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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)

Primary Purpose

Type1 Diabetes Mellitus

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
DreaMed Advisor Pro
Medical guided recommendation
Sponsored by
Rabin Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Type1 Diabetes Mellitus focused on measuring Insulin pump treatment, Type 1 diabetes, Pump setting advisor

Eligibility Criteria

10 Years - 21 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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)

Exclusion Criteria:

  • 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

Sites / Locations

  • Barbara Davis Center for Childhood Diabetes
  • Yale University School of Medicine
  • University of Florida College of Medicine
  • Joslin Diabetes Center, One Joslin Place
  • Diabetes -Zentrum fuer kinder und jugendliche
  • Schnider children's medical center
  • University Children's Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

DreaMed Advisor Pro

Control group-medical guided recommendations

Arm Description

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

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

Outcomes

Primary Outcome Measures

Percentage of glucose readings within range of 70-180 mg/dl (3.9 to 10 mmol/l).
Percentage of glucose readings below 54 mg/dl (3.3 mmol/l)

Secondary Outcome Measures

HbA1c
Percentage of glucose readings below 70 mg/dl (3.9 mmol/L)
Percentage of readings below 50 mg/dl (2.8 mmol/L)
Percentage of readings above 180 mg/dl (10.0 mmol/L)
Percentage of readings above 240 mg/dl (13.3 mmol/L)
Area above the curve of glucose glucose level of 180 mg/dl
Area under the curve of glucose level of 70 mg/dl
Mean sensor blood glucose
Glucose variability measured by Standard Deviation
Number of recommendations for changes in settings per patient
Number of recommendations for changes in settings per iteration
Number of physician override Advisor recommendations
Number of patients overrides of recommendation
Estimated time duration needed for the physician to give its recommendations
Device satisfaction questionaire
Diabetes treatment satisfaction questionnaire

Full Information

First Posted
December 22, 2016
Last Updated
December 26, 2019
Sponsor
Rabin Medical Center
Collaborators
DreaMed, The Leona M. and Harry B. Helmsley Charitable Trust
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1. Study Identification

Unique Protocol Identification Number
NCT03003806
Brief Title
Evaluation of the Dreamed Advisor Pro for Automated Insulin Pump Setting Adjustments in Children and Adolescents With Type 1 Diabetes- The Advice4U Pro Study
Acronym
Advice4U
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
Study Type
Interventional

2. Study Status

Record Verification Date
June 2019
Overall Recruitment Status
Completed
Study Start Date
October 2, 2017 (Actual)
Primary Completion Date
November 10, 2019 (Actual)
Study Completion Date
November 10, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Rabin Medical Center
Collaborators
DreaMed, The Leona M. and Harry B. Helmsley Charitable Trust

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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: A statistical analysis of the insulin pump and sensor data: insulin delivery, bolus-calculator rate of use, sensor glucose variables, hypoglycemic and hyperglycemia patterns. Practical recommendations, alert messages based on aforementioned data 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type1 Diabetes Mellitus
Keywords
Insulin pump treatment, Type 1 diabetes, Pump setting advisor

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
122 (Actual)

8. Arms, Groups, and Interventions

Arm Title
DreaMed Advisor Pro
Arm Type
Experimental
Arm Description
Insulin pump settings (i.e, basal plan, correction factor, carbohydrate ratio and insulin activity time) will be adjusted using the DreaMed Advisor Pro
Arm Title
Control group-medical guided recommendations
Arm Type
Active Comparator
Arm Description
Insulin pump settings (i.e, basal plan, correction factor, carbohydrate ratio and insulin activity time) will be adjusted by the medical team
Intervention Type
Device
Intervention Name(s)
DreaMed Advisor Pro
Intervention Description
Insulin pump settings (i.e, basal plan, correction factor, carbohydrate ratio and insulin activity time) will be adjusted using the DreaMed Advisor Pro
Intervention Type
Other
Intervention Name(s)
Medical guided recommendation
Intervention Description
Insulin pump settings (i.e, basal plan, correction factor, carbohydrate ratio and insulin activity time) will be adjusted by the medical team
Primary Outcome Measure Information:
Title
Percentage of glucose readings within range of 70-180 mg/dl (3.9 to 10 mmol/l).
Time Frame
Final visit (week 31)
Title
Percentage of glucose readings below 54 mg/dl (3.3 mmol/l)
Time Frame
Final visit (week 31)
Secondary Outcome Measure Information:
Title
HbA1c
Time Frame
Final visit (week 31)
Title
Percentage of glucose readings below 70 mg/dl (3.9 mmol/L)
Time Frame
Final visit (week 31)
Title
Percentage of readings below 50 mg/dl (2.8 mmol/L)
Time Frame
Final visit (week 31)
Title
Percentage of readings above 180 mg/dl (10.0 mmol/L)
Time Frame
Final visit (week 31)
Title
Percentage of readings above 240 mg/dl (13.3 mmol/L)
Time Frame
Final visit (week 31)
Title
Area above the curve of glucose glucose level of 180 mg/dl
Time Frame
Final visit (week 31)
Title
Area under the curve of glucose level of 70 mg/dl
Time Frame
Final visit (week 31)
Title
Mean sensor blood glucose
Time Frame
Final visit (week 31)
Title
Glucose variability measured by Standard Deviation
Time Frame
Final visit (week 31)
Title
Number of recommendations for changes in settings per patient
Time Frame
Final visit (week 31)
Title
Number of recommendations for changes in settings per iteration
Time Frame
Final visit (week 31)
Title
Number of physician override Advisor recommendations
Time Frame
Final visit (week 31)
Title
Number of patients overrides of recommendation
Time Frame
Final visit (week 31)
Title
Estimated time duration needed for the physician to give its recommendations
Time Frame
Final visit (week 31)
Title
Device satisfaction questionaire
Time Frame
Final visit (week 31)
Title
Diabetes treatment satisfaction questionnaire
Time Frame
Final visit (week 31)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
10 Years
Maximum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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) Exclusion Criteria: 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
Facility Information:
Facility Name
Barbara Davis Center for Childhood Diabetes
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045-6511
Country
United States
Facility Name
Yale University School of Medicine
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06520-8064
Country
United States
Facility Name
University of Florida College of Medicine
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32610
Country
United States
Facility Name
Joslin Diabetes Center, One Joslin Place
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
Diabetes -Zentrum fuer kinder und jugendliche
City
Hannover
Country
Germany
Facility Name
Schnider children's medical center
City
Petach-Tikva
ZIP/Postal Code
49202
Country
Israel
Facility Name
University Children's Hospital
City
Ljubljana
Country
Slovenia

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
32908282
Citation
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.
Results Reference
derived

Learn more about this trial

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

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