Determination of Automated Multiple Insulin Dose Injections Settings Using the MDI/SMBG Advisor for Patients With Type 1 Diabetes -Data Collection, Observational & Proof of Concept Study

November 29, 2020 updated by: Rabin Medical Center

The MDI (Multiple Daily Injections) plus SMBG |(Self Monitoring Blood Glucose) Advisor (MPSA) is a software product that is designed to assist in insulin dosage decision making for subjects with T1DM using multiple daily injection and SMBG.

The study will focus on the development, validation and eventually testing of the MPSA algorithm use. The major objective of the project is to develop an algorithm that will be able to optimize treatment plan parameters of MDI patients who use SMBG as glucose monitoring method. The clinical study has two segments. Segment A is an observational study needed for the development of the algorithm (this segment was already completed at the time of the registration) and Segment B is a proof of concept interventional study to validate the algorithm's Safety and Efficacy.

Up to 20 patients using MDI and SMBG or Flash Glucose Monitoring (FGM) without using glucose trends will be enrolled to this proof of concept study. The study will evaluate the algorithm use for a period of 11 weeks. Post screening, patients will undergo a two weeks run-in period while using MDI and SMBG or FGM (patients that do not use FGM will be provided with blinded Libre Flash to be used during the run-in period and 2 weeks prior to arriving to end of study visit). Then, patients will undergo insulin treatment plan changes every week for 7 weeks. At the first 3 weeks insulin dose adjustments will be done for basal insulin dose only, week 4 will be without changes, and in the next 3 weeks the carbohydrate ratio will be amended. No recommendations will be given during the last two weeks of the study. These two weeks will be used for data analysis. Each recommendation of the Advisor will be approved by a physician before implementation. Glucose outcomes will be evaluated comparing the two weeks run-in period to the last two weeks of the study.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
6

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Petach-Tikva, Israel
        • Schnider children medical center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years to 30 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Documented T1D for at least 1 year prior to study enrolment
  • Subjects aged ≥ 14 years and up to 30 years
  • A1c at inclusion ≥ 7 % and ≤ 10%
  • Using MDI of Basal/bolus therapy - basal insulin either Glargine/Lantus or Tregludec insulin and bolus short acting insulin analogs either aspart/Novorapid or Lispro/Humalog
  • Using SMBG or flash glucose monitoring (FGM/Libre) without using glucose trends
  • BMI SDS - below the 97th percentile for age
  • Subjects willing to follow study instructions

Exclusion Criteria:

  • 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
  • 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 patient's safety
  • Participation in any other interventional study
  • Known or suspected allergy to trial products
  • Female subject who is pregnant or planning to become pregnant within the planned study duration
  • Subject needs to travel by air during the study duration

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: MPSA Algorithm
Insulin dosing will be adjusted using the MPSA algorithm
Device: MPSA Algorithm
Insulin dosing will be adjusted using the MPSA Algorithm

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Percentage of sensor glucose readings within range of 70-180 mg/dl
Time Frame: Final visit (day 42)
Final visit (day 42)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Percentage of sensor glucose readings below 54 mg/dl
Time Frame: Final visit (day 42)
Final visit (day 42)
HbA1c
Time Frame: Final visit (day 42)
Final visit (day 42)
Number of Severe Hypoglycemia events
Time Frame: Final visit (day 42)
Final visit (day 42)
Number of Diabetic Ketoacidosis events
Time Frame: Final visit (day 42)
Final visit (day 42)

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Time Frame
Percentage of sensor glucose readings below 70 mg/dl
Time Frame: Final visit (day 42)
Final visit (day 42)
Percentage of sensor glucose readings below 50mg/dl
Time Frame: Final visit (day 42)
Final visit (day 42)
Percentage of sensor glucose readings above 180mg/dl
Time Frame: Final visit (day 42)
Final visit (day 42)
Percentage of sensor glucose readings above 250mg/dl
Time Frame: Final visit (day 42)
Final visit (day 42)
Number of unexplained hyperglycemic events
Time Frame: Final visit (day42)
Final visit (day42)
Area above the curve of 180mg/dl
Time Frame: Final visit (day 42)
Final visit (day 42)
Area above the curve >180mg/dl
Time Frame: Final visit (day 42)
Final visit (day 42)
Area under the curve of 70mg/dl
Time Frame: Final visit (day 42)
Final visit (day 42)
Area under the curve <70mg/dl
Time Frame: Final visit (day 42)
Final visit (day 42)
Mean sensor blood glucose
Time Frame: Final visit (day42)
Final visit (day42)
Glucose variability measured by SD (standard deviation)
Time Frame: Final visit (day 42)
Final visit (day 42)
Number of recommendations for changes in settings per patient
Time Frame: Final visit (day 42)
Final visit (day 42)
Number of recommendations for changes in setting per iteration
Time Frame: Final visit (day 42)
Final visit (day 42)
Number of physician override advisor recommendations
Time Frame: Final visit (day 42)
Final visit (day 42)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Rabin Medical Center

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Harvard University
DreaMed

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 2, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 1, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 9, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 9, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 10, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 1, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 29, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • RMC018718ctil

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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