NCT03003806: Advice4U

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

Completed NA Last updated 27 December 2019

What this trial tests

NA trial testing DreaMed Advisor Pro in Type1 Diabetes Mellitus in 122 participants. Completed in 10 November 2019.

Timeline

2 October 2017

Primary endpoint
10 November 2019

10 November 2019

Quick facts

Lead sponsor	Rabin Medical Center
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	122
Start date	2 October 2017
Primary completion	10 November 2019
Estimated completion	10 November 2019
Sites	7 locations across Slovenia, Israel, United States, Germany

Drugs / interventions tested

• DreaMed Advisor Pro
• Medical guided recommendation

Conditions studied

• Type1 Diabetes Mellitus — all drugs for Type1 Diabetes Mellitus →

Sponsor

Rabin Medical Center

Who can join

Adults 10 to 21, any sex, with Type1 Diabetes Mellitus. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

1. Insulin dose optimization using an automated artificial intelligence-based decision support system in youths with type 1 diabetes.
   Nimri R, Battelino T, Laffel LM, Slover RH, et al · · 2020 · cited 140× · PMID 32908282 · DOI 10.1038/s41591-020-1045-7
2. Adjustment of Insulin Pump Settings in Type 1 Diabetes Management: Advisor Pro Device Compared to Physicians' Recommendations.
   Nimri R, Oron T, Muller I, Kraljevic I, et al · · 2022 · cited 17× · PMID 33100030 · DOI 10.1177/1932296820965561
3. Mapping the landscape of machine learning in chronic disease management: A comprehensive bibliometric study.
   Shen S, Qi W, Li S, Zeng J, et al · · 2025 · cited 2× · PMID 40727621 · DOI 10.1177/20552076251361614
4. Transparency and Validity of Artificial Intelligence Applications in Pediatric Diabetes: A Systematic Review.
   Hamza Yousif BA, Alsadig Abdalwahab Abdallah AB, Ibrahim Abdelhalim AA, Mohammedosman ME, et al · · 2025 · PMID 40895926 · DOI 10.7759/cureus.89093