An interventional study of DreaMed Advisor Pro and Medical guided recommendation in Type 1 Diabetes Mellitus, sponsored by Rabin Medical Center. Terminated at 1 site in Israel. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-11-19.
Sponsored by Rabin Medical Center · Not applicable, Interventional, and Treatment
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.
3,522 studies on the registry are indexed under Diabetes Mellitus, Type 1; 577 are open to participants now.
This study's enrollment of 100 is above the median of 40 across 2,649 interventional studies indexed under Diabetes Mellitus, Type 1.
Browse Diabetes Mellitus, Type 1 studies →Rabin Medical Center is the lead sponsor of 385 studies on the registry; 30 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Relevant severe organ disorders (diabetic nephropathy, diabetic retinopathy, diabetic foot syndrome) or any secondary disease or complication of diabetes mellitus.
Insulin pump settings (i.e, basal plan, correction factor, carbohydrate ratio and insulin activity time) will be adjusted using the DreaMed Advisor pro.
Device: DreaMed Advisor Pro
Insulin pump settings (i.e, basal plan, correction factor, carbohydrate ration and insulin activity time) will be adjusted by the medical team
Other: Medical guided recommendation
Insulin pump settings (i.e, basal plan, correction factor, carbohydrate ratio and insulin activity time) will be adjusted using the DreaMed Advisor Pro and sent directly to the patient
Insulin pump settings (i.e, basal plan, correction factor, carbohydrate ratio and insulin activity time) will be adjusted by the medical team according to standard of care
Percentage of glucose readings within range of 70-180 mg/dl (3.9 to 10mmol/L)
Time frame: Final visit (week 12)
Percentage of readings below 54 mg/dl (3.3 mmol/l)
Time frame: Final visit (week 12)
HbA1c
Time frame: Final visit (week 12)
Diabetes treatment satisfaction questionnaire
The questionnaire contains 12-14 items (12 for the teens version and 14 for the parents version) the subscale for each items is from 0 to 6, and for most items the the higher the score, the greater the satisfaction with the treatment.Subscales are summed. More specific instruction for analysis are detailed in Diabetologia 52:(suppl 1) S397, Abstruct 1013 and in a document named "Summary of recommended scoring" by Prof. Bradley, University of London
Time frame: Final visit (week 12)
Percentage of glucose readings below 70 mg/dl (3.9 mmol/L)
Time frame: Final visit (week 12)
Percentage of readings below 60 mg/dl (3.35mmol/L)
Time frame: Final visit (week 12)
Percentage of readings above 180 mg/dl (10.0mmol/L)
Time frame: Final visit (week 12)
percentage of readings above 250 mg/dl (13.9 mmol/L)
Time frame: Final visit (week 12)
Area above the curve of glucose level of 180 mg/dl
Time frame: Final visit (week 12)
Area above the curve of glucose level above180 mg/dl
Time frame: Final visit (week 12)
Area under the curve of glucose level of 70 mg/dl
Time frame: Final visit (week 12)
Area under the curve of glucose level below 70 mg/dl
Time frame: Final visit (week 12)
Mean sensor blood glucose
Time frame: Final visit (week 12)
Glucose variability measured by standard deviation
Time frame: Final visit (week 12)
Number of recommendations sent to patient in the last 6 months prior to baseline and during intervention period
Time frame: Final visit (week 12)
Number of recommendations for changes in settings per patient
Time frame: Final visit (week 12)
Number of recommendations for changes in settings per iteration
Time frame: Final visit (week 12)
Number of physician override Advisor recommendation
Time frame: Final visit (week 12)
Plan to share: No
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This study is terminated, as verified in Nov 2025. You cannot join it, but the record below documents what was studied.
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Rabin Medical Center