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| Name | Class |
|---|---|
| GIF | UNKNOWN |
| Medtronic | INDUSTRY |
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Closed-loop systems are becoming an integral part of diabetes management. These systems were uniformly proven to improve glycemic control, reduce hyperglycemia and hypoglycemia while modestly reducing HbA1c levels and improving quality of life. While overnight control is close to optimal under closed loop control, postprandial hyperglycemia during daytime remains a challenge. The advanced hybrid closed loop system was designed with an improved auto-basal control and additional auto-bolus module that delivers correction boluses automatically. In addition, this system was developed to improve user experience by significantly reducing the amount of alarms and exits from Auto Mode. Therefore, this system might have an advance in treating hyperglycemia over the hybrid closed loop that controls glucose levels by modulation of insulin basal rate only. Therefore, we propose the current study that will compare 6 weeks glycemic control using hybrid closed loop versus advanced hybrid closed loop that add correction boluses among young children and adolescents.
The objective of this study is to evaluate and compare the safety and efficacy of 6 weeks glucose control using Hybrid Closed Loop (HCL-670G) compared to Advanced Hybrid Closed Loop System (AHCL- 670G) in young subjects with sub-optimally controlled type 1 diabetes. A total of 28 subjects (age 7-14 years) will be enrolled at two investigational centers.
At the end of the cross-over study participants will be offered with an extension period, during which they will be offered to use their preferred closed-loop system for another 3 months
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Medtronic Minimed 670G 3.0 HCL | Active Comparator | Hybrid closed loop system |
|
| Medtronic Minimed 670G 4.0 AHCL | Experimental | Advanced hybrid closed loop system |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Medtronic Minimed 670G 3.0 HCL | Device | Hybrid closed loop system |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of time of glucose sensor readings within 70 to 180 mg/dl | 6 weeks for each arm of the crossover, day 90 of the extension period | |
| Percentage of time of glucose sensor readings below 54 mg/dl | 6 weeks for each arm of the crossover |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of time of glucose levels spent below 70 mg/dl | 6 weeks for each arm of the crossover, day 90 of the extension period | |
| Percentage of time of glucose levels spent above 180 mg/dl | 6 weeks for each arm of the crossover, day 90 of the extension period |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of time of glucose sensor readings below 60 mg/dl | 6 weeks for each arm of the crossover | |
| Percentage of time of glucose sensor readings above 250mg/dl | 6 weeks for each arm of the crossover | |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Diabetes -Zentrum fuer kinder und jugendliche | Hanover | Germany | ||||
| Schneider Children's Medical Center of Israel |
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| Medtronic Minimed 670G 4.0 AHCL |
| Device |
Advanced hybrid closed loop system |
|
| Average glucose sensor readings | 6 weeks for each arm of the crossover, day 90 of the extension period |
| Standard deviation of glucose sensor readings | 6 week for each arm of the crossover, day 90 of the extension period |
| Fasting blood glucose levels | 6 weeks for each arm of the crossover, day 90 of the extension period |
| HbA1c change | 6 weeks for each arm of the crossover, day 90 of the extension period |
| Amount of total insulin delivery | 6 weeks for each arm of the crossover, day 90 of the extension period |
| Amount of basal insulin delivery | 6 weeks for each arm of the crossover, day 90 of the extension period |
| Amount of bolus insulin delivery | 6 weeks for each arm of the crossover, day 90 of the extension period |
| Serious Adverse Events (SAE) | 6 weeks for each arm of the crossover, day 90 of the extension period |
| Serious Adverse Device Events (SADE) | 6 weeks for each arm of the crossover, day 90 of the extension period |
| Unanticipated Adverse Device effects (UADE) | 6 weeks for each arm of the crossover, day 90 of the extension period |
| Incidence of Severe Hypoglycemia | 6 weeks for each arm of the crossover, day 90 of the extension period |
| incidence of DKA | 6 weeks for each arm of the crossover, day 90 of the extension period |
| Percentage of time of glucose sensor readings above 300mg/dl |
| 6 weeks for each arm of the crossover |
| percentage of time of using the closed loop system | 6 weeks for each arm of the crossover, day 90 of the extension period |
| INSPIRE questionnaire measures | The INSPIRE questionnaire measures Insulin delivery System's Perceptions, Ideas, Reflections and Expectations | 6 weeks for each arm of the crossover, day 90 of the extension period |
| Petah Tikva |
| 4920235 |
| Israel |
| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| 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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