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Completed

NCT Number: NCT02325193

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

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.

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Key information

Conditions

Type 1 Diabetes Autoimmune Diseases Diabetes Mellitus Diabetes Mellitus, Type 1 Endocrine System Diseases Glucose Metabolism Disorders Immune System Diseases Metabolic Diseases Nutritional and Metabolic Diseases

Age range

1 year–21 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Kinder - und Jugendkrankenhaus AUF DER BULT

Hanover, 30173, Germany

About this study

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)).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Minimed®640G system

Device

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

Primary outcomes

  1. average AUC/day in hypoglycaemic range < 70mg/dl (3,9mmo/l)

    Time frame: 6 weeks

Secondary outcomes

  1. Number of PLGM activities

    Time frame: 6 weeks

Sponsors and collaborators

Lead sponsor

Kinderkrankenhaus auf der Bult

Other

Collaborators

  • Medtronic International Trading Sarl

Registry information

Official study title

Prevention of Hypoglycaemia Using the Minimed®640G System

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Dec 24, 2014
Registry last updated
Mar 3, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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