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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mealtime and Postmeal Dosing of Ultra Rapid Lispro Insulin (URLi) | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Time in Glucose Range (70-180 mg/dL) | 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 |
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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.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Roy Eldor, MD; PhD | Contact | 0527360680 | +972 | roye@tlvmc.gov.il |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tel-Aviv Medical Center | Tel Aviv | Israel |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36598841 | Result | 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. | |
| 38377327 |
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| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| D057240 | Patient Preference |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D000095583 | Continuous Glucose Monitoring |
| ID | Term |
|---|---|
| D001774 | Blood Chemical Analysis |
| D019963 | Clinical Chemistry Tests |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
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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).
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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.
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| 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 |
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| 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. |
| 33687783 | Result | 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. |
| 28895431 | Result | 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. |
| 35403792 | Result | 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. |
| 30224348 | Result | 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. |
| 36058207 | Result | 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 2022 Sep 1. |
| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D017060 | Patient Satisfaction |
| D000074822 | Treatment Adherence and Compliance |
| D015438 | Health Behavior |
| D001519 | Behavior |
| D003933 | Diagnosis |
| D003940 | Diagnostic Techniques, Endocrine |
| D008991 | Monitoring, Physiologic |
| D008919 | Investigative Techniques |