Telecare in Adults With Type 1 Diabetes Mellitus Treated by Insulin Pump - A Randomized Controlled Trial
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Type 1 Diabetes Mellitus
- Sponsor
- Assuta Hospital Systems
- Enrollment
- 66
- Locations
- 1
- Primary Endpoint
- Change in Glycosylated Hemoglobin (Hba1c)
- Status
- Completed
- Last Updated
- 9 years ago
Overview
Brief 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.
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. .
Investigators
Bruria Sher
Dietitian
Assuta Hospital Systems
Eligibility Criteria
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
Outcomes
Primary Outcomes
Change in Glycosylated Hemoglobin (Hba1c)
Time Frame: From date of randomization every 3 months, up to one year
Secondary Outcomes
- 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)