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| Name | Class |
|---|---|
| Universitat de Girona | OTHER |
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The objective is to develop a novel system to predict and prevent nocturnal hypoglycemia in type 1 diabetic (T1D) patients, focused in patients with multiple daily injections (MDI) therapy. The general idea is to make use of previous-day information in the moment when patients go to sleep, and then predict if in the next following hours any hypoglycemic event will occur. If the system will have predicted any hypoglycemic event in that moment, it is expected that it will be able to warn the patient to take some action: such as reduce basal insulin dose or to consume a snack before sleep.
10 patients with T1D for more than five years will be included.
It is a longitudinal, prospective, interventional study in which every patient will use intermittently scanned Continuous Glucose Monitoring (isCGM) and a physical activity tracker during 12 weeks. Moreover, during this period, patients will store in a mobile application (Freestyle LibreLink) or in a reader information regarding their diabetes management activities, such as insulin delivery doses and meal consumption.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| isCGM and Physical exercise tracker | Experimental | Participants will perform CGM during 12 weeks using an isCGM (intermittently scanned Continuous Glucose Monitoring), Freestyle Libre, (Abbott Diabetes Care, Witney, Oxon, UK). Insulin dose (rapid-acting and long acting), carbohydrates and Self-monitoring blood glucose (SMBG) per day will be recorded by the patient in the reader or in the App (LibreLink, Abbott Diabetes Care, Witney, Oxon, UK). Moreover, participants will be instructed to collect data about moderate or high intensity exercise, illness and other disturbances occurring during the study period at home. Patients will wear a physical exercise tracker (Fitbit Alta HR® wristband (Fitbit, Inc., San Francisco, California, USA)) to track physiological variables such as heart rate, steps, activity level and sleep quality. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| isCGM (intermittently scanned Continuous Glucose Monitoring) | Device | Data collection |
|
| Measure | Description | Time Frame |
|---|---|---|
| Sensitivity (SE) and specificity (SP) to predict Level 1 hypoglycemia | Primary outcome will be sensitivity (SE) and specificity (SP) to predict Level 1 hypoglycemia. Level 1: a hypoglycemia alert glucose value between 54-70 mg/dL (3.0-3.9 mmol/L) with or without symptoms. A hypoglycemic event should be defined as follows. Beginning of a CGM event: readings below the threshold for at least 15 min are considered an event. For example, at least 15min, <70 mg/dL (3.9 mmol/L) to define a significant hypoglycemic event. End of a CGM event: readings for 15 min at >70 mg/dL (3.9 mmol/L). | 90 days |
| Measure | Description | Time Frame |
|---|---|---|
| Sensitivity (SE) and specificity (SP) to predict Level 2 hypoglycemia | Secondary outcome will be sensitivity (SE) and specificity (SP) to predict Level 2 hypoglycemia1. Level 2: a glucose level of <54mg/dL (3.0 mmol/L) with or without symptoms. A hypoglycemic event should be defined as follows. Beginning of a CGM event: readings below the threshold for at least 15 min are considered an event. For example, at least 15min, <54 mg/dL (3.0 mmol/L) to define a clinically significant hypoglycemic event. End of a CGM event: readings for 15 min at >70 mg/dL (3.9 mmol/L). A second hypoglycemic event outcome of prolonged hypoglycemia is considered when CGM levels are < 54 mg/dL (3.0 mmol/L) for consecutive 120 min or more. |
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Inclusion Criteria:
Patients > 18 years with Type 1 Diabetes:
Disease duration > 5 years
On multiple doses of insulin (MDI) therapy using a rapid acting insulin analogue as prandial insulin (lispro, aspart or glulisine) and any basal analogue as basal insulin.
A1c 6.5 - 9.5 %
Able to use an intermittently scanned continuous glucose monitoring (isCGM) system.
Performing >4 self-monitoring blood glucose (SMBG) per day
Using carb-counting
Providing an informed consent
No CGM user previously (during the last 3 months).
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ignacio Conget, MD, PhD | Hospital Clinic of Barcelona | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital ClÃnic de Barcelona | Barcelona | Catalonia | 08036 | Spain |
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Longitudinal, prospective, interventional study
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| Physical exercise tracker | Device | Data collection |
|
| 90 days |
| Predicted HbA1c from the sensor data | Predicted HbA1c from the sensor data | 90 days |
| standard deviation (SD) | Standard deviation (SD) | 90 days |
| Mean glucose | Mean glucose | 90 days |
| Level 3 hypoglycaemia | Number of Severe hypoglycemia Clinical diagnosis: event requiring assistance (level 3) | 90 days |
| Percentage of time in hypoglycemic ranges | Percentage of time in hypoglycemic ranges, mg/dL (mmol/L), %:
| 90 days |
| Percentage of time in target range | Percentage of time in target range, mg/dL (mmol/L), %:
| 90 days |
| Percentage of time in hyperglycemic range >180 | Percentage of time in hyperglycemic ranges, mg/dL (mmol/L), % Alert/elevated/monitor > 180 (>10) | 90 days |
| Percentage of time in hyperglycemic range >250 | Percentage of time in hyperglycemic ranges, mg/dL (mmol/L), % Clinically significant/very elevated > 250 (>13.9) | 90 days |
| Glucose variability LBGI | Low Blood Glucose Index (LBGI) | 90 days |
| Glucose variability HBGI | High Blood Glucose Index (HBGI) | 90 days |
| Number of Level 3: severe hypoglycemia | Number of Level 3: severe hypoglycemia. This denotes cognitive impairment requiring external assistance for recovery but is not defined by a specific glucose value. | 90 days |
| ID | Term |
|---|---|
| D007003 | Hypoglycemia |
| D003922 | Diabetes Mellitus, Type 1 |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D003920 | Diabetes Mellitus |
| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
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