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

Официальное название

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

Обзор

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.

Вмешательства

• Препарат 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.
• Устройство 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 in

Первичные конечные точки

• Percentage of Time in Glucose Range (70-180 mg/dL) [Срок оценки: Baseline to 4 weeks post-intervention]

Критерии участия

Критерии включения

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.

Критерии исключения

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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Израиль · 1 центр

• Tel-Aviv Medical Center — Tel Aviv

Публикации

• Petrovski G, Campbell J, Pasha M, Day E, Hussain K, Khalifa A, van den Heuvel T. Simplified Meal Announcement Versus Precise Carbohydrate Counting in Adolescents With Type 1 Diabetes Using the MiniMed 780G Advanced Hybrid Closed Loop System: A Randomized Controlled Trial Comparing Glucose Control. Diabetes Care. 2023 Mar 1;46(3):544-550. doi: 10.2337/dc22-1692. PMID 36598841
• Petrovski G, Campbell J, Pasha M, Hussain K, Khalifa A, Umer F, Almajaly D, Hamdar M, Heuvel TVD, Edd SN. Twelve-Month Follow-up from a Randomized Controlled Trial of Simplified Meal Announcement Versus Precise Carbohydrate Counting in Adolescents with Type 1 Diabetes Using the MiniMed 780G Advanced Hybrid Closed-Loop System. Diabetes Technol Ther. 2024 Mar;26(S3):76-83. doi: 10.1089/dia.2023.0429 PMID 38377327
• Warren M, Bode B, Cho JI, Liu R, Tobian J, Hardy T, Chigutsa F, Phillip M, Horowitz B, Ignaut D. Improved postprandial glucose control with ultra rapid lispro versus lispro with continuous subcutaneous insulin infusion in type 1 diabetes: PRONTO-Pump-2. Diabetes Obes Metab. 2021 Jul;23(7):1552-1561. doi: 10.1111/dom.14368. Epub 2021 Mar 23. PMID 33687783
• Datye KA, Boyle CT, Simmons J, Moore DJ, Jaser SS, Sheanon N, Kittelsrud JM, Woerner SE, Miller KM; T1D Exchange. Timing of Meal Insulin and Its Relation to Adherence to Therapy in Type 1 Diabetes. J Diabetes Sci Technol. 2018 Mar;12(2):349-355. doi: 10.1177/1932296817728525. Epub 2017 Sep 12. PMID 28895431
• Arrieta A, Battelino T, Scaramuzza AE, Da Silva J, Castaneda J, Cordero TL, Shin J, Cohen O. Comparison of MiniMed 780G system performance in users aged younger and older than 15 years: Evidence from 12 870 real-world users. Diabetes Obes Metab. 2022 Jul;24(7):1370-1379. doi: 10.1111/dom.14714. Epub 2022 May 12. PMID 35403792
• Bergenstal RM, Beck RW, Close KL, Grunberger G, Sacks DB, Kowalski A, Brown AS, Heinemann L, Aleppo G, Ryan DB, Riddlesworth TD, Cefalu WT. Glucose Management Indicator (GMI): A New Term for Estimating A1C From Continuous Glucose Monitoring. Diabetes Care. 2018 Nov;41(11):2275-2280. doi: 10.2337/dc18-1581. Epub 2018 Sep 17. PMID 30224348
• Choudhary P, Kolassa R, Keuthage W, Kroeger J, Thivolet C, Evans M, Re R, de Portu S, Vorrink L, Shin J, Habteab A, Castaneda J, da Silva J, Cohen O; ADAPT study Group. Advanced hybrid closed loop therapy versus conventional treatment in adults with type 1 diabetes (ADAPT): a randomised controlled study. Lancet Diabetes Endocrinol. 2022 Oct;10(10):720-731. doi: 10.1016/S2213-8587(22)00212-1. Epub PMID 36058207

Идентификаторы

NCT: NCT06600776 · TLV-0332-24

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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