Use of Insulin Adjustment Device DreaMed Advisor Pro During Routine Clinical Use for Subjects With Diabetes Type 1

The DreaMed Advisor Pro, is a software which automatically analyses treatment information, learns patient's needs and accordingly suggests adjustments in insulin dosing (FDA approved decision support system). The 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 for health care professionals and has three main components: First, data analysis report - a statistical analysis of the insulin pump and sensor data: insulin delivery, bolus-calculator rate of use, sensor glucose variables, hypoglycemic and hyperglycemic patterns. Second, recommendations, alert messages based on aforementioned data for example "pay attention- you skipped boluses", basal/bolus ratio is too high, bolus delivery compliance, glucose target recommendations and more. Third, a 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 Advisor Pro can be used to optimize insulin pump setting during clinical visits, in-between visits or as part of virtual (telemedicine) visit. The objective of the proposed study is to evaluate the use of Advisor Pro by Health Care Providers for regular clinical visits and in between visits titration for adjustment of insulin pump settings. The study design is an open label, prospective, observational study that will include up to 100 participants with Type 1 Diabetes using insulin pumps and monitoring glucose levels by continuous glucose monitoring including flash glucose monitoring.

Study Overview

• Status: Completed
• Conditions: Type 1 Diabetes
• Intervention / Treatment: Device: DreaMed Advisor Pro

• Study Type: Interventional
• Enrollment (Actual): 70
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Israel
  • Petach-Tikva, Israel, 4920235
    • Schnider Children's medical center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 years to 65 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Documented Type 1 Diabetes for at least 1 year prior to study enrolment
• Subjects aged 6 - 65 years old
• HbA1c at inclusion ≤ 10%
• Subjects using Insulin pump therapy for at least 4 months
• Subjects using Insulin pump compatible with data transmission to the study Tidepool/Glooko Data Managment System (DMS) - Omnipod, Medtronic
• Subjects using Continuous Glucose Monitoring (CGM) System that is compatible with data transmission to the study Tidepool/Glooko DMS - Dexcom, Libre, Medtronic.
• Subjects willing to follow study instructions: Use CGM according to manufacture instructions, use the bolus-wizard feature of the insulin pump for every meal and correction boluses.
• Subjects have home PC or MAC connected to the internet.
• Subjects willing and able to sign a written informed consent form.

Exclusion Criteria:

• An episode of diabetic keto-acidosis within the month prior to study entry and/or severe hypoglycemia resulting in seizure or loss of consciousness in the month prior to enrolment.
• Concomitant diseases/ treatment that influence metabolic control or 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.

• Relevant severe organ disorders (diabetic nephropathy, diabetic retinopathy, diabetic foot syndrome) or any secondary disease or complication of diabetes mellitus, such as:

  1. Subject has unstable or rapidly progressive renal disease or is receiving dialysis
  2. Subject has active proliferative retinopathy
  3. Active gastroparesis
• Participation in any other interventional study
• Female subject who is pregnant or planning to become pregnant within the planned study duration
• Subject is in the "honeymoon" phase - i.e. less than 0.5 insulin units/kg per day.
• Known or suspected allergy to trial products
• Drug or alcohol abuse

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: DreaMed Advisor Pro; Using the DreaMed Advisor Pro as an advisory tool for Health Care Professionals during routine clinical use	Device: DreaMed Advisor Pro; Using the DreaMed Advisor Pro as an advisory tool for Health Care Professionals during routine clinical use

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
HbA1c	Through study completion , an average of 1 year

Secondary Outcome Measures

Outcome Measure	Time Frame
Percentage of glucose readings within target range of 70-180 mg/dl	Through study completion, an average of 1 year
Percentage of glucose sensor readings below 54 mg/dl	Through study completion, an average of 1 year
Percentage of glucose sensor readings above 250 mg/dl	Through study completion, an average of 1 year
Percentage of glucose sensor readings 70-54 mg/dl	Through study completion, an average of 1 year
Percentage of glucose sensor readings 180-250 mg/dl	Through study completion, an average of 1 year
Mean sensor glucose	Through study completion, an average of 1 year
Glucose variability	Through study completion, an average of 1 year
Total insulin dose	Through study completion, an average of 1 year
Total basal insulin dose	Through study completion, an average of 1 year
Total Bolus insulin dose	Through study completion, an average of 1 year
Total daily consumed carbohydrates	Through study completion, an average of 1 year

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of recommendations for changes in the treatment plan per patient		Through study completion, an average of 1 year
Number of physician overrides of advisor recommendations		Through study completion, an average of 1 year
Device satisfaction	Device satisfaction evaluated by Healthcare Professionals Survey containing 50 items, Device satisfaction evaluated by Healthcare Professionals Survey containing 50 items, 28 of them are on 5-point scale ranging from "strongly agree" to "strongly disagree", 10 items are "yes"/ "no" questions and 12 items are opened questions.	at the end of the intervention period (1 year)
Frequency of home phone visits		Through study completion, an average of 1 year
Time required to review insulin pump and sensor data, make and send recommendations or length of visit	will be measured by timer	Through study completion, an average of 1 year

Collaborators and Investigators

• Sponsor: Rabin Medical Center
• Investigators: Principal Investigator: Revital Nimri, MD, Schneider Children;s Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): February 15, 2020
• Primary Completion (Actual): January 19, 2022
• Study Completion (Actual): January 19, 2022

Study Registration Dates

• First Submitted: February 9, 2020
• First Submitted That Met QC Criteria: February 13, 2020
• First Posted (Actual): February 17, 2020

Study Record Updates

• Last Update Posted (Actual): March 26, 2024
• Last Update Submitted That Met QC Criteria: March 25, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: Type 1 Diabetes; Decision Support System
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Immune System Diseases; Autoimmune Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 1
• Other Study ID Numbers: RMC0525-19ctil

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No