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

NCT03003806 | Completed DMC

• 1 other identifier: RMC072016ctil
• Study Type: interventional
• Target: 122
• Locations: 4 countries
• Sites: 7

Brief 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. 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. 2.Practical recommendations, alert messages based on aforementioned data
3. 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.

Conditions

Type1 Diabetes Mellitus

Keywords

Insulin pump treatment; Type 1 diabetes; Pump setting advisor

Outcome Measures

Primary Outcomes (2)

• Percentage of glucose readings within range of 70-180 mg/dl (3.9 to 10 mmol/l).

  Final visit (week 31)

• Percentage of glucose readings below 54 mg/dl (3.3 mmol/l)

  Final visit (week 31)

Secondary Outcomes (16)

• HbA1c

  Final visit (week 31)

• Percentage of glucose readings below 70 mg/dl (3.9 mmol/L)

  Final visit (week 31)

• Percentage of readings below 50 mg/dl (2.8 mmol/L)

  Final visit (week 31)

• Percentage of readings above 180 mg/dl (10.0 mmol/L)

  Final visit (week 31)

• Percentage of readings above 240 mg/dl (13.3 mmol/L)

  Final visit (week 31)

Study Arms (2)

DreaMed Advisor Pro

EXPERIMENTAL

Insulin pump settings (i.e, basal plan, correction factor, carbohydrate ratio and insulin activity time) will be adjusted using the DreaMed Advisor Pro

Device: DreaMed Advisor Pro

Control group-medical guided recommendations

ACTIVE COMPARATOR

Insulin pump settings (i.e, basal plan, correction factor, carbohydrate ratio and insulin activity time) will be adjusted by the medical team

Other: Medical guided recommendation

Interventions

DreaMed Advisor Pro DEVICE

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

Medical guided recommendation OTHER

Insulin pump settings (i.e, basal plan, correction factor, carbohydrate ratio and insulin activity time) will be adjusted by the medical team

Control group-medical guided recommendations

Eligibility Criteria

• Age: 10 Years - 21 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Subject with Type 1 diabetes (\>1yr since diagnosis)
• Age ≥ 10 years up to 21 years
• 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 qualify 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

Sponsors & Collaborators

• Rabin Medical Center: lead
• DreaMed: collaborator
• The Leona M. and Harry B. Helmsley Charitable Trust: collaborator

Study Sites (7)

Barbara Davis Center for Childhood Diabetes

Aurora, Colorado, 80045-6511, United States

Location

Yale University School of Medicine

New Haven, Connecticut, 06520-8064, United States

Location

University of Florida College of Medicine

Gainesville, Florida, 32610, United States

Location

Joslin Diabetes Center, One Joslin Place

Boston, Massachusetts, 02215, United States

Location

Diabetes -Zentrum fuer kinder und jugendliche

Hanover, Germany

Location

Schnider children's medical center

Petah Tikva, 49202, Israel

Location

University Children's Hospital

Ljubljana, Slovenia

Location

Related Publications (1)

• 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.

  PMID: 32908282 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 22, 2016
• First Posted: December 28, 2016
• Study Start: October 2, 2017
• Primary Completion: November 10, 2019
• Study Completion: November 10, 2019
• Last Updated: December 27, 2019

Record last verified: 2019-06

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1); DE (1); SL (1); US (4)