libre 2 sensors in patients with type 2 diabetes on any diabetes regimen. Hopefully the trial will ultimately pave the way to future trials that will prompt clinicians, policymakers, and insurers to re-evaluate the current criteria defining the coverage of continuous glucose monitors (CGM).
The objectives of the study are to 1) Determine if there is difference in diabetes control in adult participants with type 2 diabetes before and after management with FreeStyle Libre 2, 2) Compare participant satisfaction with glucose monitoring and diabetes distress in adult participants with type 2 diabetes before and after management with FreeStyle Libre 2 and 3) Compare the frequency of hypoglycemia in adult participants with type 2 diabetes before and after management with FreeStyle Libre 2.
Detailed description
This will be a prospective, single-center, pre-post pilot study where enrolled participants will be given free FreeStyle Libre 2 sensors for 3 months and will be followed by pharmacists in the Upstate Adult Medicine Clinic.
During the first visit, pharmacists will order a baseline hemoglobin A1c, confirm the participant's current medication list, provide CGM education and assess patient's willingness to scan. Participants will also be asked to participate in a voluntary initial satisfaction survey (Glucose Monitoring Satisfaction Survey). Sensors will be placed at the end of the first visit. No medication changes will be made in order to obtain baseline data for each participant. All initial visits will be conducted in-office. Baseline characteristics will be collected at this visit.
The second visit will be scheduled approximately 2 weeks after the initial visit and will also be in-office. Since no medication changes were made during the first visit, the second visit will provide baseline CGM data, which will be reviewed with the participant. All subsequent follow-up visits will be scheduled at 2-week intervals unless an earlier visit is determined to be necessary by the pharmacist. At the discretion of the pharmacists, subsequent follow-up visits can either be a telemedicine encounter or an in-office visit. CGM data and medication changes will be documented at each visit.
The final visit will be scheduled approximately 3 months after sensor placement and will be in-office. Participants will be asked to participate in the post satisfaction survey (Glucose Monitoring Satisfaction Survey). Pharmacists will repeat the hemoglobin A1c, review the final medication list, remove the sensors, and review plan for self-monitoring blood glucose with patient moving forward.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Continuous Glucose Monitor | Experimental | Device: Continuous glucose monitorAdult patients with Type 2 Diabetes on any anti-diabetic regimen utilizing continuous glucose monitors for 3 months |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Diagnosis of Type 2 Diabetes with
- Referred and actively followed by pharmacy for at least 3 months prior to study enrollment
- Have at least one encounter with pharmacist within the last 3 months
- Have at least one A1c documented while under pharmacist care
- On at least one anti-diabetic medication
Key exclusion criteria (7 listed)
- Currently pregnant or actively trying to conceive
- Receiving dialysis
- Currently followed by the endocrinology clinic for diabetes
- Current or past CGM use in the last 6 months prior to study enrollment
- Participant meets criteria for insurance coverage of CGM
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 |
|---|---|---|
| Continuous glucose monitorFreeStyle Libre 2 system | Device | Continuous Glucose Monitor |
Primary outcome
Change in percent time in range of 70-180mg/dL (%TIR)
Time frame: From baseline and at 3 months
Percentage
43 secondary outcomes
Change in Glucose Monitoring Satisfaction Survey (GMSS) scores
Time frame: From baseline and at 3 month
Change in %TIR
Time frame: From baseline and at 1 month
Change in %TIR
Time frame: From baseline and at 2 months
Change in hemoglobin A1c
Time frame: From baseline and at 3 months
Change in Percent Time Active
Time frame: From baseline and at 1 month
Change in Percent Time Active
Time frame: From baseline and at 2 months
Change in Percent Time Active
Time frame: From baseline and at 3 months
Change in Percent Time Below Range less than 54mg/dL (%TBR <54mg/dL)
Time frame: From baseline and at 1 month
Change in %TBR <54mg/dL
Time frame: From baseline and at 2 months
Change in %TBR <54mg/dL
Time frame: From baseline and at 3 months
Change in Percent Time Below Range less than 70mg/dL (%TBR <70mg/dL)
Time frame: From baseline and at 1 month
Change in %TBR <70mg/dL
Time frame: From baseline and at 2 months
Change in %TBR <70mg/dL
Time frame: From baseline and at 3 months
Change in Percent Time Above Range more than 180mg/dL (%TAR >180mg/dL)
Time frame: From baseline and at 1 month
Change in %TAR >180mg/dL
Time frame: From baseline and at 2 months
Change in %TAR >180mg/dL
Time frame: From baseline and at 3 months
Change in Percent Time Above Range more than 250mg/dL (%TAR >250mg/dL)
Time frame: From baseline and at 1 month
Change in %TAR >250mg/dL
Time frame: From baseline and at 2 months
Change in %TAR >250mg/dL
Time frame: From baseline and at 3 months
Change in Percent Coefficient of Variation (%CV)
Time frame: From baseline and at 1 month
Change in %CV
Time frame: From baseline and at 2 months
Change in %CV
Time frame: From baseline and at 3 months
Percentage of patients at goal %TIR
Time frame: 1 month
Percentage of patients at goal %TIR
Time frame: 2 months
Percentage of patients at goal %TIR
Time frame: 3 months
Percentage of patients at goal % Time Active
Time frame: 1 month
Percentage of patients at goal % Time Active
Time frame: 2 months
Percentage of patients at goal % Time Active
Time frame: 3 months
Percentage of patients at goal %TBR <54mg/dL
Time frame: 1 month
Percentage of patients at goal %TBR <54mg/dL
Time frame: 2 months
Percentage of patients at goal %TBR <54mg/dL
Time frame: 1, 2, and
Percentage of patients at goal %TBR <70mg/dL
Time frame: 1 month
Percentage of patients at goal %TBR <70mg/dL
Time frame: 2 months
Percentage of patients at goal %TBR <70mg/dL
Time frame: 3 months
Percentage of patients at goal %TAR >180mg/dL
Time frame: 1 month
Percentage of patients at goal %TAR >180mg/dL
Time frame: 2 months
Percentage of patients at goal %TAR >180mg/dL
Time frame: 3 months
Percentage of patients at goal %TAR >250mg/dL
Time frame: 1 month
Percentage of patients at goal %TAR >250mg/dL
Time frame: 2 months
Percentage of patients at goal %TAR >250mg/dL
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2022.
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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.
Elizabeth Phillips, PharmD, CACP principal investigator
St. John Fisher College
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Continuous glucose monitor in people with Type 2 Diabetes, run by Chieh Chen at 1 site in United States.
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 9 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 4 May 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 United States. 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?
Results are not available in the source record.
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?
Change in percent time in range of 70-180mg/dL (%TIR) (time frame: From baseline and at 3 months). 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 4 May 2022.