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

NCT ID: NCT03574558

Last Updated: 2019-12-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 28 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-08-01
• Study Completion Date: 2019-11-25

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.

Conditions

Type1diabetes

Study Design

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

Study Groups

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

Group Type: EXPERIMENTAL

MD-Logic Switch Advisor

Intervention Type: DEVICE

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

Interventions

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

Intervention Type: DEVICE

Eligibility 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)

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 30 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Juvenile Diabetes Research Foundation

OTHER

Sponsor Role: collaborator

Jaeb Center for Health Research

OTHER

Sponsor Role: collaborator

DreaMed

INDUSTRY

Sponsor Role: collaborator

University of Padova

OTHER

Sponsor Role: collaborator

Rabin Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Schnider children's medical center

Petah Tikva, , Israel

Countries

Israel

Other Identifiers

RMC0409-18ctil

Identifier Type: -

Identifier Source: org_study_id