Type 1 Diabetes (T1D)
Conditions
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)
Brief 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. 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.
Interventions
DRUGUltra 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.
DEVICEInsulin 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
Sponsors
Tel-Aviv Sourasky Medical Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Masking description
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.
Intervention 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).
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Time in Glucose Range (70-180 mg/dL) | 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. |
Countries
Israel
Contacts
Primary ContactRoy Eldor, MD; PhD
Outcome results
None listed