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

NCT ID: NCT04043260

Last Updated: 2021-08-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 35 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-11-27
• Study Completion Date: 2021-04-30

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.

Conditions

Insulin-dependent Diabetes Mellitus; Diabetes Mellitus, Type 1

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Intervention

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.

Group Type: EXPERIMENTAL

Advisor Pro

Intervention Type: DEVICE

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).

Interventions

Advisor Pro

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).

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

1. Documented T1D for at least 1 year prior to study enrolment

2. Subjects aged 18 - 65 years old

3. A1c at inclusion ≤ 10%

4. Subjects using basal-bolus MDI therapy:

1. Basal insulin: Glargine, Degludec, or Determir

2. Bolus insulin: regular insulin, rapid analogues or ultra-rapid analogues

5. Subjects using CGM or SMBG that are compatible with data transmission to the study DMS.

6. BMI < 28 kg/m2

7. 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.

8. Subjects have connection to the internet at home.

9. Subjects have a smartphone compatible with study requirements

10. Subjects willing and able to sign a written informed consent form.

Exclusion Criteria

1. 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.

2. 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

3. 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

4. Participation in any other interventional study

5. Female subject who is pregnant or planning to become pregnant within the planned study duration

6. Subject is in the "honeymoon" phase - i.e. less than 0.5 insulin units/kg per day.

7. Drug or alcohol abuse.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

DreaMed Diabetes

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Yael Shtrit

Role: STUDY_DIRECTOR

DreaMed Diabetes Ltd.

Locations

Schneider MC

Petah Tikva, , Israel

Countries

Israel

Other Identifiers

CR-0998

Identifier Type: -

Identifier Source: org_study_id