The MiniMed™ 780G Glycemic Control and Quality of Life Study for the Treatment of Pediatric and Adult Subjects With Type 1 Diabetes in France.

Medtronic Diabetes306 enrolled

Overview

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.

Local, post-market, non-interventional, prospective, single-arm, multi-center study of patients pediatric and adult. The study is conducted according to the same schedule as the routine follow-up of patients: 1. RUN-IN PHASE: Subject will start a run-in phase in an out of hospital setting, as per standard practice of the site. The objective of the run-in phase is to train the subjects on the MiniMed™ 780G insulin pump, assess subjects' compliance and ability to comprehend the study procedures and tolerance of wearing the sensor and transmitter continuously. It is expected that during the run-in phase the MiniMed™ 780G insulin pump will be set in Manual mode and all the algorithms are switched off, and baseline Continuous Glucose Monitoring (CGM) data will be collected. The expected duration of the run-in phase is approximately 2 weeks. At the end of the run-in phase the MiniMed™ 780G insulin pump will be set in Auto Mode and the date of activation will be collected and identified as a start of the study phase. Data from the MiniMed™ 780G insulin pump will be uploaded in the CareLink™ as per standard practice, before Auto Mode activation. 2. 6 AND 12 MONTHS FOLLOW UP: Follow-up visits will be performed according to the therapy management standard of care at 6 and 12 months after Auto Mode activation in the study. Approximately 300 patients (children and adults) will be enrollment in the study in approximately 32 sites in France.

Study Type

OBSERVATIONAL

Enrollment

306

Conditions

Type 1 Diabetes

Interventions

MiniMed™ 780G SystemDEVICE

Subject enrolled in the study will start using the MiniMed™ 780G pump in Auto Mode after a run-in period of two weeks in Manual Mode (with no SmartGuard™ functions). Study phase in Automode will follow a 6 and 12 months follow- up as per standard of care.

Eligibility

Sex: ALLMin age: 7 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Subject is ≥7 years of age. 2. 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. 3. Subject has a HbA1c value greater than 6.5% and less than 12% at time of enrolment visit. 4. Subject is under Continuous Subcutaneous Insulin Infusion (CSII) therapy (with or without Continuous Glucose Monitoring) ≥ 6 months before enrolment. 5. Subject requires ≥8 units of insulin per day. 6. Subjects and their parent(s)/guardian(s) must be able to speak and be literate in French as verified by the investigator. 7. Subjects and their parent(s)/guardian(s) are willing to participate in the study and sign the Data Release Form (DRF). 8. Subjects who are ≥18 years of age should be able to provide consent. Exclusion Criteria: 1. Subject has MiniMed™ 780G System IFU contraindication(s). 2. Subject uses Predictive Low-Glucose Management (PLGM) System (i.e. MiniMed™ 640G with SmartGuard) in the last 6 months before the enrolment. 3. Subject uses Low Glucose suspend (LGS) feature (i.e. MiniMed™ Paradigm Veo Pump) in the last 6 months before the enrolment. 4. Subject under Multiple-Daily Injections (MDI) treatment in the 6 months before the enrolment. 5. Subject has any unresolved adverse skin condition in the area of sensor placement (e.g., psoriasis, dermatitis herpetiformis, rash, Staphylococcus infection).

Locations (32)

CHU Angers

Angers, France

Outcomes

Primary Outcomes

Time in Range 70-180 mg/dL (TIR)

The change in (%) the time spent within range, defined as the proportion of sensor glucose concentration within the target range of 70-180 mg/dL, between baseline and 6 months.

Time frame: 0-6 months

Secondary Outcomes

Satisfaction Score

To evaluate the change from baseline in satisfaction score based on the Diabetes Treatment Satisfaction Questionnaire change (DTSQc)

Time frame: 0-6 months

Quality of Life Change

To evaluate the change in quality of life based on the Diabetes Quality of life questionnaire (DQoL)

Time frame: 0-6 months

Fear of Hypoglycemic Events Change

To evaluate the change from baseline in the fear of hypoglycemic events based on the Hypoglycemia Fear Survey (HFS)

Time frame: 0-6 months

Treatment Satisfaction Score

To evaluate the treatment satisfaction score based on the Diabetes Treatment Satisfaction Questionnaire status (DTSQs)

Time frame: 0-6 months

Glycemic Parameters Changes

To evaluate the change in glycemic parameters: mean time of sensor glucose values below 70mg/dL

Time frame: 0-6 months

Glycemic Parameters Changes

To evaluate the change in glycemic parameters: mean time of sensor glucose values below 54mg/dL

Time frame: 0-6 months

Glycemic Parameters Changes

Data from ClinicalTrials.gov

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