CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 10 enrolled
Drug / intervention
MiniMed 670G systemdevice
Likely dose
MiniMed 670G systemfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03215914
NCT03215914N/ACompleted
CompareCT.gov

Effect of Hybrid Closed-Loop Insulin Delivery on Glucose Counterregulation in Long Standing Type 1 Diabetes: A Proof of Concept, Mechanistic, Single-Arm Clinical Trial

University of Pennsylvania·interventional·Posted Jul 12, 2017·Updated Oct 24, 2024

In Brief

A clinical study evaluating MiniMed 670G system for Type1diabetes and 4 related conditions. Completed, enrolled 10 participants across 3 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsType1diabetes, Hypoglycemia Unawareness, Nocturnal Hypoglycemia, Hypoglycemia Night, Hypoglycemia
CountriesUnited States
CollaboratorsNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Timeline

N/ACompletedFinished
201820192020202120222023202420252026
First PostedJul 12, 2017
Enrollment StartAug 1, 2017
Primary CompletionMay 31, 2022
Study CompletionOct 1, 2024
TodayJul 2, 2026
Enrollment to primary: 4.8 yearsPosted 9.0 years ago

Interventions

MiniMed 670G systemdevice

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.