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Real World Evaluation of Advisor Pro in Clinical Practice

Primary Purpose

Type1diabetes

Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
DreaMed Advisor Pro
Sponsored by
Yale University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Type1diabetes

Eligibility Criteria

6 Years - 30 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    DreaMed Advisor Pro tool used for insulin optimization

    Arm Description

    Outcomes

    Primary Outcome Measures

    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

    Secondary Outcome Measures

    Full Information

    First Posted
    May 19, 2021
    Last Updated
    December 14, 2021
    Sponsor
    Yale University
    Collaborators
    DreaMed
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04904718
    Brief Title
    Real World Evaluation of Advisor Pro in Clinical Practice
    Official Title
    Real World Evaluation of Advisor Pro in Clinical Practice
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2021
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    Decided not to proceed with enrollment - study never started
    Study Start Date
    December 2021 (Anticipated)
    Primary Completion Date
    December 2021 (Anticipated)
    Study Completion Date
    December 2021 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Yale University
    Collaborators
    DreaMed

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Type1diabetes

    7. Study Design

    Primary Purpose
    Health Services Research
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    DreaMed Advisor Pro tool used for insulin optimization
    Arm Type
    Experimental
    Intervention Type
    Device
    Intervention Name(s)
    DreaMed Advisor Pro
    Intervention Description
    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
    Primary Outcome Measure Information:
    Title
    Change in glucose control with the use of DreaMed
    Description
    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
    Time Frame
    6 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    6 Years
    Maximum Age & Unit of Time
    30 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Jennifer Sherr, MD, PhD
    Organizational Affiliation
    Yale University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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    Real World Evaluation of Advisor Pro in Clinical Practice

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