N/A
Completed N=290
The MiniMed™ 780G Glycemic Control and Quality of Life Study for the Treatment of Pediatric and Adult Subjects With Type 1 Diabetes in France.
Source: ClinicalTrials.gov NCT04308291 ↗Enrolled (actual)
290
Serious AEs
—
Results posted
Jul 2024
Primary outcomePrimary: Time in Range 70-180 mg/dL (TIR) — 11.81 % of time — p=<0.0001
Summary
The purpose of the study is to evaluate the efficacy in glycemic control and the impact on the quality of life of patients using the MiniMed™ 780G System for the treatment of Type 1 diabetes, in real life settings in France.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Time in Range 70-180 mg/dL (TIR) |
11.81 | <0.0001 sig |
| SECONDARY Satisfaction Score |
— | — |
| SECONDARY Quality of Life Change |
— | — |
| SECONDARY Fear of Hypoglycemic Events Change |
— | — |
| SECONDARY Treatment Satisfaction Score |
— | — |
| SECONDARY Glycemic Parameters Changes |
— | — |
| SECONDARY HbA1c |
-0.42 | — |
| SECONDARY Time in Range of 70-180 mg/dL (TIR) |
11.09 | — |
Eligibility Criteria
Inclusion Criteria
- Subject is ≥7 years of age.
- Subject has a clinical diagnosis of type 1 diabetes for more than 1 year as determined via medical records or source documentation by an individual qualified to make a medical diagnosis.
- Subject has a HbA1c value greater than 6.5% and less than 12% at time of enrolment visit.
- Subject is under Continuous Subcutaneous Insulin Infusion (CSII) therapy (with or without Continuous Glucose Monitoring) ≥ 6 months before enrolment.
- Subject requires ≥8 units of insulin per day.
- Subjects and their parent(s)/guardian(s) must be able to speak and be literate in French as verified by the investigator.
- Subjects and their parent(s)/guardian(s) are willing to participate in the study and sign the Data Release Form (DRF).
- Subjects who are ≥18 years of age should be able to provide consent.
Exclusion Criteria
- Subject has MiniMed™ 780G System IFU contraindication(s).
- Subject uses Predictive Low-Glucose Management (PLGM) System (i.e. MiniMed™ 640G with SmartGuard) in the last 6 months before the enrolment.
- Subject uses Low Glucose suspend (LGS) feature (i.e. MiniMed™ Paradigm Veo Pump) in the last 6 months before the enrolment.
- Subject under Multiple-Daily Injections (MDI) treatment in the 6 months before the enrolment.
- Subject has any unresolved adverse skin condition in the area of sensor placement (e.g., psoriasis, dermatitis herpetiformis, rash, Staphylococcus infection).
Data sourced from ClinicalTrials.gov (NCT04308291). 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.