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The potential of currently available diabetes technologies could be further exploited. The investigators propose that sensor-augmented insulin pump therapy may be improved by continuous correction, i.e. continuous evaluation of the need for correction boluses. In practice, this is carried out by running the bolus calculator every 10 minutes. The glucose sensor will provide the bolus calculator with glucose input. Many times, the bolus calculator will come to the result that no insulin is needed. However, when the blood glucose is above the pre-set target value and a correction bolus is needed, an appropriate bolus is automatically delivered by the insulin pump.
The investigators hypothesize that sensor-augmented continuous correction insulin pump therapy can reduce hyperglycemia without increasing the risk of hypoglycemia in patients with type 1 diabetes.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Continuous correction | Experimental | The insulin pump is set to automatically deliver the patient's usual insulin basal rate. The insulin pump bolus calculator is run every 10 minutes by the attending physician. Bolus calculations are based on glucose sensor values. |
|
| Control | No Intervention | Regular sensor-augmented pump therapy. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Continuous Correction | Procedure |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of time CGM values are in the target range 3.9-8.0 mmol/l in the time period 8:00-17:00. | The primary outcome is difference in the percentage of time CGM values are in the target range 3.9-8.0 mmol/l in the time period 8:00-17:00 on CC-days and Control-days. | Every 5 min for 9 hours on each study day. |
| Measure | Description | Time Frame |
|---|---|---|
| Mean CGM glucose value. | Every 5 min for 9 hours on each study day. | |
| Percentage of time when CGM values are < 3.9 mmol/l. | Every 5 min for 9 hours on each study day. | |
| Measure | Description | Time Frame |
|---|---|---|
| Mean absolute relative difference. | CGM accuracy will be evaluated with Hemocue glucose values as reference (mean absolute relative difference). | Every 5 min for 9 hours on each study day. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Signe Schmidt, MD, PhD | Hvidovre University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hvidovre University Hospital | Hvidovre | 2650 | Denmark |
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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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| Percentage of time when CGM values are > 8.0 mmol/l. |
| Every 5 min for 9 hours on each study day. |
| CGM standard deviation. | Every 5 min for 9 hours on each study day. |
| Number of hypoglycemic episodes. | Every 5 min for 9 hours on each study day. |
| Amount of insulin delivered. | Every 30 min for 9 hours on each study day. |
| Positive Incremental Area Under the Curve | Every 5 min for 9 hours on each study day. |
| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |