N/A
Completed N=101
Evaluation of the MiniMed 780 System in Paediatric Subjects
Diabetes type1 · Children, Only
Source: ClinicalTrials.gov NCT05574062 ↗
Enrolled (actual)
101
Serious AEs
2.8%
Results posted
Jun 2025
Primary outcomePrimary: Study Phase Primary Endpoint: Percentage of Time in Range (TIR 70 to 180 mg/dL [3.9-10.0 mmol/L]) - Non-inferiority Test — 68.34; 58.34 percentage of time
Summary
The purpose of this study is to demonstrate the safety and performance of the MiniMed™ 780G system in pediatric subjects (2-6 years old) with type 1 diabetes in a home setting.
The objective of this study is to evaluate the safety and performance of the MiniMed™ 780G system in Auto Mode firstly in comparison to the MiniMed™ 780G system in Manual Mode with Suspend before low activated (currently available standard therapy) and secondly in comparison to the new MiniMed™ 780G BLE 2.0 system with DS5 sensor in Auto Mode among pediatric population (2-6 years old).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Study Phase Primary Endpoint: Percentage of Time in Range (TIR 70 to 180 mg/dL [3.9-10.0 mmol/L]) - Non-inferiority Test |
68.34; 58.34 | — |
| PRIMARY Continuation Phase Primary Endpoint: Mean HbA1c (%) - Non-inferiority Test |
7.30; 7.24 | — |
| SECONDARY Study Phase Secondary Endpoint 1- Mean HbA1c (%) - Non-inferiority Test |
7.00; 7.61 | — |
| SECONDARY Study Phase Secondary Endpoint 2 - Percentage of Time in Range (TIR 70 to 180 mg/dL [3.9-10.0 mmol/L]) - Superiority Test |
68.34; 58.34 | <.0001 sig |
| SECONDARY Study Phase Secondary Endpoint 3 - Mean HbA1c (%) - Superiority Test. |
7.00; 7.61 | <.0001 sig |
| SECONDARY Continuation Phase Secondary Endpoint 1- Mean HbA1c (%) - Superiority Test |
7.30; 7.24 | 0.1097 |
| SECONDARY Continuation Phase Secondary Endpoint 2- Percentage of Time in Range (TIR 70 to 180 mg/dL [3.9-10.0 mmol/L]) - Non-inferiority Test |
69.7; 68.8 | — |
| SECONDARY Continuation Phase Secondary Endpoint 3- Percentage of Time in Range (TIR 70 to 180 mg/dL [3.9-10.0 mmol/L]) - Superiority Test |
69.66; 68.86 | 0.0581 |
Eligibility Criteria
Inclusion Criteria
- Aged 2 - 6 years at time of screening
- Has a clinical diagnosis of type 1 diabetes for ≥ 6 months prior to screening as determined via medical record or source documentation by an individual qualified to make a medical diagnosis
- Is on MDI therapy or CSII with or without CGM prior to screening
- Has a glycosylated hemoglobin (HbA1c) 1 DKA event not related to illness or initial diagnosis in the last 3 months.
- Parent(s)/legal guardian(s) are part of research staff involved with the study.
- Parent(s)/legal guardian(s) are illiterate
Data sourced from ClinicalTrials.gov (NCT05574062). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.