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

Type1 Diabetes Mellitus Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03003806
• Other study ID #: RMC072016ctil
• Status: Completed
• Phase: N/A
• Start date: October 2, 2017
• Est. completion date: November 10, 2019

Study information

• Verified date: June 2019
• Source: Rabin Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 122
• Est. completion date: November 10, 2019
• Est. primary completion date: November 10, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 10 Years to 21 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Type1 Diabetes Mellitus

Intervention

Device:
• 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

Other:
• 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

Locations

Country	Name	City	State
Germany	Diabetes -Zentrum fuer kinder und jugendliche	Hannover
Israel	Schnider children's medical center	Petach-Tikva
Slovenia	University Children's Hospital	Ljubljana
United States	Barbara Davis Center for Childhood Diabetes	Aurora	Colorado
United States	Joslin Diabetes Center, One Joslin Place	Boston	Massachusetts
United States	University of Florida College of Medicine	Gainesville	Florida
United States	Yale University School of Medicine	New Haven	Connecticut

Sponsors (3)

Lead Sponsor	Collaborator
Rabin Medical Center	DreaMed, The Leona M. and Harry B. Helmsley Charitable Trust

Countries where clinical trial is conducted

United States,  Germany,  Israel,  Slovenia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of glucose readings within range of 70-180 mg/dl (3.9 to 10 mmol/l).		Final visit (week 31)
Primary	Percentage of glucose readings below 54 mg/dl (3.3 mmol/l)		Final visit (week 31)
Secondary	HbA1c		Final visit (week 31)
Secondary	Percentage of glucose readings below 70 mg/dl (3.9 mmol/L)		Final visit (week 31)
Secondary	Percentage of readings below 50 mg/dl (2.8 mmol/L)		Final visit (week 31)
Secondary	Percentage of readings above 180 mg/dl (10.0 mmol/L)		Final visit (week 31)
Secondary	Percentage of readings above 240 mg/dl (13.3 mmol/L)		Final visit (week 31)
Secondary	Area above the curve of glucose glucose level of 180 mg/dl		Final visit (week 31)
Secondary	Area under the curve of glucose level of 70 mg/dl		Final visit (week 31)
Secondary	Mean sensor blood glucose		Final visit (week 31)
Secondary	Glucose variability measured by Standard Deviation		Final visit (week 31)
Secondary	Number of recommendations for changes in settings per patient		Final visit (week 31)
Secondary	Number of recommendations for changes in settings per iteration		Final visit (week 31)
Secondary	Number of physician override Advisor recommendations		Final visit (week 31)
Secondary	Number of patients overrides of recommendation		Final visit (week 31)
Secondary	Estimated time duration needed for the physician to give its recommendations		Final visit (week 31)
Secondary	Device satisfaction questionaire		Final visit (week 31)
Secondary	Diabetes treatment satisfaction questionnaire		Final visit (week 31)