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

Study Overview
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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.

Detailed Description
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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. .

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

Conditions
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Type 1 Diabetes Mellitus

Intervention / Treatment
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* Other: Telecare
* Other: Conventional therapy


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 22 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Telecare<br>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<br>* 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.<br>|
| Active Comparator: Conventional therapy<br>3-month routine clinic visits | Other: Conventional therapy<br>* 3-month routine clinic visits<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Diabetes Mellitus, Type 1, Adult, Insulin Infusion Systems, Telecare