Comparison of Two Management Systems in Patients With Type 1 Diabetes (Pediatric SmartHome)

NCT03815487 | Completed

• 1 other identifier: PSH-KKB1/ NERP15-028
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

Closed loop technology has been shown to reduce both hypoglycemia and hyperglycemia, as well as reduce glycemic variability. Sensor augmented pump (SAP) therapy means the addition of alerts according to high or low glucose values as well as trend arrows showing actual glucose trends to pump therapy. This Hybrid closed loop (HCL) system provides several additional effects compared to SAP therapy: according to actual and predicted sensor glucose values, the insulin therapy can be adopted automatically by pump: in case of high values (or predicted) more insulin will be administered, in case of low values (or predicted) the insulin infusion will be decreased a suspended and resumed again. So the HCL provides a lot more automatic functions to keep glucose in target compared to SAP. The aim of the current trial is to compare the SAP-therapy with the hybrid closed loop glucose management in patients with type 1 diabetes at home.

Conditions

Patient Care; Drug Therapy

Keywords

pediatrics; type 1 diabetes; insulin pump; closed loop

Outcome Measures

Primary Outcomes (1)

• Reduction of Sensor Glucose

  Time in Range (% of Sensor Glucose 70-180 mg/dL) (SAP period vs Hybrid Closed loop)

  6 month

Study Arms (2)

Therapy with Hybrid Closed Loop (HCL)

EXPERIMENTAL

The Intervention is the specific function of the Insulin Pump from Medtronic® with the name "MiniMed® 670G (MMT-1780)" to deliver Insulin as medication. This Medtronic MiniMed 670G Insulin Pump in Auto Mode is an Hybrid closed loop (HCL) system including an Auto Mode function. It provides as intervention several additional effects concerning automatically insulin delivery by pump: e.g. in case of high values (or predicted) - more insulin will be administered automatically, in case of low values (or predicted) - the insulin infusion will be decreased a suspended and resumed again. The patients will wear the pump continuously.

Device: Medtronic MiniMed 670G Insulin Pump in Auto Mode

Sensor Augmented Pump (SAP) therapy

ACTIVE COMPARATOR

The Intervention is the specific therapy of the Sensor Augmented Insulin Pump "MiniMed® 670G" (MMT-1780) without Auto Mode. This Medtronic MiniMed 670G Insulin Pump without Auto Mode' is a Sensor Augmented Pump (SAP) therapy and means the addition of alerts according to high or low glucose values as well as trend arrows showing actual glucose trends to pump therapy. The patients will wear the pump also continuously, but have to respond manually after the alarm. There are no automatically steps from the pump.

Device: Medtronic MiniMed 670G Insulin Pump without Auto Mode

Interventions

Medtronic MiniMed 670G Insulin Pump in Auto Mode DEVICE

This kind of intervention will be part of the intensified insulin therapy for type 1 diabetic patients. The system will help to keep blood glucose in a defined range by automatic assisted adaption of insulin dosing.the HCL provides a lot more automatic functions to keep glucose in target compared to SAP.

Also known as: Hybrid Closed Loop (HCL) System

Therapy with Hybrid Closed Loop (HCL)

Medtronic MiniMed 670G Insulin Pump without Auto Mode DEVICE

Sensor augmented pump therapy means the addition of alerts according to high or low glucose values as well as trend arrows showing actual glucose trends to pump therapy. There is no automatic adaption of insulin dosing. The patients must respond manually after alarm or according to the trend arrows.

Also known as: Sensor Augmented Pump therapy without Auto Mode

Sensor Augmented Pump (SAP) therapy

Eligibility Criteria

• Age: 2 Years - 14 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• At time of screening: Subjects who are 2-14 years are determined by the investigator to be psychologically sound (e.g. no depression, anxiety disorder, traumatic stress disorder) in order to successfully participate in this study
• Subjects will be considered for enrollment in the study if they meet all of the following criteria:
• Subjects who are 2-14 years are determined by the investigator to have the appropriate, requisite support (family, caregiver or social network) to successfully participate in this study
• Subject is willing to wear the system continuously throughout the study
• Subject is willing to perform required sensor calibrations
• Total daily dose of Insulin \>8 U
• Subject has an A1C value \< 12.0% (as processed by Laboratory) at time of screening visit
• Subject must be on Pump therapy for \>3 months prior to Screening
• Subject may also be on sensor augmented pump therapy.
• If subject has celiac disease it has been adequately treated as proven by Transglutamase-Antibodies in normal range

You may not qualify if:

• Event of severe hypoglycemia in past 3 months (as per ISPAD Guideline Definition 2014: seizure or loss of consciousness.)
• Subject is unable to tolerate tape adhesive in the area of sensor placement
• Subject has any unresolved adverse skin condition in the area of sensor placement (e.g., psoriasis, rash, Staphylococcus infection)
• Women of child-bearing potential who have a positive pregnancy test at screening or plan to become pregnant during the course of the study
• Subject has had any of the following new diagnoses within 1 year of screening: myocardial infarction, unstable angina, coronary artery bypass surgery, coronary artery stenting, transient ischemic attack, cerebrovascular accident, angina, congestive heart failure, ventricular rhythm disturbances or thromboembolic disease
• Subject has a clinical significant abnormality (out of reference range, as processed by Laboratory) in thyroid-stimulating hormone (TSH) at time of screening visit
• Subjects suffering from Morbus Addison, heart failure \>NYHA II, chronic pulmonal disease \>GOLD II, chronic arterial insuffiency, known cancer disease, diabetic kidney disease, diabetic autonom or peropheral neuropathy
• Subject tests positive in the drug screen
• Subject has taken any oral, injectable, or IV steroids within 8 weeks prior time of screening visit, or plans to take any oral, injectable, or IV steroids during the course of the study; furthermore patients using antipsychotic drugs, antidepressive, ß-blocking agents are not permitted to participate
• Subject is actively participating in an investigational study (drug or device) wherein he/she has received treatment from an investigational study drug or investigational study device in the last 4 weeks
• Subject is currently abusing illicit drugs
• Subject is currently abusing prescription drugs
• Subject is currently abusing alcohol
• Subject is using pramlintide (Symlin) at time of screening
• Subject has a history of visual impairment which would not allow subject to participate in the study and perform all study procedures safely, as determined by the investigator

Sponsors & Collaborators

• Kinderkrankenhaus auf der Bult: lead

Study Sites (1)

Kinder - und Jugendkrankenhaus AUF DER BULT

Hanover, 30173, Germany

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Interventions

Drug Delivery Systems

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Drug Therapy; Therapeutics

Study Officials

• Thomas Danne, MD

  Diabetes Centre for Children and Adolescents, Kinderkrankenhaus AUF DER BULT

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 5, 2018
• First Posted: January 24, 2019
• Study Start: November 19, 2018
• Primary Completion: October 10, 2020
• Study Completion: October 10, 2020
• Last Updated: June 16, 2021

Record last verified: 2021-06

Locations

DE (1)