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

January 28, 2017 updated by: Bruria Sher, Assuta Hospital Systems

Telecare in Adults With Type 1 Diabetes Mellitus Treated by Insulin Pump - A Randomized Controlled Trial

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

  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. .

Study Type

Interventional

Enrollment (Actual)

66

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Ra'anana, Israel
        • Maccabi Healthcare Services

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

22 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Other: 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.
Active Comparator: Conventional therapy
3-month routine clinic visits
Other: Conventional therapy
3-month routine clinic visits

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in Glycosylated Hemoglobin (Hba1c)
Time Frame: From date of randomization every 3 months, up to one year
From date of randomization every 3 months, up to one year

Secondary Outcome Measures

Outcome Measure
Time Frame
Time spent on data analysis and telephone calls by team
Time Frame: 1 year
1 year
Number of severe hypoglycemic and diabetic ketoacidosis (DKA) events and hospitalizations
Time Frame: 1 year
1 year
Patients' quality of life
Time Frame: 1 year
1 year
Patients' satisfaction
Time Frame: 1 year
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assuta Hospital Systems

Collaborators

Maccabi Healthcare Services, Israel

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2013

Primary Completion (Actual)

November 1, 2016

Study Completion (Actual)

November 1, 2016

Study Registration Dates

First Submitted

June 18, 2013

First Submitted That Met QC Criteria

June 24, 2013

First Posted (Estimate)

June 26, 2013

Study Record Updates

Last Update Posted (Estimate)

January 31, 2017

Last Update Submitted That Met QC Criteria

January 28, 2017

Last Verified

January 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 71156

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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