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MD Logic Pump Advisor- Adults Study

NCT01157923 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2017-01-11

No results posted yet for this study

Summary

Prospective, randomized, controlled, 30-78 days trial comparing MD-Logic pump algorithm to the standard of care of patients with type 1 diabetes.

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.The study will be consisted from two segments:(I)pilot study, 30-78 days trial evaluating the MD-Logic pump advisor and (II)randomized controlled 30-78 days trial comparing MD-Logic pump algorithm to the standard of care.In segment 1, the pilot study, the aim is to enroll 15-30 subjects without control group. In segment 2, the randomized controlled segment, the aim is to enroll 92 subjects, but enrolling up to 105 eligible subjects to allow for dropouts.

The randomized controled study segment will be initiated after the pilot segment.Each segment of the study will consist of 6 clinic visits taking place at intervals of 1-3 weeks, sum of 30-78 days study duration for each segment. Before each clinic visit, subjects will wear continuous glucose sensors for 6 days; the intervention group will have up to 4 iterations (e.g the pump setting will be reviewed and adjusted up to 4 times during the study period according to the MD-Logic Pump Advisor).For the control group (at segment 2 only), insulin pump settings will not be changed during the study period (patient's usual standard of care).

Conditions

Interventions

DEVICE

MD Logic Pump Advisor

Insulin pump settings (i.e., basal plan, correction factor, carbohydrate ration 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
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-07-31
Primary Completion
2016-07-31
Completion
2016-07-31

Countries

  • Israel
  • Slovenia

Study Locations

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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 NCT01157923 on ClinicalTrials.gov