Mealtime or Post-meal Dosing of URLi in Medtronic 780G Hybrid Closed Loop System

September 22, 2024 updated by: Tel-Aviv Sourasky Medical Center

A Pilot Study Comparing the Efficacy of Dosing Ultra Rapid Insulin Lispro in a Medtronic 780G Hybrid Closed Loop System At Mealtime or Postmeal

This is a pilot study to compare premeal to postmeal dosing of ultra rapid lispro insulin (URLi) used in a MiniMed 780G system hybrid closed loop system. Subjects with type 1 diabetes mellitus (T1DM) already using a 780G hybrid closed loop system with URLi will be included. After signing a remote digital informed consent, a baseline record of the MiniMed 780G system will be downloaded from the Medtronic digital platform (Carelink system [1]) and subjects will be asked to fill an online questionnaire regarding their time of insulin dosing preferences and a 3-day online food diary [2]. During the intervention period subjects will be asked to provide a bolus dose of insulin only at the end of meals for up to 4 weeks. During the last week of the intervention period, subjects will be asked to fill out a 3-day online food diary [2]. At the end of the intervention period- a Carelink report [1] will be collected remotely and subjects will be asked to fill again the online questionnaire regarding their time of dosing preferences.

  1. Primary Objective: To assess the efficacy of premeal dosing to post-meal dosing on parameters of glycemic control as obtained from continuous glucose monitoring.
  2. Secondary Objective: To assess patient dosing preferences and the effect of premeal dosing vs. post-meal dosing on patient reported outcomes

Ref:

  1. carelink.medtronic.eu
  2. NutRatio.com.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

50

Phase

  • Phase 4

Contacts and Locations

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

Study Contact

Study Locations

  • Israel
      • Tel-Aviv, Israel
        • Tel-Aviv Medical Center
        • Contact:

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

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

Participants must be 18 years of age or older (inclusive).

Diagnosed with Type 1 Diabetes Mellitus (T1DM).

Already using the MiniMed 780G hybrid closed-loop system with Ultra Rapid Lispro Insulin (URLi) for at least 2 months prior to study enrollment.

Able and willing to provide informed consent electronically.

Willing and able to comply with the scheduled visits and other study procedures, including remote monitoring and completing questionnaires.

Exclusion Criteria:

Participants with a medical history of untreated active proliferative retinopathy.

Note: Subjects with non-proliferative retinopathy may be included. Subjects with treated proliferative retinopathy may be included based on the investigator's clinical judgment.

Severe acute or chronic medical or psychiatric conditions or laboratory abnormalities that may increase the risk associated with study participation or interfere with the interpretation of study results, as judged by the investigator.

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
Intervention / Treatment
Experimental: Mealtime and Postmeal Dosing of Ultra Rapid Lispro Insulin (URLi)
This arm consists of participants with Type 1 Diabetes Mellitus (T1DM) who are using the Medtronic 780G hybrid closed-loop system with Ultra Rapid Lispro Insulin (URLi). Participants will undergo two intervention phases: in one phase, URLi will be administered at mealtime (premeal dosing), and in the other phase, URLi will be administered immediately after meals (postmeal dosing). The dosage form is subcutaneous insulin infusion, and the insulin dose is based on individual carbohydrate counting. Each intervention phase will last for up to 4 weeks, with glycemic control and patient preferences assessed at the end of each phase.
Drug: Ultra Rapid Lispro (URLi)

Dosage Form:

Subcutaneous insulin infusion

Dosage:

Based on individual carbohydrate counting, adjusted using the MiniMed 780G hybrid closed-loop system.

Frequency:

Administered at mealtime (premeal) during one phase and immediately after meals (postmeal) during the other phase.

Duration:

Each intervention phase lasts up to 4 weeks.

Arm or Group/Intervention Cross-Reference:

Both interventions (mealtime and postmeal dosing) are applied to the single arm of the study.

Other Names:
  • Lyumjev
Device: Insulin pump with continuous glucose monitoring (CGM)

The insulin pump with continuous glucose monitoring (CGM) system is used by patients with Type 1 Diabetes Mellitus (T1DM) as part of their regular treatment regimen. This system combines an insulin pump with real-time glucose monitoring, adjusting basal insulin delivery every 5 minutes based on continuous glucose data. In this study, participants are already using the system before the trial begins. The research does not examine the effect of the CGM itself but rather focuses on the timing of insulin bolus delivery (mealtime vs. postmeal) using their existing treatment system.

Frequency:

The system delivers basal insulin continuously and requires the patient to manually deliver bolus doses at mealtime (premeal) or postmeal, depending on the study phase.

Duration:

The device is used continuously throughout the entire study period, with each intervention phase (premeal vs. postmeal dosing) lasting up to 4 weeks.

Arm or Group/Intervention Cross-Reference:

This device will be us

Other Names:
  • MiniMed 780G Hybrid Closed-Loop System

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Time in Glucose Range (70-180 mg/dL)
Time Frame: Baseline to 4 weeks post-intervention
The primary outcome measure is the percentage of time that blood glucose levels are within the target range of 70-180 mg/dL (Time in Range, TIR) as measured by continuous glucose monitoring (CGM). This will be compared between the mealtime dosing and postmeal dosing phases of Ultra Rapid Lispro Insulin (URLi) in patients using the MiniMed 780G hybrid closed-loop system. The outcome will be assessed from the data collected via the CareLink system throughout the intervention period.
Baseline to 4 weeks post-intervention

Collaborators and Investigators

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

Sponsor

Tel-Aviv Sourasky Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 (Estimated)

October 6, 2024

Primary Completion (Estimated)

September 21, 2025

Study Completion (Estimated)

October 21, 2025

Study Registration Dates

First Submitted

September 16, 2024

First Submitted That Met QC Criteria

September 16, 2024

First Posted (Actual)

September 19, 2024

Study Record Updates

Last Update Posted (Actual)

September 24, 2024

Last Update Submitted That Met QC Criteria

September 22, 2024

Last Verified

September 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TLV-0332-24

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

Yes

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

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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