Telecare in Type 1 Diabetes (T1D) Patients Treated by Insulin Pump

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

66 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-10-31

Study Completion Date

2016-11-30

Brief Summary

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The purpose of this study is to determine whether Telecare can be used for efficient management of adults with Type 1 Diabetes Mellitus using insulin pump, in lieu of frequent clinic visits.

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Detailed Description

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1. Objectives

1. To evaluate the effect of telecare on glycemic control for patients with type 1 diabetes (T1DM).
2. To assess the cost of telecare to Maccabi, the patient and the economy.
3. To assess patients' quality of life and satisfaction with telecare intervention.
4. To assess the effect of telecare intervention on insulin adjustment to consumed carbohydrates.
2. Working hypothesis Telecare can be used for efficient management of T1DM in adults using insulin pump, in lieu of frequent clinic visits.
3. Methodology A randomized controlled prospective trial for one year. Intervention group: Each patient will transmit glucometer and pump data electronically via a web site (Medtronic Carelink internet site www.carelink.minimed.com) to diabetes team and will receive feedback by telephone. Frequency of data transfer will be directly related to patients' metabolic control. In addition to data transmission Patient of the intervention group will be arriving during the intervention year for 3 clinic visit at the following time point : 0, 6 and 12 month.

Control group: 3-month routine clinic visits
4. Significance of the proposed research (its uniqueness and innovation) Telecare potentially offers a method for efficient continuous care management of patients with T1DM using insulin pump in lieu of clinic visits. It enables real time responses of clinical personnel and increases patient involvement. This trial will be the first telecare intervention lasting for one year to determine if treatment is as efficient as face to face visits, thus enabling cost reduction and time saving without affecting the quality of care. .

Conditions

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Type 1 Diabetes Mellitus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Telecare

Each patient will transmit glucometer and pump data electronically via a web site to diabetes team and will receive feedback by telephone. Frequency of data transfer will be directly related to patients' metabolic control.

Group Type EXPERIMENTAL

Telecare

Intervention Type OTHER

Each patient will transmit glucometer and pump data electronically via a web site (Medtronic Carelink internet site www.carelink.minimed.com) to diabetes team and will receive feedback by telephone. Frequency of data transfer will be directly related to patients' metabolic control. In addition to data transmission Patient of the intervention group will be arriving during the intervention year for 3 clinic visit at the following time point : 0, 6 and 12 month.

Conventional therapy

3-month routine clinic visits

Group Type ACTIVE_COMPARATOR

Conventional therapy

Intervention Type OTHER

3-month routine clinic visits

Interventions

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Telecare

Each patient will transmit glucometer and pump data electronically via a web site (Medtronic Carelink internet site www.carelink.minimed.com) to diabetes team and will receive feedback by telephone. Frequency of data transfer will be directly related to patients' metabolic control. In addition to data transmission Patient of the intervention group will be arriving during the intervention year for 3 clinic visit at the following time point : 0, 6 and 12 month.

Intervention Type OTHER

Conventional therapy

3-month routine clinic visits

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Patients with T1D lasted \>1 year, age 22 and up, using insulin pump
* Patients possessing a mobile phone and internet access

Exclusion Criteria

* Patients with Severe target organ damage
* Patients with Mental retardation
* Patients with Eating disorders
* Pregnant patients or patients planning pregnancy

Minimum Eligible Age

22 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No