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

Type 1 Diabetes Clinical Trial

Official title:

Prevention of Hypoglycaemia Using the Minimed®640G System

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02325193
• Other study ID #: MM640G
• Status: Completed
• Phase: N/A
• First received: December 19, 2014
• Last updated: March 2, 2016
• Start date: March 2015
• Est. completion date: March 2016

Study information

• Verified date: March 2016
• Source: Kinderkrankenhaus auf der Bult
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Observational

Clinical Trial 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.

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)).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: March 2016
• Est. primary completion date: March 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 1 Year to 21 Years

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Hypoglycemia
• Type 1 Diabetes

Intervention

Device:
• Minimed®640G system
Sensor augmented insulin therapy with and without use of Predictive low glucose management (PLGM)

Locations

Country	Name	City	State
Germany	Kinder - und Jugendkrankenhaus AUF DER BULT	Hannover

Sponsors (2)

Lead Sponsor	Collaborator
Kinderkrankenhaus auf der Bult	Medtronic International Trading Sarl

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	average AUC/day in hypoglycaemic range < 70mg/dl (3,9mmo/l)		6 weeks	No
Secondary	Number of PLGM activities		6 weeks	No