Real World Evaluation of Advisor Pro in Clinical Practice

NCT ID: NCT04904718

Last Updated: 2022-01-05

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-12-31
• Study Completion Date: 2021-12-31

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.

Conditions

Type1diabetes

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

DreaMed Advisor Pro tool used for insulin optimization

Group Type: EXPERIMENTAL

DreaMed Advisor Pro

Intervention Type: 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

Interventions

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

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 30 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

DreaMed

INDUSTRY

Sponsor Role: collaborator

Yale University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jennifer Sherr, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Yale University

Other Identifiers

2000029019

Identifier Type: -

Identifier Source: org_study_id