Evaluation of the Dreamed Advisor Pro for Automated Insulin Pump Setting Adjustments in Children and Adolescents With Type 1 Diabetes- The Advice4U Pro Study
Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Rabin Medical Center
With
DreaMed
The Leona M. and Harry B. Helmsley Charitable Trust
Age
10–21
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Subject with Type 1 diabetes (\>1yr since diagnosis)
Age ≥ 10 years up to 21 years
HbA1c at inclusion ≥ 7.0% and ≤ 10%
Insulin infusion pump therapy: "OmniPod®" Insulin pump (insulet Corp., Bedford, "MA", USA) or any Medtronic pump that is comparable with Glooko app for at least 4 months
BMI Standard Deviation Score (SDS) - below the 97th percentile for age
Patients willing to follow study instructions (at least 2 capillary blood glucose readings/day, use the bolus-calculator feature of the pump)
Patient/ parents are required to have minimum computer skills and understanding of navigating the internet
Patients willing to use dexcom sensor for the study duration
Patients/ parents will have to have a smart phone (Apple, Android, Windows)
You may not be if
An episode of diabetic ketoacidosis within the month prior to study entry
Concomitant diseases/ treatment that influence metabolic control
Any significant diseases /conditions including psychiatric disorders and substance abuse that in the opinion of the investigator is likely to affect the subject's ability to complete the study or compromise patient's safety,
Participation in any other interventional study
Known or suspected allergy to trial products such as adhesives, tapes, needles. An allergy to contrast medium, use of other active medical devices (such as pacemaker, ICD) and planned imaging examinations (such as MRI).
Female subject who is pregnant or lactating planning to become pregnant within the planned study duration -Severe hypoglycemia six month prior to enrollment as defined by the American Diabetes Association (ADA) and Endocrine Society as follows: "Severe hypoglycemia is an event requiring assistance of another person to actively administer carbohydrates, glucagon, or take other corrective actions". -
Current use of the following medications: medications that are used to lower blood glucose such as Pramlintide, Metformin and GLP-1 analogs. Beta blockers, glucocorticoids and other medications, which in the judgment of the investigator would be a contraindication to participation in the study (Anticoagulant therapy e.g. Plavix, LMW heparin, Coumadin, Immunosuppressant therapy)
Relevant severe organ disorders (diabetic nephropathy, diabetic retinopathy, diabetic foot syndrome) or any secondary disease or complication of diabetes mellitus
* Subject has unstable or rapidly progressive renal disease or is receiving dialysis
* Subject has active proliferating retinopathy
* Active gastroparesis
Patient suffers from an eating disorder
Clareo Health | Evaluation of the Dreamed Advisor Pro for Automated Insulin Pump Setting Adjustments in Children and Adolescents With Type 1 Diabetes- The Advice4U Pro Study
