Health TrialsbyHealthPanel

To Study the Efficacy and Safety of Medtronic 780G Insulin Pump in People With Gastroparesis and Type 1 Diabetes.

ConditionsType 1 DiabetesGastroparesis Due to Diabetes Mellitus Type I
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorViral N. Shah

About this trial

The goal of this clinical trial is to evaluate the efficacy and safety of Medtronic 780G automated insulin delivery system in adult persons with type 1 diabetes and gastroparesis.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age ≥18 years

Diagnosis of T1D for at least 12 months with stable insulin regimen for at least 2 months

HbA1c ≥8.0%

Diagnosis of gastroparesis per National Institute of Health (NIH) definition

Disqualifiers

Age <18 years

Current use of inhaled insulin (Afrezza)

Patients with T1D using any glucose lowering medications other than insulin at the time of screening

Pregnancy, breast feeding, or wanting to become pregnant

Trial design

Design model

Parallel

Treatments tested in this trial

  • Medtronic 780G AID

    Device

    Participants in Medtronic AID treatment group will use it for three months

Treatment groups

34 Participants
are divided into 2 treatment groups
Group A: Medtronic 780G groupExperimental treatment 1 intervention
Group B: Usual careNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Time in Range (70-180 mg/dL)

Percentage of time that sensor glucose values are within the target range of 70-180 mg/dL, as measured by continuous glucose monitoring (CGM).

Time frame
Baseline to 3 months

Secondary outcomes

1

HbA1c

Change in glycated hemoglobin (HbA1c) measured using standard laboratory methods.

Time frame
Baseline to 3 months
2

Mean Sensor Glucose

Mean sensor glucose value derived from CGM data.

Time frame
Baseline to 3 months
3

Time in Tight Target Range (70-140 mg/dL)

Percentage of time that sensor glucose values are between 70 and 140 mg/dL (TTIR), measured by CGM.

Time frame
Baseline to 3 months
4

Time Above Range

Percentage of time that sensor glucose values are \>180 mg/dL and \>250 mg/dL, measured by CGM.

Time frame
Baseline to 3 months

Other outcomes

1

Severe Hypoglycemia

Number of severe hypoglycemic events requiring assistance from another person.

Time frame
3 months
2

Diabetic Ketoacidosis

Number of diabetic ketoacidosis events defined by standard clinical criteria.

Time frame
3 months

Sponsors and contacts

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

Viral N. Shah

Lead sponsor

Indiana University

Sponsor institution

Medtronic

Collaborator

Source ClinicalTrials.gov
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