Clinical trial NCT04904718: Real World Evaluation of Advisor Pro in Clinical Practice
Official title: Real World Evaluation of Advisor Pro in Clinical Practice
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Type1diabetes
Lead sponsor: Yale University
Sponsor class: OTHER
Collaborators: name: DreaMed
First posted: 2021-05-27
Enrollment: 0
Sex: ALL
Minimum age (years): 6
Maximum age (years): 30
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief 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.

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.


Eligibility criteria: Inclusion Criteria:

1. Participant with Type 1 diabetes
2. Age ≥ 6 years to \<30 years
3. Using Insulin infusion pump (CSII) therapy including those with low glucose suspend and predictive low glucose suspend features

   1. Insulin pump must not use automated insulin delivery (closed loop, artificial pancreas)
   2. Total daily dose of insulin must be greater than 0.5 units/kg/day
4. 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.
5. Participants using Dexcom sensors will allow access to their account for the study duration
6. Participants not using CGM must agree to test BG at least 4 times a day at appropriate intervals
7. Participants / parents will have to have a smartphone (Apple or Android and Windows)

Exclusion Criteria:

1. An episode of diabetic ketoacidosis within the month prior to study entry
2. 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,
3. Current participation in any other interventional study
4. Female subject who is pregnant or lactating or planning to become pregnant within the planned study duration
5. Severe hypoglycemia within six months prior to enrollment as defined by the ADA and Endocrine Society
6. 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)
7. Participants suffers from an eating disorder

Primary outcomes:
measure: Change in glucose control with the use of DreaMed
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Yale University
name: Jennifer Sherr, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: