Real World Evaluation of Advisor Pro in Clinical Practice

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 Overview

• Status: Withdrawn
• Conditions: Type1diabetes
• Intervention / Treatment: Device: DreaMed Advisor Pro

• Study Type: Interventional
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 years to 30 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: DreaMed Advisor Pro tool used for insulin optimization	Device: DreaMed Advisor Pro; 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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Yale University
• Collaborators: DreaMed
• Investigators: Principal Investigator: Jennifer Sherr, MD, PhD, Yale University

Study record dates

Study Major Dates

• Study Start (Anticipated): December 1, 2021
• Primary Completion (Anticipated): December 1, 2021
• Study Completion (Anticipated): December 1, 2021

Study Registration Dates

• First Submitted: May 19, 2021
• First Submitted That Met QC Criteria: May 21, 2021
• First Posted (Actual): May 27, 2021

Study Record Updates

• Last Update Posted (Actual): January 5, 2022
• Last Update Submitted That Met QC Criteria: December 14, 2021
• Last Verified: December 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Immune System Diseases; Autoimmune Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 1
• Other Study ID Numbers: 2000029019

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No