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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

OutcomeResultp-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).
View full record on ClinicalTrials.gov →

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.

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