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| ID | Type | Description | Link |
|---|---|---|---|
| 19637 | Other Identifier | NSD |
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| Name | Class |
|---|---|
| Norwegian Diabetes Association | OTHER |
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The purpose of this study is to determine whether a real-time continuous glucose monitoring system is able to improve HbA1c in patients suffering from type 1 diabetes compared to conventional finger prick glucose measurements. In addition it will investigate whether number of episodes with serious hypoglycemia is changed in those same patients, and whether quality of life (health status and treatment satisfaction) increases.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Real-time glucose monitoring | Experimental | Use of Guardian REAL-Time Continuous Glucose Monitoring System, (Medtronic Minimed, Northridge, CA) for 1 month, followed by observation for 2 months. |
|
| Self-monitoring of plasma glucose | Active Comparator | Conventional self-monitoring of plasma glucose by finger-prick sampling for 1 month, followed by 1 month observation. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Guardian REAL-Time Continuous Glucose Monitoring System | Device | One group will use the glucose monitoring system for 1 month |
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| Measure | Description | Time Frame |
|---|---|---|
| Level of HbA1c concentration | 1 and 3 months post intervention. |
| Measure | Description | Time Frame |
|---|---|---|
| Quality of life assessed by SF-36, DTSQs and DTSQc | 1 and 3 months post intervention | |
| Number of hypoglycemic events | 1 and 3 months post intervention |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kristian J Fougner, MD | Departement of Endocrinology St. Olavs Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Endocrinology, St. Olavs Hospital | Trondheim | N-7006 | Norway |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22805265 | Result | Langeland LB, Salvesen O, Selle H, Carlsen SM, Fougner KJ. Short-term continuous glucose monitoring: effects on glucose and treatment satisfaction in patients with type 1 diabetes mellitus; a randomized controlled trial. Int J Clin Pract. 2012 Aug;66(8):741-747. doi: 10.1111/j.1742-1241.2012.02947.x. |
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| Conventional self-monitoring of plasma glucose | Other | Finger prick blood glucose measurements |
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| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| D007003 | Hypoglycemia |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
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