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Evaluation of Automated Insulin Pump Settings Using the Advisor Pro (Previously Called) MD-Logic Pump Advisor-three Segments Study

NCT02617160 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2018-12-21

No results posted yet for this study

Summary

Pump therapy is gaining popularity as a treatment mode for patients with type 1 diabetes. Utilizing pump therapy requires the development and application of a new spectrum of theoretical knowledge and practical skills by the patient. Furthermore, occasionally there is a need to tailor the pump settings, i.e. the insulin correction factor, carbohydrate ratio, basal plan and insulin activity time, in order to optimize and improve glucose control. These adjustments are based on collected information including insulin delivery, blood glucose measurements, continuous glucose monitoring data, meals and so on. Analyzing this multitude of information and data is overwhelming for many of the patients, caregivers and health care providers. Unfortunately, not all physicians have the needed expertise to fully fulfill this task, and for those who do, it is time consuming. Thus, a summary of the data with insulin dose adjustment suggestions is missing. An automated tool for pump setting adjustments will improve glycemic control without escalating the burden on patients and the health care system. Such advisor can assist the professional team during routine follow-up and the patients between visits.

To address this challenge, the investigators developed the MD-Logic Pump Advisor (MDPA), which automatically analyses treatment information, learns patient's needs and accordingly suggests adjustments in insulin dosing. The MDPA uses information gathered from glucose monitoring, insulin dosing and meal data during daily routine home care. Following a 5 minute data collection and analysis, the algorithm learns and suggests pump-setting changes for optimization of glucose control.

This study aims to evaluate the efficacy and safety of the Advisor Pro. The study will include three segments:

Segment A - a randomized controlled parallel study, Segment B- a clinic prospective study during which the Advisor Pro will be evaluated during routine clinical visits as an added tool for physicians and Segment C- a clinical prospective parallel study for patients treated with pump therapy and SMBG only.

Conditions

Interventions

DEVICE

MD-Logic Pump Advisor

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

OTHER

Control Group

Insulin pump settings (i.e, basal plan, correction factor, carbohydrate ratio and insulin activity time) will be adjusted by the medical team in accordance to the regular practice

Sponsors & Collaborators

  • Novo Nordisk A/S

    collaborator INDUSTRY

  • DreaMed

    collaborator INDUSTRY

  • Rabin Medical Center

    lead OTHER

Principal Investigators

  • Moshe Phillip, MD, Prof · Rabin Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
6 Years
Max Age
30 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-05-31
Primary Completion
2018-12-31
Completion
2018-12-31

Countries

  • Israel

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 NCT02617160 on ClinicalTrials.gov