Assessment of Two Insulin Pump Insulin Delivery Systems in Type 1 Diabetes.

NCT04073576 | Unknown FDA Device

• 1 other identifier: CH-1803-AHCL
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

This is a study of the Minimed 670G 4.0 insulin pump, assessing the efficacy of the Advanced Hybrid Closed Loop (AHCL) algorithm in controlling blood glucose levels in Type 1 Diabetes.

Conditions

Type1diabetes

Outcome Measures

Primary Outcomes (1)

• Performance of the AHCL system

  percentage of sensor glucose values between 3.9 - 10.0 mmol/L

  4 weeks

Secondary Outcomes (1)

• Safety of the AHCL system

  4 weeks

Study Arms (2)

AHCL

EXPERIMENTAL

Advanced Hybrid Closed Loop

Device: AHCL

SAP+PLGM

ACTIVE COMPARATOR

Sensor Augmented Pump with Predictive Low Glucose Monitoring

Device: SAP+PLGM

Interventions

AHCL DEVICE

Closed loop algorithm contained in the MiniMed™ 670G 4.0 pump to be used in the study; includes a modified proportional integrative derivative (PID) model, with insulin feedback, an auto correction bolus feature and additional safety features.

AHCL

SAP+PLGM DEVICE

Sensor Augmented Pump (SAP) Therapy Mode with Predictive Low Glucose Management (PLGM), contained in the the MiniMed™ 670G 4.0 pump to be used in the study.

SAP+PLGM

Eligibility Criteria

• Age: 7 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female aged 7 - 80 years inclusive.
• Type I diabetes as per the American Diabetes Association Classification, diagnosed at least 1 year prior to Study Day 1.
• On insulin pump therapy for at least 6 months prior to study Day 1.
• Minimum daily insulin requirement (Total Daily Dose) of greater than or equal to 8 units.
• Willing and able to adhere to the study protocol.
• Access to the internet and a computer system that meets requirements for uploading the study pump.

You may not qualify if:

• Mean HbA1c more than 10.0% (86 mmol/mol) within 6 months prior to Study Day 1 (minimum of one test).
• Use of a medication indicative of diabetes complications (ACE inhibitors and statins are permitted).
• Use of systemic glucocorticoids within 2 weeks prior to the Baseline visit.
• Current use of SGLT-2 or GLP-1 medications.
• History or current evidence of significant seizure disorder, renal impairment or cardiovascular disease (including uncontrolled hypertension), in the opinion of the Investigator.
• History of severe visual impairment, in the opinion of the Investigator.
• Any clinically significant concomitant disease or condition that could interfere with, or for which the treatment of might interfere with, the conduct of the study, or that would, in the opinion of the investigator, pose an unacceptable risk to the subject in this study.

Sponsors & Collaborators

• Christchurch Clinical Studies Trust Ltd: lead
• Medtronic: collaborator

Study Sites (1)

Christchurch Clinical Studies Trust

Christchurch, Canterbury, 8011, New Zealand

RECRUITING

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 27, 2019
• First Posted: August 29, 2019
• Study Start: May 20, 2019
• Primary Completion: October 11, 2019
• Study Completion: October 11, 2019
• Last Updated: August 29, 2019

Record last verified: 2019-08

Data Sharing

• IPD Sharing: Will not share

Locations

NZ (1)