Evaluation of MiniMed Next Generation Extended Wear Sensors and Algorithm in Patients With Type 1 and Type 2 Diabetes
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age2-80
SponsorMedtronic MiniMed, Inc.
About this trial
This study will collect sensor data in subjects with T1D or T2D, 2-80 years of age.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age 2-80 years at time of screening.
Age 2-10 years: Has a clinical diagnosis of T1D or T2D as determined via medical record/ source documentation by an individual qualified to make a medical diagnosis.
Age 11-80 years: Has a clinical diagnosis of T1D or T2D for 6 months or more, as determined via medical record or source documentation by an individual qualified to make a medical diagnosis.
Subject or parent(s)/ guardian(s)/ caregiver(s) is/are literate and able to read the language offered in the study materials.
Disqualifiers
Unable to consent due to a mental or intellectual disability.
Has a history of 1 or more episodes of severe hypoglycemia during the 6 months prior to screening visit.
Has had a hypoglycemic seizure within the past 6 months prior to screening visit.
Has had hypoglycemia resulting in loss of consciousness within the past 6 months prior to enrollment.
Trial design
Design model
Single group
Treatments tested in this trial
Next Generation Extended Wear Sensors
DeviceDisposable Sensor (MMT-5600XNG and MMT-5600X) - labeled as DS5K and referred to as Unity
Treatment groups
1,500 Participants
are divided into 1 treatment groupGroup A: Next Generation Extended Wear SensorsExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Primary Safety Endpoints
Descriptive summary will be used to characterize: * Skin assessment of subject's glucose sensor insertion sites * Adverse events (AE) to include: * Serious Adverse Events (SAE) * Device Related AEs * Procedure Related AEs * Serious Adverse Device Effects (SADE) * Unanticipated Adverse Device Effects (UADE) * Severe hypoglycemia * Diabetic Ketoacidosis (DKA) * Hyperosmolar Hyperglycemic State (HHS)
Time frame
Approximately up to 46 daysSponsors and contacts
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Source ClinicalTrials.gov