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"MiniMed 640G System" User Evaluation With the Question of Reducing the Rate of Hypoglycemia

NCT02325193 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 24

Last updated 2016-03-03

No results posted yet for this study

Summary

The Minimed®640G system (MM640G) consists of a combination of insulin and glucose sensor for continuous glucose monitoring (CGM). Here, the glucose sensor transmits not only the continuous glucose data on the display of insulin pump but, in the case of hypoglycemia also interrupt their insulin delivery of pump. In the currently available system Paradigm®VEO, the interruption takes place at a settled threshold level. In difference in the new system MM640G the shutdown algorithm can already be proactive and help avoid hypoglycemia completely. The so called PLGM algorithm (predictive low glucose management) should be tested in the user evaluation. The main objective is to answer the question of reducing the rate of hypoglycemia by application of the new PLGM algorithm.

Included are a total of 24 patients, aged 1-21 years, in three pediatric diabetes centers.

Conditions

Interventions

DEVICE

Minimed®640G system

Sensor augmented insulin therapy with and without use of Predictive low glucose management (PLGM)

Sponsors & Collaborators

  • Medtronic International Trading Sarl

    collaborator INDUSTRY

  • Kinderkrankenhaus auf der Bult

    lead OTHER

Principal Investigators

  • Thomas Danne, MD · Kinder - und Jugendkrankenhaus AUF DER BULT

Eligibility

Min Age
1 Year
Max Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-03-31
Primary Completion
2016-03-31
Completion
2016-03-31

Countries

  • Germany

Study Locations

More Related Trials

Entities

Diseases

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 NCT02325193 on ClinicalTrials.gov