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

NCT ID: NCT02325193

Last Updated: 2016-03-03

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 24 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2015-03-31
• Study Completion Date: 2016-03-31

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.

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)).

Conditions

Type 1 Diabetes

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

Minimed®640G system

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

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 1 Year
• Maximum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medtronic International Trading Sarl

INDUSTRY

Sponsor Role: collaborator

Kinderkrankenhaus auf der Bult

OTHER

Sponsor Role: lead

Responsible Party

Thomas Danne

Prof. Dr. med.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Thomas Danne, MD

Role: PRINCIPAL_INVESTIGATOR

Kinder - und Jugendkrankenhaus AUF DER BULT

Locations

Kinder - und Jugendkrankenhaus AUF DER BULT

Hanover, , Germany

Countries

Germany

Other Identifiers

MM640G

Identifier Type: -

Identifier Source: org_study_id