Type2 DiabetesCGM_IRB2NCT03252964
Continuous Glucose Monitors to Regulate Glucose Levels in Type 2 Diabetics
A study testing Continuous Glucose Monitor (CGM), Activity Tracker and Coaching in people with Type2 Diabetes, run by Savvysherpa, Inc. at 1 site in United States.
Trial summary
This study allows Type 2 diabetics to receive feedback from a continuous glucose monitor (CGM) as part of an educational program designed to help them better manage their glucose levels. Subjects will also wear an activity tracker to monitor their activity and observe its effect on their glucose levels. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Type2 Diabetes
- What is being tested?
- Continuous Glucose Monitor (CGM), Activity Tracker and Coaching
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Jul 2017to 25 Feb 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Be diagnosed with type 2 diabetes
- Currently take a DPP4 inhibitor, SGLT2 inhibitor, GLP-1 agonist, and/or basal insulin
- Be able to read and understand English
- Have access to a telephone
- Have a Medicare health plan
Who cannot join
- Pregnant
- Blind
- Deaf
- Currently receiving chemotherapy or radiation therapy to treat cancer
- Addicted to any drugs (including alcohol, painkillers, hallucinogens, or others)
- Critically ill
Show all 21Show fewer
- Diagnosed with or experiencing:
- Kidney disease stages 4 and 5
- End stage renal disease
- Severe liver disease
- Dementia
- Schizophrenia
- Bipolar disorder
- Autism
- An intellectual or learning disability
- Arrhythmias other than atrial fibrillation
- Congestive heart failure
- Has had a:
- Myocardial infarction within the last 6 months
- Stroke within the last 6 months
- Stroke that resulted in significant disability (e.g., unable to write clearly or walk)
Trial locations and contacts
1 site in 1 country.
United States1 site
Rogelio Machuca, MD Family Medicine, PLLC
Las Vegas, Nevada, 89104
About this study
Official title: Empowering Medicare Patients to Self-Manage Their Type 2 Diabetes Using Continuous Glucose Monitoring (CGM) - Investigational Device Pilot
This study allows Type 2 diabetics to receive feedback from a continuous glucose monitor (CGM) as part of an educational program designed to help them better manage their glucose levels. Subjects will also wear an activity tracker to monitor their activity and observe its effect on their glucose levels. The educational program will involve calls from coaches to check subjects' progress and answer questions.
- Conditions
- Type2 Diabetes
- Being tested
- Continuous Glucose Monitor (CGM), Activity Tracker, Coaching
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Continuous Glucose Monitor (CGM)Device
Also called Dexcom Investigational Use Only (IUO) Device
Subjects will use a CGM to develop an understanding of how their behaviors influence their glucose levels.
Activity TrackerDevice
Also called Fitbit Charge 2
Subjects will use the activity tracker, in combination with a continuous glucose monitor (CGM), to develop an understanding of how their activity levels affect their glucose levels.
CoachingBehavioural
Coaches will help subjects understand the readings from the CGMs and how they are affected by diet choices, use of diabetes medications, etc. Coaches and subjects will have weekly conversations about CGM data and behaviors that affect CGM readings. Coaching will occur via telephone, text messaging, and automated text messaging.
| Study group | Role | What they receive |
|---|---|---|
| Diabetes Management Educational Program | Experimental | Subjects receive a CGM and activity tracker as part of a educational program to help manage their glucose levels. Receives: Device: Continuous Glucose Monitor (CGM); Device: Activity Tracker; Behavioral: Coaching |
What is being measured
The primary outcome is the main question the study is designed to answer.
