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

March 2, 2016 updated by: Thomas Danne, Kinderkrankenhaus auf der Bult

Prevention of Hypoglycaemia Using the Minimed®640G System

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

In the first phase of two weeks, the sensor-augmented pump therapy (SaP) is carried out without these interruption PLGM algorithm. In a second phase for 6 weeks, the PLGM function is set. Both phases are compared in terms of the rate of hypoglycemia, the time spent and the area under the curve (AUC) glucose range (values <70 mg / dl (3.9 mmol / l)).

Study Type

Observational

Enrollment (Actual)

24

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Hannover, Germany, 30173
        • Kinder - und Jugendkrankenhaus AUF DER BULT

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year to 21 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

  • patients with type 1 diabetes
  • CSII since 3 month at least

Description

Inclusion Criteria:

  • type 1 diabetes, diagnosed since 12 month at least
  • continuous subcutaneous insulin infusion (CSII) since 3 month at least
  • stable outcome since 3 month at least
  • willingness of patients/ parents to wear a glucose sensor for 2 month
  • willingness of patients/ parents to use the Minimed®640G system
  • willingness of patients/ parents to complete a diary
  • willingness of patients/ parents to comply the requirements of the study protocol

Exclusion Criteria:

  • longer absence of the patients (not able to attend the study visits)
  • subject with allergy of sensor or specific sensor components
  • communication problems
  • significant history of eating disorder, anorexia, bulimia
  • pregnancy
  • significant history of drug abuse or/ and alcoholism
  • patient do not want to attend the trial
  • missing informed consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
average AUC/day in hypoglycaemic range < 70mg/dl (3,9mmo/l)
Time Frame: 6 weeks
6 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Number of PLGM activities
Time Frame: 6 weeks
6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kinderkrankenhaus auf der Bult

Collaborators

Medtronic International Trading Sarl

Investigators

  • Principal Investigator: Thomas Danne, MD, Kinder - und Jugendkrankenhaus AUF DER BULT

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2015

Primary Completion (Actual)

March 1, 2016

Study Completion (Actual)

March 1, 2016

Study Registration Dates

First Submitted

December 19, 2014

First Submitted That Met QC Criteria

December 19, 2014

First Posted (Estimate)

December 24, 2014

Study Record Updates

Last Update Posted (Estimate)

March 3, 2016

Last Update Submitted That Met QC Criteria

March 2, 2016

Last Verified

March 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MM640G

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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