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| Name | Class |
|---|---|
| Maccabi Healthcare Services, Israel | OTHER |
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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.
Objectives
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. .
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Telecare | 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. |
|
| Conventional therapy | Active Comparator | 3-month routine clinic visits |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Glycosylated Hemoglobin (Hba1c) | From date of randomization every 3 months, up to one year |
| 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 | |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Maccabi Healthcare Services | Raanana | Israel |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30783823 | Derived | Yaron M, Sher B, Sorek D, Shomer M, Levek N, Schiller T, Gaspar M, Frumkin Ben-David R, Mazor-Aronovitch K, Tish E, Shapira Y, Pinhas-Hamiel O. A randomized controlled trial comparing a telemedicine therapeutic intervention with routine care in adults with type 1 diabetes mellitus treated by insulin pumps. Acta Diabetol. 2019 Jun;56(6):667-673. doi: 10.1007/s00592-019-01300-1. Epub 2019 Feb 19. |
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| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D017216 | Telemedicine |
| ID | Term |
|---|---|
| D003695 | Delivery of Health Care |
| D010346 | Patient Care Management |
| D006298 | Health Services Administration |
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|
| Conventional therapy | Other | 3-month routine clinic visits |
|
| Patients' quality of life |
| 1 year |
| Patients' satisfaction | 1 year |
| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |