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

Diabetes Mellitus, Type 1 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04043260
• Other study ID #: CR-0998
• Status: Completed
• Phase: N/A
• Start date: November 27, 2019
• Est. completion date: April 30, 2021

Study information

• Verified date: August 2021
• Source: DreaMed Diabetes
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: April 30, 2021
• Est. primary completion date: February 28, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Insulin-dependent Diabetes Mellitus

Intervention

Device:
• 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).

Locations

Country	Name	City	State
Israel	Schneider MC	Petah Tikva

Sponsors (1)

Lead Sponsor	Collaborator
DreaMed Diabetes

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	9 weeks
Secondary	Percentage of readings within range of 70-180 mg/dl		9 weeks
Secondary	Change in HbA1C post study treatment		9 weeks