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Personalized Automated Determination of Insulin Pump Setting for Subjects With Type 1 Diabetes Switching From MDI to Pump Therapy and Vice Versa- Safety and Efficacy Feasibility Study

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ClinicalTrials.gov Identifier: NCT03574558
Recruitment Status : Recruiting
First Posted : July 2, 2018
Last Update Posted : January 8, 2019
Sponsor:
Collaborators:
Juvenile Diabetes Research Foundation
Jaeb Center for Health Research
DreaMed
University of Padova
Information provided by (Responsible Party):
Rabin Medical Center

Brief Summary:

The "MD-Logic Switch Advisor" is a software product that is designed to assist in insulin dosage decision making and has two components:

A. MD-Logic Switch Advisor for initiation of pump therapy - this product is designed to assist physicians in decision making when initiating insulin pump therapy.

B. MD-Logic Switch Advisor for patients who use insulin pump therapy and need to switch to MDI (Multiple Daily Injections).

This feasibility study will be divided to two parts:

part A - will include up to 20 patients to evaluate in a feasibility study the switch Advisor from MDI to pump therapy part B - will include up to 20 patients to evaluate in a feasibility study the switch Advisor from pump therapy to MDI The main objective is to evaluate the safety and efficacy of using the MD-Logic Switch Advisor to determine insulin dosing for subjects with type 1 diabetes using pump therapy who wish to switch to from pump to MDI therapy and vice versa.


Condition or disease Intervention/treatment Phase
Type1diabetes Device: MD-Logic Switch Advisor Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Personalized Automated Determination of Insulin Pump Setting for Subjects With Type 1 Diabetes Switching From MDI to Pump Therapy and Vice Versa- Safety and Efficacy Feasibility Study
Actual Study Start Date : August 1, 2018
Estimated Primary Completion Date : April 15, 2019
Estimated Study Completion Date : April 15, 2019

Resource links provided by the National Library of Medicine

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

Arm Intervention/treatment
Experimental: MD-Logic Switch Advisor
MD-Logic Switch Advisor Algorithm for personalized automated determination of insulin pump settings for subjects with type 1 diabetes switching from MDI to pump therapy and vice versa
Device: MD-Logic Switch Advisor
Study algorithm will be used in order to determine the initial pump setting/ MDI dosing while switching from from MDI to pump therapy or vice versa




Primary Outcome Measures :
  1. Number of hypoglycemic below 54 mg/dl [ Time Frame: Day 14 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   6 Years to 30 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. The subject has documented Type 1 Diabetes Mellitus, as defined by the American Diabetes Association and World Health Organization (ADA/WHO) for at least 3 months prior to study enrolment ( Part A of the study) or at least 6 months (Part B of the study)
  2. Insulin dose requirement is equal or above 0.5/unit/kg
  3. The subject age is ≥ 6 years and below 30 years at the time of enrolment
  4. A1c < 10%
  5. The subject uses multiple daily injections to deliver insulin and wish to switch to pump therapy (Part A of the study) or the subject uses pump therapy for at least 3 months and is willing to switch to multiple daily injections for the study period (Part B of the study)
  6. The subject is willing to follow study instructions
  7. Subject is available for entire study duration

Exclusion Criteria:

  1. 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 patient's safety, or that influence metabolic control (e.g. anemia, significantly impaired hepatic function, renal failure, history of adrenal insufficiency).
  2. Subject is taking or has taken oral or parenteral glucocorticoids within 1 month prior to screening or plans to take oral or parenteral glucocorticoids within the planned study duration. Exceptions: Short term oral or paraenteral glucocorticoids up to 7 days
  3. Subject has known allergy to medical grade adhesives
  4. Subject is participating in another study of a medical device or drug that could affect glucose measurements or glucose management or receipt of any investigational medical product within 1 month prior to screening (visit1)
  5. Female subject of child-bearing potential who have a positive pregnancy test at screening, is pregnant, breast-feeding, or planning to become pregnant within the planned study duration (or is not using adequate contraceptive methods)
  6. Subject diagnosed with current eating disorder such as anorexia or bulimia
  7. Subject has a history of one or more episodes of Diabetes Keto-acidosis requiring hospitalization within a 3 months prior to screening
  8. Subject has visual impairment or hearing loss, which in the Investigator's opinion, may compromise patient ability to perform study procedures safely (child and parent should be evaluated as a unit)

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): NCT03574558


Contacts
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Contact: Revital Nimri, MD 972-3-92532382 Ravitaln@clalit.org.il
Contact: Alona Hamou, Msc 972-3-9253282 alonah@clalit.org.il

Locations
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Israel
Schnider children's medical center Recruiting
Petach-Tikva, Israel, 49202
Contact: Revital Nimri, MD    972-3-9253778    Ravitaln@clalit.org.il   
Sub-Investigator: Liat De Vries, Dr.         
Sub-Investigator: Liora Lazar, Dr.         
Sub-Investigator: Tal Oron, Dr.         
Sub-Investigator: Ariel Tenennbaum, Dr.         
Sub-Investigator: Shlomit Shalitin, Dr.         
Sub-Investigator: Sari Karpel, Dr         
Sub-Investigator: Sharon Demol, Dr         
Sub-Investigator: Rachel Bello, Dr         
Sub-Investigator: Michal Nevo, Dr         
Sub-Investigator: Marie Muller, Dr         
Sponsors and Collaborators
Rabin Medical Center
Juvenile Diabetes Research Foundation
Jaeb Center for Health Research
DreaMed
University of Padova

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Responsible Party: Rabin Medical Center
ClinicalTrials.gov Identifier: NCT03574558     History of Changes
Other Study ID Numbers: RMC0409-18ctil
First Posted: July 2, 2018    Key Record Dates
Last Update Posted: January 8, 2019
Last Verified: January 2019

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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 Rabin Medical Center:
Pump therapy
Multiple Daily Injections (MDI)
Decision Support System (DSS)

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