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NCT Number: NCT06600776

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

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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Key information

Conditions

Type 1 Diabetes (T1D) Autoimmune Diseases Behavior Diabetes Mellitus Diabetes Mellitus, Type 1 Endocrine System Diseases Glucose Metabolism Disorders Health Behavior Immune System Diseases Metabolic Diseases Nutritional and Metabolic Diseases Patient Preference Patient Satisfaction Treatment Adherence and Compliance

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Ultra Rapid Lispro (URLi)

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.

Other names: Lyumjev

Insulin pump with continuous glucose monitoring (CGM)

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

Other names: MiniMed 780G Hybrid Closed-Loop System

Primary outcomes

  1. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Roy Eldor, MD; PhD

CONTACT

[email protected]

0527360680 ext. +972

Sponsors and collaborators

Lead sponsor

Tel-Aviv Sourasky Medical Center

Other Gov

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Sep 19, 2024
Registry last updated
Sep 24, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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