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Type 1 Diabetes (T1D)Phase 4NCT06600776

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

A Phase 4 study testing Ultra Rapid Lispro (URLi) and Insulin pump with continuous glucose monitoring (CGM) in people with Type 1 Diabetes (T1D), run by Tel-Aviv Sourasky Medical Center at 1 site in Israel.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Type 1 Diabetes (T1D)
What is being tested?
Ultra Rapid Lispro (URLi) and Insulin pump with continuous glucose monitoring (CGM)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
50 participants
Where
1 siteIsrael
Study dates
6 Oct 2024to 21 Oct 2025
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Roy Eldor, MD; PhD contact

0527360680 ext. +972

roye@tlvmc.gov.il

Israel1 site

  • Tel-Aviv Medical Center

    Tel Aviv

    Roy Eldor, MD; Phd, 0527360680 ext. +972, roye@tlvmc.gov.il

Other trials in Israel

About this study

Official 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

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
Read more

Ref:

  1. carelink.medtronic.eu
  2. NutRatio.com.
Being tested
Ultra Rapid Lispro (URLi), Insulin pump with continuous glucose monitoring (CGM)
Keywords
Automated Insulin Delivery, Continuous Glucose Monitoring (CGM), Glycemic Control, Hybrid Closed Loop System, Insulin Bolus, Lyumjev, Mealtime Dosing, Medtronic 780G, Patient Preferences, Postmeal Dosing, Postprandial Glycemia, Time in Range (TIR), Type 1 Diabetes Mellitus (T1DM), Ultra Rapid Lispro Insulin (URLi)
Medical subject headings
Diabetes Mellitus, Type 1, Patient Preference

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Ultra Rapid Lispro (URLi)Drug

    Also called Lyumjev

    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)Device

    Also called MiniMed 780G Hybrid Closed-Loop System

    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

Study groups in NCT06600776
Study groupRoleWhat they receive
Mealtime and Postmeal Dosing of Ultra Rapid Lispro Insulin (URLi)ExperimentalThis 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.
Receives: Drug: Ultra Rapid Lispro (URLi); Device: Insulin pump with continuous glucose monitoring (CGM)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Baseline to 4 weeks post-intervention

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Sep 2024
  2. Study start6 Oct 2024 (estimated)
  3. Primary completion21 Sep 2025 (estimated)
  4. Study completion21 Oct 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
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).
Masking
None (open label)
Enrolment
50 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06600776
Sponsor's protocol ID
TLV-0332-24
Status last verified
Sep 2024
First submitted
16 Sep 2024
Last updated
24 Sep 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
Yes
Individual data sharing
No

Publications

  • 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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 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 2022 Sep 1.

    PubMed 36058207

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Ultra Rapid Lispro (URLi) and Insulin pump with continuous glucose monitoring (CGM) in people with Type 1 Diabetes (T1D), run by Tel-Aviv Sourasky Medical Center at 1 site in Israel.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 24 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Roy Eldor, MD; PhD (0527360680 ext. +972, roye@tlvmc.gov.il), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Time in Glucose Range (70-180 mg/dL) (time frame: Baseline to 4 weeks post-intervention). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06600776, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Sep 2024.

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