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Hybrid Closed Loop Insulin Delivery System in Hypoglycemia

NCT03215914 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2024-10-24

Study results available
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Summary

Can a type 1 diabetic adult avoid low glucoses and regain hypoglycemia awareness using a hybrid closed loop insulin delivery system? Involvement is 22 months (13 visits) and includes a 4-week Screening Phase and an 18-month Intervention Phase. Participants will undergo 3 Hyperinsulinemic Clamps done at: Baseline (before starting the device and after completing the screening), 6 months (after using the device 6 months), and after using the device for 18 months. This metabolic testing will allow us to measure improvement in hypoglycemia awareness.

Conditions

  • Type1diabetes
  • Hypoglycemia Unawareness
  • Nocturnal Hypoglycemia
  • Hypoglycemia Night
  • Hypoglycemia

Interventions

DEVICE

MiniMed 670G system

Eligible subjects with type 1 diabetes will initiate hybrid closed-loop insulin delivery based on interstitial glucose monitoring via the MiniMed 670G system according to Medtronic's labeling. This system combines subject-delivered pre-meal boluses with automatic interprandial insulin delivery that includes automated functions for both predictive and threshold suspension of insulin delivery intended to minimize exposure to glucose levels \< 70 mg/dl.

Sponsors & Collaborators

Principal Investigators

  • Michael R Rickels, MD · University of Pennsylvania

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
25 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-08-01
Primary Completion
2022-05-31
Completion
2024-10-01
FDA Device
Yes

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03215914 on ClinicalTrials.gov