NCT03003806

Evaluation of the Dreamed Advisor Pro for Automated Insulin Pump Setting Adjustments in Children and Adolescents With Type 1 Diabetes- The Advice4U Pro Study

Evaluation of the Dreamed Advisor Pro for Automated Insulin Pump Setting Adjustments in Children and Adolescents With Type 1 Diabetes- Open Label, Parallel , Randomized, Controlled Multicenter Study-The Advice4U Pro Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 122 (actual)
• Sponsor: Rabin Medical Center · Academic / Other
• Sex: All
• Age: 10 Years – 21 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Type1 Diabetes Mellitus

Interventions

Type	Name	Description
DEVICE	DreaMed Advisor Pro	Insulin pump settings (i.e, basal plan, correction factor, carbohydrate ratio and insulin activity time) will be adjusted using the DreaMed Advisor Pro
OTHER	Medical guided recommendation	Insulin pump settings (i.e, basal plan, correction factor, carbohydrate ratio and insulin activity time) will be adjusted by the medical team

Timeline

• Start date: 2017-10-02
• Primary completion: 2019-11-10
• Completion: 2019-11-10
• First posted: 2016-12-28
• Last updated: 2019-12-27

Locations

7 sites across 4 countries: United States, Germany, Israel, Slovenia