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

NCT02325193 | Completed

• 1 other identifier: MM640G
• Study Type: observational
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Type 1 Diabetes

Outcome Measures

Primary Outcomes (1)

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

  6 weeks

Secondary Outcomes (1)

• Number of PLGM activities

  6 weeks

Interventions

Minimed®640G system DEVICE

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

Eligibility Criteria

• Age: 1 Year - 21 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Probability Sample

Study Population

* patients with type 1 diabetes * CSII since 3 month at least

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Kinderkrankenhaus auf der Bult: lead
• Medtronic International Trading Sarl: collaborator

Study Sites (1)

Kinder - und Jugendkrankenhaus AUF DER BULT

Hanover, 30173, Germany

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Thomas Danne, MD

  Kinder - und Jugendkrankenhaus AUF DER BULT

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr. med.

Study Record Dates

• First Submitted: December 19, 2014
• First Posted: December 24, 2014
• Study Start: March 1, 2015
• Primary Completion: March 1, 2016
• Study Completion: March 1, 2016
• Last Updated: March 3, 2016

Record last verified: 2016-03

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)