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Trial record 10 of 2461 for:    Diabetes | "Diabetes Mellitus, Insulin-Dependent"

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

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ClinicalTrials.gov Identifier: NCT04043260
Recruitment Status : Not yet recruiting
First Posted : August 2, 2019
Last Update Posted : August 2, 2019
Sponsor:
Information provided by (Responsible Party):
DreaMed Diabetes

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.


Condition or disease Intervention/treatment Phase
Insulin-dependent Diabetes Mellitus Diabetes Mellitus, Type 1 Device: Advisor Pro Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Evaluation of the DreaMed Advisor Pro System in Subjects With Type 1 Diabetes Treated With Multiple Daily Injections of Insulin
Estimated Study Start Date : September 8, 2019
Estimated Primary Completion Date : January 2020
Estimated Study Completion Date : January 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diabetes Type 1
Drug Information available for: Insulin

Arm Intervention/treatment
Experimental: 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.
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).




Primary Outcome Measures :
  1. Percentage of readings below 54 mg/dl [ Time Frame: 9 weeks ]
    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 :
  1. Percentage of readings within range of 70-180 mg/dl [ Time Frame: 9 weeks ]
  2. Change in HbA1C post study treatment [ Time Frame: 9 weeks ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04043260


Contacts
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Contact: Yael Shtrit +972-502428305 yael.shtrit@dreamed-diabetes.com

Locations
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Israel
Schneider MC Not yet recruiting
Petah Tikva, Israel
Contact: Alona       alonah@clalit.org.il   
Sponsors and Collaborators
DreaMed Diabetes
Investigators
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Study Director: Yael Shtrit DreaMed Diabetes Ltd.

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Responsible Party: DreaMed Diabetes
ClinicalTrials.gov Identifier: NCT04043260     History of Changes
Other Study ID Numbers: CR-0998
First Posted: August 2, 2019    Key Record Dates
Last Update Posted: August 2, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by DreaMed Diabetes:
Diabetes Type 1
Multiple Daily Injections
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs