Type1diabetesNCT04904718
Real World Evaluation of Advisor Pro in Clinical Practice
A study testing DreaMed Advisor Pro in people with Type1diabetes, run by Yale University.
Trial summary
To assess the integration of the DreaMed Advisor Pro tool into a real-world clinical practice using both in person and virtual visits to assess benefits in glycemia, as measured by the glucose management indicator and other glucose metrics. Read more about this study
- Who is it for?
- Ages 6 to 30 years
- Conditions the study is for
- Type1diabetes
- What is being tested?
- DreaMed Advisor Pro
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Dec 2021to Dec 2021
- 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 6 to 30 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Participant with Type 1 diabetes
- Age ≥ 6 years to <30 years
- Using Insulin infusion pump (CSII) therapy including those with low glucose suspend and predictive low glucose suspend features
- Insulin pump must not use automated insulin delivery (closed loop, artificial pancreas)
- Total daily dose of insulin must be greater than 0.5 units/kg/day
- Participants / parents are required to have minimum computer skills and access to a computer in order to upload their personal devices (Pump, BG meter etc) to Tidepool.
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- Participants using Dexcom sensors will allow access to their account for the study duration
- Participants not using CGM must agree to test BG at least 4 times a day at appropriate intervals
- Participants / parents will have to have a smartphone (Apple or Android and Windows)
Who cannot join
- An episode of diabetic ketoacidosis within the month prior to study entry
- Any significant diseases / conditions including psychiatric disorders and substance abuse that in the opinion of the investigator is likely to affect the subject's ability to complete the study or compromise patient's safety,
- Current participation in any other interventional study
- Female subject who is pregnant or lactating or planning to become pregnant within the planned study duration
- Severe hypoglycemia within six months prior to enrollment as defined by the ADA and Endocrine Society
- Current use of the following medications: medications that are used to lower blood glucose such as Pramlintide, Metformin and GLP-1 analogs. Beta blockers, glucocorticoids and other medications, which in the judgment of the investigator would be a contraindication to participation in the study (Anticoagulant therapy e.g. Plavix, LMW heparin, Coumadin, Immunosuppressant therapy)
- Participants suffers from an eating disorder
About this study
To assess the integration of the DreaMed Advisor Pro tool into a real-world clinical practice using both in person and virtual visits to assess benefits in glycemia, as measured by the glucose management indicator and other glucose metrics.
To determine acceptability of the DreaMed Advisor Pro tool both from a person with diabetes as well as a health care provider perspective.
To quantify the potential reimbursement potential that could be generated with use of the DreaMed Advisor Pro.
- Conditions
- Type1diabetes
- Being tested
- DreaMed Advisor Pro
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DreaMed Advisor ProDevice
Advisor Pro software is a proprietary algorithm, designed to provide a comprehensive analysis of individual diabetes data consisting of glucose levels, insulin delivery history and meal consumption reported
| Study group | Role | What they receive |
|---|---|---|
| DreaMed Advisor Pro tool used for insulin optimization | Experimental | Not described Receives: Device: DreaMed Advisor Pro |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in glucose control with the use of DreaMed
Glucose mangement indicator (GMI) will be used to determine glucose control. The GMI indicates the average A1C level that would be expected based on mean glucose measured in a large number of individuals with diabetes. Mean glucose ideally is derived from at least 14 days of CGM data
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2021
- Study startDec 2021 (estimated)
- Primary completionDec 2021 (estimated)
- Study completionDec 2021 (estimated)
Why it stopped: Decided not to proceed with enrollment - study never started
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type1diabetesStudies of the same condition, open and under way.
- More trials run by Yale 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
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Collaborators
- DreaMed
- Responsible party
- Sponsor
- Investigators
- Jennifer Sherr, MD, PhD, Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04904718
- Sponsor's protocol ID
- 2000029019
- Status last verified
- Dec 2021
- First submitted
- 19 May 2021
- Last updated
- 5 Jan 2022
- Results posted
- No
- Data monitoring committee
- 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 5 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Real World Evaluation of Advisor Pro in Clinical Practice
- ClinicalTrials.gov ID
- NCT04904718
- Acronym / sponsor ID
- 2000029019
- Conditions
- Type1diabetes
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Decided not to proceed with enrollment - study never started
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Collaborators
- DreaMed
- Study start
- Dec 2021 (estimated)
- Primary completion
- Dec 2021 (estimated)
- Study completion
- Dec 2021 (estimated)
- First posted
- 27 May 2021 (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.
To assess the integration of the DreaMed Advisor Pro tool into a real-world clinical practice using both in person and virtual visits to assess benefits in glycemia, as measured by the glucose management indicator and other glucose metrics.
To determine acceptability of the DreaMed Advisor Pro tool both from a person with diabetes as well as a health care provider perspective.
To quantify the potential reimbursement potential that could be generated with use of the DreaMed Advisor Pro.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| DreaMed Advisor Pro tool used for insulin optimization | Experimental | Device: DreaMed Advisor Pro |
Who may qualify
- Ages
- 6 to 30 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (9 listed)
- Participant with Type 1 diabetes
- Age ≥ 6 years to <30 years
- Using Insulin infusion pump (CSII) therapy including those with low glucose suspend and predictive low glucose suspend features
- Participants / parents are required to have minimum computer skills and access to a computer in order to upload their personal devices (Pump, BG meter etc) to Tidepool.
- Participants using Dexcom sensors will allow access to their account for the study duration
Key exclusion criteria (7 listed)
- An episode of diabetic ketoacidosis within the month prior to study entry
- Any significant diseases / conditions including psychiatric disorders and substance abuse that in the opinion of the investigator is likely to affect the subject's ability to complete the study or compromise patient's safety,
- Current participation in any other interventional study
- Female subject who is pregnant or lactating or planning to become pregnant within the planned study duration
- Severe hypoglycemia within six months prior to enrollment as defined by the ADA and Endocrine Society
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 |
|---|---|---|
| DreaMed Advisor ProAdvisor Pro software is a proprietary algorithm, designed to provide a comprehensive analysis of individual diabetes data consisting of glucose levels, insulin delivery history and meal consumption reported | Device | DreaMed Advisor Pro tool used for insulin optimization |
Primary outcome
Change in glucose control with the use of DreaMed
Time frame: 6 months
Glucose mangement indicator (GMI) will be used to determine glucose control. The GMI indicates the average A1C level that would be expected based on mean glucose measured in a large number of individuals with diabetes. Mean glucose ideally is derived from at least 14 days of CGM data
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 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.
Jennifer Sherr, MD, PhD principal investigator
Yale University
Questions about this trial
What is this clinical trial studying?
A study testing DreaMed Advisor Pro in people with Type1diabetes, run by Yale University.
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: withdrawn, as of the sponsor's last update on 5 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
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 was withdrawn before enrolling participants, so there are no results.
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 glucose control with the use of DreaMed (time frame: 6 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 5 Jan 2022.