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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

PHASE4

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-10-06

Study Completion Date

2025-10-21

Brief Summary

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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.

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Detailed Description

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Conditions

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Type 1 Diabetes (T1D)

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Single Intervention Group: The study involves a single group of participants, all of whom are individuals with Type 1 Diabetes Mellitus (T1DM) using the Medtronic 780G hybrid closed-loop system with Ultra Rapid Lispro Insulin (URLi).

Comparison Within Subjects: Participants will be asked to use the insulin dosing at mealtime during one period and post-meal during another. The study aims to compare the effects of premeal vs. post-meal dosing on glycemic control within the same group of individuals rather than comparing two different groups of participants.

So, participants serve as their own control(in this case, mealtime vs. post-meal dosing).

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Both the researchers and the participants are aware of the intervention being administered (premeal vs. post-meal dosing of Ultra Rapid Lispro Insulin). There is no blinding in the study, as participants will know when they are administering the insulin (whether at mealtime or post-meal), and the researchers will also have access to this information during data collection and analysis.

Study Groups

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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.

Group Type EXPERIMENTAL

Ultra Rapid Lispro (URLi)

Intervention Type DRUG

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.

Insulin pump with continuous glucose monitoring (CGM)

Intervention Type DEVICE

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

Interventions

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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.

Intervention Type DRUG

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

Intervention Type DEVICE

Other Intervention Names

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Lyumjev MiniMed 780G Hybrid Closed-Loop System

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No