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Completed

NCT Number: NCT01887431

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

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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Key information

Age range

22 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Maccabi Healthcare Services

Raanana, Israel

About this study

  • Objectives
  • To evaluate the effect of telecare on glycemic control for patients with type 1 diabetes (T1DM).
  • To assess the cost of telecare to Maccabi, the patient and the economy.
  • To assess patients' quality of life and satisfaction with telecare intervention.
  • To assess the effect of telecare intervention on insulin adjustment to consumed carbohydrates.
  • Working hypothesis Telecare can be used for efficient management of T1DM in adults using insulin pump, in lieu of frequent clinic visits.
  • 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

  • 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. .

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Telecare

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

Other

3-month routine clinic visits

Primary outcomes

  1. Change in Glycosylated Hemoglobin (Hba1c)

    Time frame: From date of randomization every 3 months, up to one year

Secondary outcomes

  1. Time spent on data analysis and telephone calls by team

    Time frame: 1 year

  2. Number of severe hypoglycemic and diabetic ketoacidosis (DKA) events and hospitalizations

    Time frame: 1 year

  3. Patients' quality of life

    Time frame: 1 year

  4. Patients' satisfaction

    Time frame: 1 year

Sponsors and collaborators

Lead sponsor

Assuta Hospital Systems

Other

Collaborators

  • Maccabi Healthcare Services, Israel

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2016
Study completion
2016
First posted
Jun 26, 2013
Registry last updated
Jan 31, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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