Prediction and Prevention of Nocturnal Hypoglycemia in Persons With Type 1 Diabetes With Multiple Doses of Insulin Using Machine Learning Techniques.
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Type1diabetes
- Sponsor
- Hospital Clinic of Barcelona
- Enrollment
- 10
- Locations
- 1
- Primary Endpoint
- Sensitivity (SE) and specificity (SP) to predict Level 1 hypoglycemia
- Status
- Completed
- Last Updated
- 6 years ago
Overview
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.
Investigators
Ignacio Conget
Head of Endocrinology and Nutrition Department, Principal Investigator
Hospital Clinic of Barcelona
Eligibility Criteria
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
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.
Outcomes
Primary Outcomes
Sensitivity (SE) and specificity (SP) to predict Level 1 hypoglycemia
Time Frame: 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 Outcomes
- Percentage of time in target range(90 days)
- Predicted HbA1c from the sensor data(90 days)
- Level 3 hypoglycaemia(90 days)
- Mean glucose(90 days)
- Glucose variability LBGI(90 days)
- Number of Level 3: severe hypoglycemia(90 days)
- Sensitivity (SE) and specificity (SP) to predict Level 2 hypoglycemia(90 days)
- Percentage of time in hypoglycemic ranges(90 days)
- Percentage of time in hyperglycemic range >250(90 days)
- Glucose variability HBGI(90 days)
- standard deviation (SD)(90 days)
- Percentage of time in hyperglycemic range >180(90 days)