Health TrialsbyHealthPanel

GATEWAY: Safety Evaluation of the MiniMed™ NMX8-AID System in Children and Adults Living With Diabetes

ConditionsType 1 Diabetes MellitusType 2 Diabetes Mellitus
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age7-85
SponsorMedtronic MiniMed, Inc.

About this trial

The purpose of this study is to check that a new insulin pump, called NMX8, is safe when used with a continuous glucose monitoring sensor called Disposable Sensor 5/Simplera Sync in people with diabetes. The study will include people with Type 1 diabetes who are 7-85 years old and people with Type 2 diabetes who are 18-85 years old. Participants will use their current therapy while also wearing the DS5/Simplera sensor for up to 40 days. During this time, they will complete a meal and exercise log. Participants will then be placed into one of three groups by chance and given the NMX8 pump to use for about 90 days. During this time, participants will bolus, not bolus, or bolus at will for meals and continue to complete a meal and exercise log depending on the group they are in. Once their part in the study is over, if participants like the pump and want to keep using it, they may be able to join a Continued Access Period to keep using the NMX8 pump.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

T1D: Age 7-85 years

T2D: Age 18-85 years

T1D (Age 7-85 years): Diagnosis of T1D for at least 6 months, as determined via medical record or source documentation by an individual qualified to make a medical diagnosis.

T2D (Age 18-85 years): Diagnosis of insulin-requiring T2D for 1 year or more, as determined via medical record or source documentation by an individual qualified to make a medical diagnosis

Disqualifiers

Unable to consent due to a mental or intellectual disability.

Medical assistance (i.e., Paramedics, Emergency Room [ER] or Hospitalization)

Coma or

Seizures

Trial design

Design model

Parallel

Treatments tested in this trial

  • MiniMed™ NMX8-AID System with DS5™/Simplera Sync™

    Device

    Patients will be provided with the NMX8 system with DS5/Simplera Sync CGM.

Treatment groups

400 Participants
are divided into 3 treatment groups
Group A: Arm 1 - No meal bolus administrationExperimental treatment 1 intervention
Group B: Arm 2 - Meal bolus administration at all mealsExperimental treatment 1 intervention
Group C: Arm 3 - Meal bolus administration at willExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Study Arm 1: Percent of Time in Range (TIR 70-180 mg/dL)

Percent of time in range (TIR 70-180 mg/dL) among subjects randomized to Study Arm 1. Descriptive only.

Time frame
Throughout the study period, approximately 90 days.
2

Study Arm 1: Percent of Time in Hypoglycemia (< 70 mg/dL)

Percent of time in hypoglycemia (\< 70 mg/dL) among subjects randomized to Study Arm 1. Descriptive only.

Time frame
Throughout the study period, approximately 90 days.
3

Study Arm 2: Percent of Time in Range (TIR 70-180 mg/dL)

Percent of time in range (TIR 70-180 mg/dL) among subjects randomized to Study Arm 2. Descriptive only.

Time frame
Throughout the study period, approximately 90 days.
4

Study Arm 2: Percent of Time in Hypoglycemia (< 70 mg/dL)

Percent of time in hypoglycemia (\< 70 mg/dL) among subjects randomized to Study Arm 2. Descriptive only.

Time frame
Throughout the study period, approximately 90 days.

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Medtronic MiniMed, Inc.

Lead sponsor

Source ClinicalTrials.gov
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