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

Primary Purpose

Type 1 Diabetes

Status
Recruiting
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
DreaMed Advisor Pro
Sponsored by
Rabin Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Type 1 Diabetes focused on measuring Decision Support System, Type 1 Diabetes

Eligibility Criteria

6 Years - 65 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Schnider Children's Medical CenterRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

DreaMed Advisor Pro

Arm Description

Using the DreaMed Advisor Pro as an advisory tool for Health Care Professionals during routine clinical use

Outcomes

Primary Outcome Measures

HbA1c

Secondary Outcome Measures

Percentage of glucose readings within target range of 70-180 mg/dl
Percentage of glucose sensor readings below 54 mg/dl
Percentage of glucose sensor readings above 250 mg/dl
Percentage of glucose sensor readings 70-54 mg/dl
Percentage of glucose sensor readings 180-250 mg/dl
Mean sensor glucose
Glucose variability
Total insulin dose
Total basal insulin dose
Total Bolus insulin dose
Total daily consumed carbohydrates

Full Information

First Posted
February 9, 2020
Last Updated
August 8, 2022
Sponsor
Rabin Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT04271228
Brief Title
Use of Insulin Adjustment Device DreaMed Advisor Pro During Routine Clinical Use for Subjects With Diabetes Type 1
Official Title
Use of Insulin Adjustment Device DreaMed Advisor Pro During Routine Clinical Use for Subjects With Diabetes Type 1
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Recruiting
Study Start Date
February 15, 2020 (Actual)
Primary Completion Date
August 26, 2023 (Anticipated)
Study Completion Date
August 26, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Rabin Medical Center

4. Oversight

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

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 (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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 1 Diabetes
Keywords
Decision Support System, Type 1 Diabetes

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
DreaMed Advisor Pro
Arm Type
Experimental
Arm Description
Using the DreaMed Advisor Pro as an advisory tool for Health Care Professionals during routine clinical use
Intervention Type
Device
Intervention Name(s)
DreaMed Advisor Pro
Intervention Description
Using the DreaMed Advisor Pro as an advisory tool for Health Care Professionals during routine clinical use
Primary Outcome Measure Information:
Title
HbA1c
Time Frame
Through study completion , an average of 1 year
Secondary Outcome Measure Information:
Title
Percentage of glucose readings within target range of 70-180 mg/dl
Time Frame
Through study completion, an average of 1 year
Title
Percentage of glucose sensor readings below 54 mg/dl
Time Frame
Through study completion, an average of 1 year
Title
Percentage of glucose sensor readings above 250 mg/dl
Time Frame
Through study completion, an average of 1 year
Title
Percentage of glucose sensor readings 70-54 mg/dl
Time Frame
Through study completion, an average of 1 year
Title
Percentage of glucose sensor readings 180-250 mg/dl
Time Frame
Through study completion, an average of 1 year
Title
Mean sensor glucose
Time Frame
Through study completion, an average of 1 year
Title
Glucose variability
Time Frame
Through study completion, an average of 1 year
Title
Total insulin dose
Time Frame
Through study completion, an average of 1 year
Title
Total basal insulin dose
Time Frame
Through study completion, an average of 1 year
Title
Total Bolus insulin dose
Time Frame
Through study completion, an average of 1 year
Title
Total daily consumed carbohydrates
Time Frame
Through study completion, an average of 1 year
Other Pre-specified Outcome Measures:
Title
Number of recommendations for changes in the treatment plan per patient
Time Frame
Through study completion, an average of 1 year
Title
Number of physician overrides of advisor recommendations
Time Frame
Through study completion, an average of 1 year
Title
Device satisfaction
Description
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.
Time Frame
at the end of the intervention period (1 year)
Title
Frequency of home phone visits
Time Frame
Through study completion, an average of 1 year
Title
Time required to review insulin pump and sensor data, make and send recommendations or length of visit
Description
will be measured by timer
Time Frame
Through study completion, an average of 1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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: Subject has unstable or rapidly progressive renal disease or is receiving dialysis Subject has active proliferative retinopathy 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Revital Nimri, MD
Phone
972-3-9253282
Email
ravitaln@clalit.org.il
First Name & Middle Initial & Last Name or Official Title & Degree
Alona Hamou, Msc
Phone
972-3-9253282
Email
alonah@clalit.org.il
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Revital Nimri, MD
Organizational Affiliation
Schneider Children;s Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Schnider Children's Medical Center
City
Petach-Tikva
ZIP/Postal Code
4920235
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Revital Nimri, MD
Phone
972-3-9253282
Email
Ravitaln@clalit.org.il
First Name & Middle Initial & Last Name & Degree
Alona Hamou, Msc
Phone
972-3-9253282
Email
alonah@clali.org.il

12. IPD Sharing Statement

Learn more about this trial

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

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