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

Sponsor

Kinderkrankenhaus auf der Bult (Other)

Overall Status

Completed

CT.gov ID

NCT02325193

Collaborator

Medtronic International Trading Sarl (Industry)

Enrollment

Location

Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Type 1 Diabetes	Device: Minimed®640G system

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 Design

Study Type:

Observational

Actual Enrollment :

24 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Prevention of Hypoglycaemia Using the Minimed®640G System

Study Start Date :

Mar 1, 2015

Actual Primary Completion Date :

Mar 1, 2016

Actual Study Completion Date :

Mar 1, 2016

Outcome Measures

Primary Outcome Measures

average AUC/day in hypoglycaemic range < 70mg/dl (3,9mmo/l) [6 weeks]

Secondary Outcome Measures

Number of PLGM activities [6 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:

1 Year to 21 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Kinder - und Jugendkrankenhaus AUF DER BULT	Hannover		Germany	30173

Sponsors and Collaborators

Kinderkrankenhaus auf der Bult
Medtronic International Trading Sarl

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Thomas Danne, Prof. Dr. med., Kinderkrankenhaus auf der Bult

ClinicalTrials.gov Identifier:

NCT02325193

Other Study ID Numbers:

MM640G

First Posted:

Dec 24, 2014

Last Update Posted:

Mar 3, 2016

Last Verified:

Mar 1, 2016

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Additional relevant MeSH terms:

Hypoglycemia

Study Results

No Results Posted as of Mar 3, 2016