Program Enrollment Rate (%)
(Number of patients who signed a consent form)/(Number of patients invited to enroll)
Measured: up to three months
Program Completion Rate (%)
(Number of patients who complete 49 days of CGM use) / (Number of patients who signed the consent form)
Measured: up to six months
Secondary outcomes (9)
Change in A1c Measurement (%)
(Final A1c measure)-(Initial A1c measure)
Measured: Day 0 and Day 180
Weekly Average of Estimated Glucose Values (EGV) (Average)
(Sum of EGV for one week)/(Total number of EGV)
Measured: up to six months
Change in Medication Dosage (mg/Day; U/Day)
(dosage of Rx on Day 180)-(dosage of Rx on Day 0)
Measured: up to six months
Average Age of Participants Who Start Trial (Yrs)
(Sum of ages of all enrollees)/(Total number of enrollees)
Measured: up to three months
Average Age of Participants Who Complete Trial (Yrs)
(Sum of age of patients who complete)/(Total number who complete)
Measured: up to six months
Race of Participants Who Start the Trial (n)
Sum of American Indian or Alaska Native, Sum of Asian, Sum of Black or African American, Sum of Native Hawaiian or Other Pacific Islander, Sum of White
Measured: up to three months
Ethnicity of Participants Who Start the Trial (n)
Sum of Hispanic or Latino and Sum of Not Hispanic or Latino
Measured: up to three months
Texting With Coaches (Daily Average of Text Messages)
(Sum of all text messages)/(Total number of days)
Measured: up to six months
Coaching Participation Rate
(Sum of weekly coaching calls completed)/(Total number of weeks)
Measured: up to six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2017
- Study start28 Jul 2017
- Primary completion23 May 2018
- Study completion25 Feb 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 Type2 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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Savvysherpa, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03252964
- Sponsor's protocol ID
- Pro00021722
- Acronym
- CGM_IRB2
- Status last verified
- May 2019
- First submitted
- 9 Aug 2017
- Last updated
- 24 May 2019
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Empowering Medicare Patients to Self-Manage Their Type 2 Diabetes Using Continuous Glucose Monitoring (CGM) - Investigational Device Pilot
- ClinicalTrials.gov ID
- NCT03252964
- Acronym / sponsor ID
- CGM_IRB2 / Pro00021722
- Conditions
- Type2 Diabetes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Savvysherpa, Inc.Industry (pharma, biotech, devices)
- Study start
- 28 Jul 2017 (actual)
- Primary completion
- 23 May 2018 (actual)
- Study completion
- 25 Feb 2019 (actual)
- First posted
- 17 Aug 2017 (actual)
- Results
- Posted 1 May 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study allows Type 2 diabetics to receive feedback from a continuous glucose monitor (CGM) as part of an educational program designed to help them better manage their glucose levels. Subjects will also wear an activity tracker to monitor their activity and observe its effect on their glucose levels. The educational program will involve calls from coaches to check subjects' progress and answer questions.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Diabetes Management Educational Program | Experimental | Device: Continuous Glucose Monitor (CGM), Device: Activity Tracker, Behavioral: CoachingSubjects receive a CGM and activity tracker as part of a educational program to help manage their glucose levels. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (5 listed)
- Be diagnosed with type 2 diabetes
- Currently take a DPP4 inhibitor, SGLT2 inhibitor, GLP-1 agonist, and/or basal insulin
- Be able to read and understand English
- Have access to a telephone
- Have a Medicare health plan
Key exclusion criteria (21 listed)
- Pregnant
- Blind
- Deaf
- Currently receiving chemotherapy or radiation therapy to treat cancer
- Addicted to any drugs (including alcohol, painkillers, hallucinogens, or others)
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 Monitor (CGM)Also: Dexcom Investigational Use Only (IUO) DeviceSubjects will use a CGM to develop an understanding of how their behaviors influence their glucose levels. | Device | Diabetes Management Educational Program |
| Activity TrackerAlso: Fitbit Charge 2Subjects will use the activity tracker, in combination with a continuous glucose monitor (CGM), to develop an understanding of how their activity levels affect their glucose levels. | Device | Diabetes Management Educational Program |
| CoachingCoaches will help subjects understand the readings from the CGMs and how they are affected by diet choices, use of diabetes medications, etc. Coaches and subjects will have weekly conversations about CGM data and behaviors that affect CGM readings. Coaching will occur via telephone, text messaging, and automated text messaging. | Behavioural | Diabetes Management Educational Program |
Primary outcome
Program Enrollment Rate (%)
Time frame: up to three months
(Number of patients who signed a consent form)/(Number of patients invited to enroll)
Program Completion Rate (%)
Time frame: up to six months
(Number of patients who complete 49 days of CGM use) / (Number of patients who signed the consent form)
9 secondary outcomes
Change in A1c Measurement (%)
Time frame: Day 0 and Day 180
Weekly Average of Estimated Glucose Values (EGV) (Average)
Time frame: up to six months
Change in Medication Dosage (mg/Day; U/Day)
Time frame: up to six months
Average Age of Participants Who Start Trial (Yrs)
Time frame: up to three months
Average Age of Participants Who Complete Trial (Yrs)
Time frame: up to six months
Race of Participants Who Start the Trial (n)
Time frame: up to three months
Ethnicity of Participants Who Start the Trial (n)
Time frame: up to three months
Texting With Coaches (Daily Average of Text Messages)
Time frame: up to six months
Coaching Participation Rate
Time frame: up to six months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 May 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 (CGM), Activity Tracker and Coaching in people with Type2 Diabetes, run by Savvysherpa, Inc. 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 5 inclusion and 21 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 24 May 2019. 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 1 May 2019). 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?
Program Enrollment Rate (%) (time frame: up to three months). The study lists 2 primary outcomes in all. 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 24 May 2019.