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The aim of the study is to prove whether the use of the SmartGuard feature of the MiniMed system significantly reduces hypoglycemic excursions and thus provide proactive protection to the user.
This is randomized two-arm parallel controlled open label study that will be conducted at two sites, in Slovenia and Israel. It is an investigator initiated pediatric clinical study.
Study will be conducted on pediatric population during two weeks, following a 3 day Run-in period that will allow the patients to get familiar with study device and CGM (SmartGuard OFF).
Patients will be asked to continuously wear the study device for 14 days, which will be set up by study staff according to randomization in the specific group. They will be provided with a diary for entering their daily activity, food consumption (carb count) and eventual adverse events.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Suspend Before Low feature turned ON | Experimental | MiniMedâ„¢ 640G system with the "Suspend Before Low" feature turned ON; continuously set on at 3,6 mmol/L (65 mg/dL). "Suspend On Low" Alert and "Resume Basal Alert" for the SmartGuard group should be set OFF. Administered intervention: Medtronic MiniMedâ„¢ 640G system |
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| Suspend Before Low feature turned OFF | Active Comparator | MiniMedâ„¢ 640G system with the "Suspend Before Low" and "Suspend On Low" features are both turned OFF; "Alert On Low" is set at 65 mg/dL (3,6 mmol/L). "Resume Basal Alert" should be set OFF as well. Administered intervention: Medtronic MiniMedâ„¢ 640G system |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Medtronic MiniMedâ„¢ 640G system | Device | The MiniMedâ„¢ 640G system is indicated for the continuous delivery of insulin, for continuous or periodic monitoring of glucose levels in the fluid under the skin, with a feature for a prediction of low or high glucose episodes. |
| Measure | Description | Time Frame |
|---|---|---|
| Significant between-group difference in number of hypoglycemic events | After all patients completed 14 days of study treatment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Tadej Battelino, PhD | University of Ljubljana, Faculty of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Schneider Children's Medical Center of Israel, The Jesse Z and Sara Lea Shafer Institute for Endocrinology and Diabetes | Petah Tikva | 4920235 | Israel |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28351897 | Derived | Battelino T, Nimri R, Dovc K, Phillip M, Bratina N. Prevention of Hypoglycemia With Predictive Low Glucose Insulin Suspension in Children With Type 1 Diabetes: A Randomized Controlled Trial. Diabetes Care. 2017 Jun;40(6):764-770. doi: 10.2337/dc16-2584. Epub 2017 Mar 28. |
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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 |
|---|---|
| D016503 | Drug Delivery Systems |
| ID | Term |
|---|---|
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
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| University of Ljubljana, Faculty of Medicine | Ljubljana | 1000 | Slovenia |
| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |