Diabetes MellitusANSHINNCT04585139
Assessing Non-adjunctive CGM Safety at Home and in New Markets
A study testing Phase 1- Introduction to Dexcom G6 CGM in people with Diabetes Mellitus, run by DexCom, Inc. at 1 site in United States.
Trial summary
The purpose of the study is to examine whether non-adjunctive (without having to double check using another method) use of Continuous Glucose Monitoring improves A1c in adults or children with diabetes managed by intensive insulin therapy. Read more about this study
- Who is it for?
- Ages 2 years and olderHealthy volunteers can take part
- Conditions the study is for
- Diabetes Mellitus
- What is being tested?
- Phase 1- Introduction to Dexcom G6 CGM
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 85 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Oct 2020to 7 Feb 2022
- 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 2 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Age 2 years or older
- A diagnosis of T1D or T2D made at least 6 months prior to enrollment. At least 20 adult participants will have T1D; and 10 will have T2D; 10 participants will be over age 65 years.
- Using IIT (either an insulin pump or MDI)
- HbA1c value ≥ 7.5% (≥ 58 mmol/mol) measured by local lab within prior 30-days before enrollment or by point of care at time of screening.
- eGFR ≥ 30 within the last 90-days prior to enrollment (adult participants only)
- Currently performing 2 or more SMBG fingersticks a day by historical average and willing to continue this during the blinded CGM wear.
Who cannot join
- Use of real-time or intermittently scanned CGM in the 6 months prior to enrollment.
- BMI > 45.
- Anticipated changes to insulin delivery method or insulin formulation(s).
- Insulin formulation changes within class will be permitted if required per formulary change and represent equivalent therapy (eg: insulin lispro change to insulin aspart).
- Pregnancy (as demonstrated by a positive test at study entry) at time of screening or are planning to become pregnant during the study.
- Applicable only to women of reproductive potential.
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- Planned or currently using weight reduction medications, programs or surgery. Defined as 1) using weight loss medications and losing weight (e.g. chronic use of weight loss medications with stable weight is not exclusionary) or planning on using weight loss prescription medication during the study; 2) currently using or planning on initiating a modified fasting program (e.g. protein-sparing diet plans) during the study; or 3) bariatric surgical procedure within the past year or plans for undergoing bariatric surgery during the study.
- Concomitant disease or condition that may compromise patient safety including, but not limited to; severe mental illness, a diagnosed or suspected eating disorder or any uncontrolled long-term medical/psychiatric condition that would interfere with study- related tasks or visits, including ongoing treatment for a significant malignancy. These assessments/conditions are made at investigator's discretion.
- Known (or suspected) significant allergy to medical-grade adhesives.
- Any condition, per investigator assessment, that could impact the stability of the HbA1c measurement, for example,
- Acute or chronic blood loss or bleeding disorder,
- Red blood cell transfusion or erythropoietin, administration in the 3 months prior to enrollment,
- Or red blood cell transfusion or erythropoietin administration anticipated during the course of the study.
- Anticipated acute use of oral or injectable glucocorticoids that could affect glycemic control and impact HbA1c, for example,
- Frequent steroid bursts used for inflammatory arthritis or inflammatory bowel disease,
- Or recurrent lumbar epidural steroid injections,
- Current treatment with hydroxyurea
- Participation in another pharmaceutical or device trial at the time of enrollment or during the study.
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of the study is to examine whether non-adjunctive (without having to double check using another method) use of Continuous Glucose Monitoring improves A1c in adults or children with diabetes managed by intensive insulin therapy.
- Conditions
- Diabetes Mellitus
- Being tested
- Phase 1- Introduction to Dexcom G6 CGM
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Phase 1- Introduction to Dexcom G6 CGMDevice
Examine whether non-adjunctive use of CGM improves glycemic control in adults with diabetes managed by intensive insulin therapy
| Study group | Role | What they receive |
|---|---|---|
| Phase 1 -- Introduction to Dexcom G6 CGM | Other | A 2 week run-in wear period of blinded CGM followed by 12 weeks of wear of a Commercially available CGM Receives: Device: Phase 1- Introduction to Dexcom G6 CGM |
| Phase 2 -- Comparison of an Updated G6 Transmitter to Commercial Dexcom G6 CGM | Active comparator | 1 group will wear a Commercially available CGM for 12 weeks while the 2 group will wear an Updated CGM for 12 weeks. Receives: Device: Phase 1- Introduction to Dexcom G6 CGM |
What is being measured
The primary outcome is the main question the study is designed to answer.
HbA1c
Phase 1 change in HbA1c for the adult cohort only.
Measured: 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2020
- Study start6 Oct 2020
- Primary completion7 Feb 2022
- Study completion7 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes MellitusStudies 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- The study consists of two phases. Phase I is a single-arm, prospective, multicenter, interventional design. Phase II is a randomized controlled arm study during which participants will be randomized 1:1 to Commercial CGM or Updated CGM
- Masking
- None (open label)
- Enrolment
- 85 participants (actual)
Sponsor and investigators
- Lead sponsor
- DexCom, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Jaeb Center for Health Research
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04585139
- Sponsor's protocol ID
- PTL-903833
- Acronym
- ANSHIN
- Status last verified
- Jul 2022
- First submitted
- 5 Oct 2020
- Last updated
- 1 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- 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 1 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing Non-adjunctive CGM Safety at Home and in New Markets
- ClinicalTrials.gov ID
- NCT04585139
- Acronym / sponsor ID
- ANSHIN / PTL-903833
- Conditions
- Diabetes Mellitus
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 85 participants (actual)
- Lead sponsor
- DexCom, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Jaeb Center for Health Research
- Study start
- 6 Oct 2020 (actual)
- Primary completion
- 7 Feb 2022 (actual)
- Study completion
- 7 Feb 2022 (actual)
- First posted
- 14 Oct 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.
The purpose of the study is to examine whether non-adjunctive (without having to double check using another method) use of Continuous Glucose Monitoring improves A1c in adults or children with diabetes managed by intensive insulin therapy.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The study consists of two phases. Phase I is a single-arm, prospective, multicenter, interventional design. Phase II is a randomized controlled arm study during which participants will be randomized 1:1 to Commercial CGM or Updated CGM
| Arm | Type | Receives |
|---|---|---|
| Phase 1 -- Introduction to Dexcom G6 CGM | Other | Device: Phase 1- Introduction to Dexcom G6 CGMA 2 week run-in wear period of blinded CGM followed by 12 weeks of wear of a Commercially available CGM |
| Phase 2 -- Comparison of an Updated G6 Transmitter to Commercial Dexcom G6 CGM | Active comparator | Device: Phase 1- Introduction to Dexcom G6 CGM1 group will wear a Commercially available CGM for 12 weeks while the 2 group will wear an Updated CGM for 12 weeks. |
Who may qualify
- Ages
- 2 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- Age 2 years or older
- A diagnosis of T1D or T2D made at least 6 months prior to enrollment. At least 20 adult participants will have T1D; and 10 will have T2D; 10 participants will be over age 65 years.
- Using IIT (either an insulin pump or MDI)
- HbA1c value ≥ 7.5% (≥ 58 mmol/mol) measured by local lab within prior 30-days before enrollment or by point of care at time of screening.
- eGFR ≥ 30 within the last 90-days prior to enrollment (adult participants only)
Key exclusion criteria (18 listed)
- Use of real-time or intermittently scanned CGM in the 6 months prior to enrollment.
- BMI > 45.
- Anticipated changes to insulin delivery method or insulin formulation(s).
- Insulin formulation changes within class will be permitted if required per formulary change and represent equivalent therapy (eg: insulin lispro change to insulin aspart).
- Pregnancy (as demonstrated by a positive test at study entry) at time of screening or are planning to become pregnant during the study.
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 |
|---|---|---|
| Phase 1- Introduction to Dexcom G6 CGMExamine whether non-adjunctive use of CGM improves glycemic control in adults with diabetes managed by intensive insulin therapy | Device | Phase 1 -- Introduction to Dexcom G6 CGM, Phase 2 -- Comparison of an Updated G6 Transmitter to Commercial Dexcom G6 CGM |
Primary outcome
HbA1c
Time frame: 16 weeks
Phase 1 change in HbA1c for the adult cohort only.
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 1 Aug 2022.
- 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.
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 Phase 1- Introduction to Dexcom G6 CGM in people with Diabetes Mellitus, run by DexCom, 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 6 inclusion and 18 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 1 Aug 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?
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?
HbA1c (time frame: 16 weeks). 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 1 Aug 2022.