Status:
WITHDRAWN
Real World Evaluation of Advisor Pro in Clinical Practice
Lead Sponsor:
Yale University
Collaborating Sponsors:
DreaMed
Conditions:
Type1diabetes
Eligibility:
All Genders
6-30 years
Phase:
NA
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 managem...
Eligibility Criteria
Inclusion
- 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.
- 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)
Exclusion
- 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
Key Trial Info
Start Date :
December 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2021
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04904718
Start Date
December 1 2021
End Date
December 1 2021
Last Update
January 5 2022
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