Diabetes MellitusNCT03477838
Pharmacist-driven CGM Use in the Uninsured Population
A study testing FreeStyle LibrePro CGM in people with Diabetes Mellitus, run by Virginia Commonwealth University at 1 site in United States.
Trial summary
This is a pilot study. The purpose is to (1) provide access to continuous glucose monitoring (CGM) to patients (purchased through a grant) and (2) systematically record and analyze the results of the glucose monitoring by the clinical pharmacists at the clinic. Read more about this study
- Who is it for?
- Ages 18 to 89 years
- Conditions the study is for
- Diabetes Mellitus
- What is being tested?
- FreeStyle LibrePro CGM
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Apr 2018to 19 Dec 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 to 89 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- adult 18 years of age or older
- diagnosis of Type 1 or Type 2 diabetes
- A1c greater than 8%
- prescribed basal insulin plus either prandial insulin or a glucagon-like peptide-1 (GLP-1) receptor agonist
Who cannot join
- pregnant or breast-feeding
- on dialysis
- not appropriate for CGM use based on clinical judgment by the investigators
- patients with limited English proficiency
Trial locations and contacts
1 site in 1 country.
United States1 site
Virginia Commonwealth University
Richmond, Virginia, 23298
About this study
Official title: A Pharmacist-driven Continuous Glucose Monitoring Program for Advanced Diabetes Management in an Uninsured Population
This is a pilot study. The purpose is to (1) provide access to continuous glucose monitoring (CGM) to patients (purchased through a grant) and (2) systematically record and analyze the results of the glucose monitoring by the clinical pharmacists at the clinic.
- Conditions
- Diabetes Mellitus
- Being tested
- FreeStyle LibrePro CGM
- Keywords
- continuous glucose monitoring
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FreeStyle LibrePro CGMDevice
a professional CGM device will be worn by the participant for up to 14 days
| Study group | Role | What they receive |
|---|---|---|
| CGM Intervention arm | Experimental | Patients eligible for care at the free clinic with diabetes and A1c greater than 8% on insulin therapy will be identified for CGM use. Receives: Device: FreeStyle LibrePro CGM |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in A1c
Change in A1c will be used to assess glycemic control
Measured: Baseline to week 12
Secondary outcomes (2)
Medication Changes
Data will be collected on what medication changes are made (changes in types of medications and doses)
Measured: Baseline to week 12
Glycemic Variability
Data collected by the CGM, such as time-in-therapeutic range, will be evaluated to assess glycemic variability during the 14 day period of wearing the CGM
Measured: Baseline to week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2018
- Study start26 Apr 2018
- Primary completion19 Dec 2019
- Study completion19 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by Virginia Commonwealth UniversityThe sponsor's other registered studies.
- 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
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Virginia Commonwealth University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Evan Sisson, PharmD, Principal investigator, Virginia Commonwealth University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03477838
- Sponsor's protocol ID
- HM20012049
- Status last verified
- Jan 2021
- First submitted
- 19 Mar 2018
- Last updated
- 5 Feb 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pharmacist-driven Continuous Glucose Monitoring Program for Advanced Diabetes Management in an Uninsured Population
- ClinicalTrials.gov ID
- NCT03477838
- Acronym / sponsor ID
- HM20012049
- Conditions
- Diabetes Mellitus
- Keywords
- continuous glucose monitoring
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Virginia Commonwealth UniversityUniversity, hospital or other
- Study start
- 26 Apr 2018 (actual)
- Primary completion
- 19 Dec 2019 (actual)
- Study completion
- 19 Dec 2019 (actual)
- First posted
- 26 Mar 2018 (actual)
- Results
- Posted 5 Feb 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a pilot study. The purpose is to (1) provide access to continuous glucose monitoring (CGM) to patients (purchased through a grant) and (2) systematically record and analyze the results of the glucose monitoring by the clinical pharmacists at the clinic.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CGM Intervention arm | Experimental | Device: FreeStyle LibrePro CGMPatients eligible for care at the free clinic with diabetes and A1c greater than 8% on insulin therapy will be identified for CGM use. |
Who may qualify
- Ages
- 18 to 89 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- adult 18 years of age or older
- diagnosis of Type 1 or Type 2 diabetes
- A1c greater than 8%
- prescribed basal insulin plus either prandial insulin or a glucagon-like peptide-1 (GLP-1) receptor agonist
Key exclusion criteria (4 listed)
- pregnant or breast-feeding
- on dialysis
- not appropriate for CGM use based on clinical judgment by the investigators
- patients with limited English proficiency
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 |
|---|---|---|
| FreeStyle LibrePro CGMa professional CGM device will be worn by the participant for up to 14 days | Device | CGM Intervention arm |
Primary outcome
Change in A1c
Time frame: Baseline to week 12
Change in A1c will be used to assess glycemic control
2 secondary outcomes
Medication Changes
Time frame: Baseline to week 12
Glycemic Variability
Time frame: Baseline to week 12
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
Evan Sisson, PharmD principal investigator
Virginia Commonwealth University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing FreeStyle LibrePro CGM in people with Diabetes Mellitus, run by Virginia Commonwealth University 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 4 inclusion and 4 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 5 Feb 2021. 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?
Yes. Results are posted in the registry (first posted 5 Feb 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 A1c (time frame: Baseline to week 12). 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 5 Feb 2021.