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

Type1 Diabetes Mellitus Clinical Trial

Official title:
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

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03003806
Study type Interventional
Source Rabin Medical Center
Contact
Status Completed
Phase N/A
Start date October 2, 2017
Completion date November 10, 2019
View Details
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