Evaluation of the Dreamed Advisor Pro for Automated Insulin Pump Setting Adjustments in Children and Adolescents With Type 1 Diabetes- The Advice4U Pro Study
NCT ID: NCT03003806
Last Updated: 2019-12-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
122 participants
INTERVENTIONAL
2017-10-02
2019-11-10
Brief Summary
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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.
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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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
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
Control group-medical guided recommendations
Insulin pump settings (i.e, basal plan, correction factor, carbohydrate ratio and insulin activity time) will be adjusted by the medical team
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
Interventions
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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
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
Eligibility Criteria
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Inclusion Criteria
* 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)
Exclusion Criteria
* 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
10 Years
21 Years
ALL
No
Sponsors
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DreaMed
INDUSTRY
The Leona M. and Harry B. Helmsley Charitable Trust
OTHER
Rabin Medical Center
OTHER
Responsible Party
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Locations
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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
Countries
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References
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Nimri R, Battelino T, Laffel LM, Slover RH, Schatz D, Weinzimer SA, Dovc K, Danne T, Phillip M; NextDREAM Consortium. Insulin dose optimization using an automated artificial intelligence-based decision support system in youths with type 1 diabetes. Nat Med. 2020 Sep;26(9):1380-1384. doi: 10.1038/s41591-020-1045-7. Epub 2020 Sep 9.
Other Identifiers
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RMC072016ctil
Identifier Type: -
Identifier Source: org_study_id