MedTrace Logo

MD Logic Pump Advisor -Pediatric Study

NCT01308164 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 25

Last updated 2017-01-11

No results posted yet for this study

Summary

The objective of this feasibility study is to evaluate the efficacy and safety of automated determined Insulin pump settings (i.e., basal plan, correction factor, carbohydrate ration and insulin activity time) using the MD-Logic Pump Advisor in individuals with type 1 diabetes.

Study design:

Prospective study with two segments: (i) Pilot study, 30 days trial evaluating the MD-Logic pump advisor and (ii), randomized controlled trial (RCT), 30-78 days trial comparing MD-Logic pump advisor to the standard of care of patients with type 1 diabetes. The RCT will be initiated after the pilot segment (including data analysis). The pilot segment will include 15-30 pediatric patients. In the RCT, up to 105 (50 minors under this protocol and 55 adults under a separate protocol)eligible subjects will be enrolled to allow for 92 valuable subjects at the end of the study. The subject population will be randomly assigned 1:1 to either the intervention group or control group. At this pediatric sub study approximately 50 patients will participate and at the separate Adults study additional 55 adult patients will participate.

Conditions

Interventions

DEVICE

MD Logic Pump Advisor

Insulin pump setting (i.e basal plan, correction factor, carbohydrate ratio and insulin activity time)will be adjusted using the MD-LOgic Pump Advisor

Sponsors & Collaborators

  • Medtronic

    collaborator INDUSTRY

  • Rabin Medical Center

    lead OTHER

Principal Investigators

  • Moshe Phillip, Prof · Schenider Children's Medical

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
10 Years
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-03-31
Primary Completion
2017-01-31
Completion
2017-01-31

Countries

  • Israel
  • Slovenia

Study Locations

More Related Trials

Entities

Diseases
Companies

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 NCT01308164 on ClinicalTrials.gov