Real World Evaluation of Advisor Pro in Clinical Practice

Study Overview
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Brief Summary
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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.

Official Title
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Real World Evaluation of Advisor Pro in Clinical Practice

Conditions
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Type1diabetes

Intervention / Treatment
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* Device: DreaMed Advisor Pro


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Criteria: 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

Ages Eligible for Study
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Minimum Age: 6 Years
Maximum Age: 30 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: DreaMed Advisor Pro tool used for insulin optimization<br> | Device: DreaMed Advisor Pro<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 6 months |