An interventional study of DreaMed Advisor Pro in Type 1 Diabetes, sponsored by Rabin Medical Center. Completed at 1 site in Israel. Open to participants aged 6 Years to 65 Years. Per ClinicalTrials.gov, last updated 2024-03-26.
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 (FDA approved decision support system). The Advisor Pro uses information gathered from glucose monitoring (sensor readings or capillary blood glucose measurements), insulin dosing and meal data during daily routine home care. Following a 5 minute data collection and analysis, the algorithm learns and suggests pump-setting changes for optimization of glucose control. The algorithm is designed as an advisory tool for health care professionals and has three main components: First, data analysis report - a statistical analysis of the insulin pump and sensor data: insulin delivery, bolus-calculator rate of use, sensor glucose variables, hypoglycemic and hyperglycemic patterns. Second, recommendations, alert messages based on aforementioned data for example "pay attention- you skipped boluses", basal/bolus ratio is too high, bolus delivery compliance, glucose target recommendations and more. Third, a recommendation for new insulin pump settings: including basal intervals and rate, different carbohydrate ratio according to time of day, correction factor and insulin sensitivity time. The Advisor Pro can be used to optimize insulin pump setting during clinical visits, in-between visits or as part of virtual (telemedicine) visit. The objective of the proposed study is to evaluate the use of Advisor Pro by Health Care Providers for regular clinical visits and in between visits titration for adjustment of insulin pump settings. The study design is an open label, prospective, observational study that will include up to 100 participants with Type 1 Diabetes using insulin pumps and monitoring glucose levels by continuous glucose monitoring including flash glucose monitoring.
10,925 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.
This study's enrollment of 70 is below the median of 80 across 8,367 interventional studies indexed under Diabetes Mellitus.
Browse Diabetes Mellitus 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, such as:
Using the DreaMed Advisor Pro as an advisory tool for Health Care Professionals during routine clinical use
Device: DreaMed Advisor Pro
Using the DreaMed Advisor Pro as an advisory tool for Health Care Professionals during routine clinical use
HbA1c
Time frame: Through study completion , an average of 1 year
Percentage of glucose readings within target range of 70-180 mg/dl
Time frame: Through study completion, an average of 1 year
Percentage of glucose sensor readings below 54 mg/dl
Time frame: Through study completion, an average of 1 year
Percentage of glucose sensor readings above 250 mg/dl
Time frame: Through study completion, an average of 1 year
Percentage of glucose sensor readings 70-54 mg/dl
Time frame: Through study completion, an average of 1 year
Percentage of glucose sensor readings 180-250 mg/dl
Time frame: Through study completion, an average of 1 year
Mean sensor glucose
Time frame: Through study completion, an average of 1 year
Glucose variability
Time frame: Through study completion, an average of 1 year
Total insulin dose
Time frame: Through study completion, an average of 1 year
Total basal insulin dose
Time frame: Through study completion, an average of 1 year
Total Bolus insulin dose
Time frame: Through study completion, an average of 1 year
Total daily consumed carbohydrates
Time frame: Through study completion, an average of 1 year
Number of recommendations for changes in the treatment plan per patient
Time frame: Through study completion, an average of 1 year
Number of physician overrides of advisor recommendations
Time frame: Through study completion, an average of 1 year
Device satisfaction
Device satisfaction evaluated by Healthcare Professionals Survey containing 50 items, Device satisfaction evaluated by Healthcare Professionals Survey containing 50 items, 28 of them are on 5-point scale ranging from "strongly agree" to "strongly disagree", 10 items are "yes"/ "no" questions and 12 items are opened questions.
Time frame: at the end of the intervention period (1 year)
Frequency of home phone visits
Time frame: Through study completion, an average of 1 year
Time required to review insulin pump and sensor data, make and send recommendations or length of visit
will be measured by timer
Time frame: Through study completion, an average of 1 year
This study is completed, as verified in Mar 2024. You cannot join it, but the record below documents what was studied.
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Rabin Medical Center