Real World Evaluation of Advisor Pro in Clinical Practice | NCT04904718

Studies
Real World Evaluation of Advisor Pro in Clinical Practice

NCT04904718

Sponsor

Yale University

Status

Withdrawn

Last Update Posted

Jan 5, 2022Actual

Enrollment

0Actual

Phase

Not Applicable

Conditions

Type1diabetes

Interventions

DreaMed Advisor Pro

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2021

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Decided not to proceed with enrollment - study never started

Expanded Access Info

Start Date

Dec 2021Estimated

Primary Completion Date

Dec 2021Estimated

Completion Date

Dec 2021Estimated

First Submitted Date

May 19, 2021

First Submission Date that Met QC Criteria

May 21, 2021

First Posted Date

May 27, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 14, 2021

Last Update Posted Date

Jan 5, 2022Actual

Name	Class
DreaMed	INDUSTRY

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Label	Type	Description	Intervention Names
DreaMed Advisor Pro tool used for insulin optimization	Experimental		Device: DreaMed Advisor Pro

Name	Type	Description	Arm Group Labels	Other Names
DreaMed Advisor Pro	Device	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

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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
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
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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

6 Years

Maximum Age

30 Years

Standard Ages

ChildAdult

Study Population

Not provided

Sampling Method

Not provided