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

Type 1 Diabetes Mellitus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01887431
• Other study ID #: 71156
• Status: Completed
• Phase: N/A
• First received: June 18, 2013
• Last updated: January 28, 2017
• Start date: October 2013
• Est. completion date: November 2016

Study information

• Verified date: January 2017
• Source: Assuta Hospital Systems
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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. .

Recruitment information / eligibility

• Status: Completed
• Enrollment: 66
• Est. completion date: November 2016
• Est. primary completion date: November 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 22 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Type 1 Diabetes Mellitus

Intervention

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.
• Conventional therapy
3-month routine clinic visits

Locations

Country	Name	City	State
Israel	Maccabi Healthcare Services	Ra'anana

Sponsors (2)

Lead Sponsor	Collaborator
Assuta Hospital Systems	Maccabi Healthcare Services, Israel

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Glycosylated Hemoglobin (Hba1c)		From date of randomization every 3 months, up to one year
Secondary	Time spent on data analysis and telephone calls by team		1 year
Secondary	Number of severe hypoglycemic and diabetic ketoacidosis (DKA) events and hospitalizations		1 year
Secondary	Patients' quality of life		1 year
Secondary	Patients' satisfaction		1 year