NCT02325193

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

Prevention of Hypoglycaemia Using the Minimed®640G System

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 24 (actual)
• Sponsor: Kinderkrankenhaus auf der Bult · Academic / Other
• Sex: All
• Age: 1 Year – 21 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DEVICE	Minimed®640G system	Sensor augmented insulin therapy with and without use of Predictive low glucose management (PLGM)

Timeline

• Start date: 2015-03-01
• Primary completion: 2016-03-01
• Completion: 2016-03-01
• First posted: 2014-12-24
• Last updated: 2016-03-03

Locations

1 site across 1 country: Germany