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Evaluation of Remote Consultation to Patients With Type 1 Diabetes Under Continuous Glucose Sensors and Insulin Pump Therapy Using the DreaMed Advisor Pro. An Open Label, Randomized Non-inferiority Study of Insulin Pump Therapy Adjustments Between DreaMed Advisor Pro and Standard of Care-The Advisor Pro Direct Study
The DreaMed Advisor Pro is a software which automatically analyses treatment information, learns patient's needs and accordingly suggests adjustments in insulin dosing. DreaMed Advisor Pro is a decision- support software intended for assisting healthcare professionals in the management of type 1 diabetes patients who use insulin pumps as their insulin delivery therapy and monitor their blood glucose levels using CGM (Continuous Glucose Monitoring) or CGM and self-management blood glucose meter. The main objective of the proposed study is to test the safety, reliability, and efficacy of the DreaMed Advisor Pro algorithm when the recommendation is sent directly to the patient without a physician review. Participants will be randomized in a 1:1 ratio to either the intervention group (DreaMed Advisor Pro) or control group (standard of care). Participants will download the CGM and pump data at no less frequent than every 4 weeks for both groups during the 3 months period of the study. Each time new data is received, the following actions will be performed: In the intervention group, a new algorithm recommendation for pump settings will be issued. The recommendation will be approved by a technical, non-physician to assure that glucose data are not fall within predefined safety criteria which require a physician approval before the recommendation will be sent to the patient, otherwise, recommendation will be sent directly to the patient. In the control group, if no safety criteria is met, it is the responsibility of the patient to contact his/her physician to advise on change of treatment. In case a safety issue has occurred, the physician will contact the patient and change the pump settings. Prior to initiating the interventional phase of the study, we will evaluate the experience of patients in self adjustments of insulin dosing in regular care management and to evaluate their acceptance for using an automated dosing recommendations software. The evaluation will be done by asking patients/caregivers to fill 15 questions survey. 100 patients are anticipated to participate in this phase of the study.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
Schnider Children's medical center
Petah Tikva, Israel
Start Date
December 1, 2020
Primary Completion Date
December 1, 2023
Completion Date
December 1, 2023
Last Updated
November 19, 2025
100
ACTUAL participants
DreaMed Advisor Pro
DEVICE
Medical guided recommendation
OTHER
Lead Sponsor
Rabin Medical Center
Collaborators
NCT07051005
NCT06390371
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT03228732