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

NCT03815487 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2021-06-16

No results posted yet for this study

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

Interventions

DEVICE

Medtronic MiniMed 670G Insulin Pump in Auto Mode

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.

DEVICE

Medtronic MiniMed 670G Insulin Pump without Auto Mode

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.

Sponsors & Collaborators

  • Kinderkrankenhaus auf der Bult

    lead OTHER

Principal Investigators

  • Thomas Danne, MD · Diabetes Centre for Children and Adolescents, Kinderkrankenhaus AUF DER BULT

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
2 Years
Max Age
14 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-11-19
Primary Completion
2020-10-10
Completion
2020-10-10

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03815487 on ClinicalTrials.gov