Clinical trial NCT04043260: 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
Overall status: COMPLETED
Phase: NA
Conditions: Insulin-dependent Diabetes Mellitus
Diabetes Mellitus, Type 1
Keywords: Diabetes Type 1
Multiple Daily Injections
Lead sponsor: DreaMed Diabetes
Sponsor class: INDUSTRY
First posted: 2019-08-02
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Percentage of readings below 54 mg/dl
timeFrame: 9 weeks
Secondary outcomes:
measure: Percentage of readings within range of 70-180 mg/dl
timeFrame: 9 weeks
measure: Change in HbA1C post study treatment
timeFrame: 9 weeks
Other outcomes:
Locations:
city: Petah Tikva
country: Israel
facility: Schneider MC
Study officials:
affiliation: DreaMed Diabetes Ltd.
name: Yael Shtrit
role: STUDY_DIRECTOR
References: