The DreaMed Advisor Pro is a software which automatically analyses treatment information, learns patient's needs and accordingly suggests adjustments in insulin dosing. The DreaMed 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 and has three main components: 1. A statistical analysis of the insulin pump and sensor data: insulin delivery, bolus-calculator rate of use, sensor glucose variables, hypoglycemic and hyperglycemia patterns. 2. Practical recommendations, alert messages based on aforementioned data 3. 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 main goal of the DreaMed Advisor Pro is to improve diabetes management for subjects with Type 1 Diabetes (T1D) by using an innovative Advisor to determine insulin dosing for pump users. The main objective of the proposed study is to evaluate the safety and efficacy of using the DreaMed Advisor Pro algorithm versus medical guided recommendation to determine insulin dosing for sub-optimal controlled subjects with type 1 diabetes using pump therapy.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
122
Insulin pump settings (i.e, basal plan, correction factor, carbohydrate ratio and insulin activity time) will be adjusted using the DreaMed Advisor Pro
Insulin pump settings (i.e, basal plan, correction factor, carbohydrate ratio and insulin activity time) will be adjusted by the medical team
Barbara Davis Center for Childhood Diabetes
Aurora, Colorado, United States
Yale University School of Medicine
New Haven, Connecticut, United States
University of Florida College of Medicine
Gainesville, Florida, United States
Joslin Diabetes Center, One Joslin Place
Boston, Massachusetts, United States
Diabetes -Zentrum fuer kinder und jugendliche
Hanover, Germany
Schnider children's medical center
Petah Tikva, Israel
University Children's Hospital
Ljubljana, Slovenia
Percentage of glucose readings within range of 70-180 mg/dl (3.9 to 10 mmol/l).
Time frame: Final visit (week 31)
Percentage of glucose readings below 54 mg/dl (3.3 mmol/l)
Time frame: Final visit (week 31)
HbA1c
Time frame: Final visit (week 31)
Percentage of glucose readings below 70 mg/dl (3.9 mmol/L)
Time frame: Final visit (week 31)
Percentage of readings below 50 mg/dl (2.8 mmol/L)
Time frame: Final visit (week 31)
Percentage of readings above 180 mg/dl (10.0 mmol/L)
Time frame: Final visit (week 31)
Percentage of readings above 240 mg/dl (13.3 mmol/L)
Time frame: Final visit (week 31)
Area above the curve of glucose glucose level of 180 mg/dl
Time frame: Final visit (week 31)
Area under the curve of glucose level of 70 mg/dl
Time frame: Final visit (week 31)
Mean sensor blood glucose
Time frame: Final visit (week 31)
Glucose variability measured by Standard Deviation
Time frame: Final visit (week 31)
Number of recommendations for changes in settings per patient
Time frame: Final visit (week 31)
Number of recommendations for changes in settings per iteration
Time frame: Final visit (week 31)
Number of physician override Advisor recommendations
Time frame: Final visit (week 31)
Number of patients overrides of recommendation
Time frame: Final visit (week 31)
Estimated time duration needed for the physician to give its recommendations
Time frame: Final visit (week 31)
Device satisfaction questionaire
Time frame: Final visit (week 31)
Diabetes treatment satisfaction questionnaire
Time frame: Final visit (week 31)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.