Overview

This trial is active, not recruiting.

Condition type 1 diabetes mellitus
Treatments telecare, conventional therapy
Sponsor Assuta Hospital Systems
Collaborator Maccabi Healthcare Services, Israel
Start date October 2013
End date January 2017
Trial size 66 participants
Trial identifier NCT01887431, 71156

Summary

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking single blind (outcomes assessor)
Primary purpose treatment
Arm
(Experimental)
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.
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)
3-month routine clinic visits
conventional therapy
3-month routine clinic visits

Primary Outcomes

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

Secondary Outcomes

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

Eligibility Criteria

Male or female participants at least 22 years old.

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

Additional Information

Official title Telecare in Adults With Type 1 Diabetes Mellitus Treated by Insulin Pump - A Randomized Controlled Trial
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. .
Trial information was received from ClinicalTrials.gov and was last updated in January 2016.
Information provided to ClinicalTrials.gov by Assuta Hospital Systems.