Hypoglycemia, Type1diabetes
Conditions
Keywords
Type 1 diabetes, intermittent continuous glucose monitoring, hypoglycemia, machine learning
Brief summary
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.
Interventions
DEVICEisCGM (intermittently scanned Continuous Glucose Monitoring)
Data collection
DEVICEPhysical exercise tracker
Data collection
Sponsors
Universitat de Girona
Hospital Clinic of Barcelona
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Intervention model description
Longitudinal, prospective, interventional study
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients \> 18 years with Type 1 Diabetes: * \> 4 hypoglycemia / week (\< 70 mg/dl, including day and night), last 2 weeks and / or * One severe hypoglycemia during the last year and / or * Hypoglycemia unawareness (Clarke Test \>3) * 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
* Patients with a previous Diabetic Ketoacidosis (DKA) episode in the previous 6 months. * Patients with a severe hypoglycemia in the previous 6 months. * Severe diabetic complications or comorbidities: eye, renal, cardiovascular...from the clinicians point of view. * Pregnancy and breastfeeding. * History of drug or alcohol abuse. * Scheduled surgery during the study period. * Mental conditions that prevent the subject to understand the nature, purpose and possible consequences of the study. * Subjects those are unlikely to meet the clinical study protocol, eg uncooperative attitude, inability to return for follow-up visits, or poor probability of completing the study. * Using an experimental drug or device during the past 30 days.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Sensitivity (SE) and specificity (SP) to predict Level 1 hypoglycemia | 90 days | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Predicted HbA1c from the sensor data | 90 days | Predicted HbA1c from the sensor data |
| standard deviation (SD) | 90 days | Standard deviation (SD) |
| Mean glucose | 90 days | Mean glucose |
| Level 3 hypoglycaemia | 90 days | Number of Severe hypoglycemia Clinical diagnosis: event requiring assistance (level 3) |
| Percentage of time in hypoglycemic ranges | 90 days | Percentage of time in hypoglycemic ranges, mg/dL (mmol/L), %: * Clinically significant/very low/immediate action required \<54 (\<3.0) (level 2) * Alert/low/monitor 70-54 (3.9-3.0) (level 1) |
| Sensitivity (SE) and specificity (SP) to predict Level 2 hypoglycemia | 90 days | 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. |
| Percentage of time in hyperglycemic range >180 | 90 days | Percentage of time in hyperglycemic ranges, mg/dL (mmol/L), % Alert/elevated/monitor \> 180 (\>10) |
| Percentage of time in hyperglycemic range >250 | 90 days | Percentage of time in hyperglycemic ranges, mg/dL (mmol/L), % Clinically significant/very elevated \> 250 (\>13.9) |
| Glucose variability LBGI | 90 days | Low Blood Glucose Index (LBGI) |
| Glucose variability HBGI | 90 days | High Blood Glucose Index (HBGI) |
| Number of Level 3: severe hypoglycemia | 90 days | Number of Level 3: severe hypoglycemia. This denotes cognitive impairment requiring external assistance for recovery but is not defined by a specific glucose value. |
| Percentage of time in target range | 90 days | Percentage of time in target range, mg/dL (mmol/L), %: * Default 70-180 (3.9-10.0) * Secondary 70-140 (3.9-7.8) |
Countries
Spain
Outcome results
None listed