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DreaMed Advisor Pro System in Subjects With Type 1 Diabetes Treated With MDI Therapy

Primary Purpose

Insulin-dependent Diabetes Mellitus, Diabetes Mellitus, Type 1

Status

Completed

Phase

Not Applicable

Locations

Israel

Study Type

Interventional

Intervention

Advisor Pro

About this trial

This is an interventional treatment trial for Insulin-dependent Diabetes Mellitus focused on measuring Diabetes Type 1, Multiple Daily Injections

Eligibility Criteria

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

Inclusion Criteria:

Documented T1D for at least 1 year prior to study enrolment
Subjects aged 18 - 65 years old
A1c at inclusion ≤ 10%
Subjects using basal-bolus MDI therapy:
1. Basal insulin: Glargine, Degludec, or Determir
2. Bolus insulin: regular insulin, rapid analogues or ultra-rapid analogues
Subjects using CGM or SMBG that are compatible with data transmission to the study DMS.
BMI < 28 kg/m2
Subjects willing to follow study instructions:
1. For SMBG users: measure capillary blood glucose at least 4 times a day and twice a week 7-point profile (optional). Document blood glucose level, insulin delivery, meals and daily activities. Wear blinded CGM.
2. For CGM users: Use CGM according to manufacture instructions, Document insulin delivery, meals and daily activities.
Subjects have connection to the internet at home.
Subjects have a smartphone compatible with study requirements
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 patients' 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.
Drug or alcohol abuse.

Sites / Locations

Schneider MC

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Intervention

Arm Description

Subject's glucose and insulin data will be transferred to the DreaMed Advisor Pro system. Optimization of insulin treatment plan will be done using the DreaMed Advisor Pro algorithm. After approval by the study physician (may override the suggestions for safety reasons), the treatment plan will be sent to the subject to be followed for the following 3 weeks. The study team will follow-up with a phone call to the subject to verify the subject received the updated treatment plan.

Outcomes

Primary Outcome Measures

Percentage of readings below 54 mg/dl

Compare percentage of readings below 54 mg/dl during 3 weeks run-in period to percentage of readings below 54 mg/dl during intervention period.

Secondary Outcome Measures

Percentage of readings within range of 70-180 mg/dl

Change in HbA1C post study treatment

Full Information

NCT ID

NCT04043260

First Posted

July 31, 2019

Last Updated

August 16, 2021

Sponsor

DreaMed Diabetes

1. Study Identification

Unique Protocol Identification Number

NCT04043260

Brief Title

DreaMed Advisor Pro System in Subjects With Type 1 Diabetes Treated With MDI Therapy

Official Title

Evaluation of the DreaMed Advisor Pro System in Subjects With Type 1 Diabetes Treated With Multiple Daily Injections of Insulin

Study Type

Interventional

2. Study Status

Record Verification Date

August 2021

Overall Recruitment Status

Completed

Study Start Date

November 27, 2019 (Actual)

Primary Completion Date

February 28, 2021 (Actual)

Study Completion Date

April 30, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

DreaMed Diabetes

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

5. Study Description

Brief Summary

A multi center, open label, prospective study that will include up to 100 subjects with Type 1 Diabetes treated with Multiple Daily Injections (MDI) of insulin according to a predefined sliding scale plan or carbohydrate ratio (CR) and correction factor (CF) plan, and Self-Monitoring of Blood Glucose (SMBG) or Continuous Glucose Monitoring (CGM). The study will include screening, a 3-4 weeks run-in period and a 6 weeks intervention period. Subjects will be asked to record their insulin delivery during basal/bolus insulin treatment (using dedicated apps and/or connected pens) and their daily activities (meals, physical activity etc.) using electronic log (implemented on Dedicated Apps), for a total period of 9-10 weeks.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Insulin-dependent Diabetes Mellitus, Diabetes Mellitus, Type 1

Keywords

Diabetes Type 1, Multiple Daily Injections

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

35 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Intervention

Arm Type

Experimental

Arm Description

Intervention Type

Device

Intervention Name(s)

Advisor Pro

Intervention Description

The DreaMed Advisor Pro software is a proprietary algorithm, designed to provide a comprehensive analysis of individual diabetes data which consists of glucose levels and insulin delivery history. the Advisor Pro algorithm identifies glucose patterns and their possible causes, which may hamper the patient's glucose control, and recommend on adjustment to the patient-specific insulin treatment profiles as well as suggestions for personalized diabetes management tips (such as timing of meal boluses, bolus delivery compliance and personalized glucose targets).

Primary Outcome Measure Information:

Title

Percentage of readings below 54 mg/dl

Description

Compare percentage of readings below 54 mg/dl during 3 weeks run-in period to percentage of readings below 54 mg/dl during intervention period.

Time Frame

9 weeks

Secondary Outcome Measure Information:

Title

Percentage of readings within range of 70-180 mg/dl

Time Frame

9 weeks

Title

Change in HbA1C post study treatment

Time Frame

9 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Documented T1D for at least 1 year prior to study enrolment Subjects aged 18 - 65 years old A1c at inclusion ≤ 10% Subjects using basal-bolus MDI therapy: Basal insulin: Glargine, Degludec, or Determir Bolus insulin: regular insulin, rapid analogues or ultra-rapid analogues Subjects using CGM or SMBG that are compatible with data transmission to the study DMS. BMI < 28 kg/m2 Subjects willing to follow study instructions: For SMBG users: measure capillary blood glucose at least 4 times a day and twice a week 7-point profile (optional). Document blood glucose level, insulin delivery, meals and daily activities. Wear blinded CGM. For CGM users: Use CGM according to manufacture instructions, Document insulin delivery, meals and daily activities. Subjects have connection to the internet at home. Subjects have a smartphone compatible with study requirements 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 patients' 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. Drug or alcohol abuse.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Yael Shtrit

Organizational Affiliation

DreaMed Diabetes Ltd.

Official's Role

Study Director

Facility Information:

Facility Name

Schneider MC

City

Petah Tikva

Country

Israel

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

DreaMed Advisor Pro System in Subjects With Type 1 Diabetes Treated With MDI Therapy

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