Prediction and Prevention of Nocturnal Hypoglycemia in Persons With Type 1 Diabetes Using Machine Learning Techniques

Hypoglycemia Clinical Trial

Official title:

Prediction and Prevention of Nocturnal Hypoglycemia in Persons With Type 1 Diabetes With Multiple Doses of Insulin Using Machine Learning Techniques.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03711656
• Other study ID #: Nocturnal Hypoglycemia
• Status: Completed
• Phase: N/A
• Start date: October 10, 2018
• Est. completion date: April 30, 2019

Study information

• Verified date: August 2019
• Source: Hospital Clinic of Barcelona
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: April 30, 2019
• Est. primary completion date: March 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Hypoglycemia
• Type1diabetes

Intervention

Device:
• isCGM (intermittently scanned Continuous Glucose Monitoring)
Data collection
• Physical exercise tracker
Data collection

Locations

Country	Name	City	State
Spain	Hospital Clínic de Barcelona	Barcelona	Catalonia

Sponsors (2)

Lead Sponsor	Collaborator
Hospital Clinic of Barcelona	Universitat de Girona

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	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.	90 days
Secondary	Predicted HbA1c from the sensor data	Predicted HbA1c from the sensor data	90 days
Secondary	standard deviation (SD)	Standard deviation (SD)	90 days
Secondary	Mean glucose	Mean glucose	90 days
Secondary	Level 3 hypoglycaemia	Number of Severe hypoglycemia Clinical diagnosis: event requiring assistance (level 3)	90 days
Secondary	Percentage of time in hypoglycemic ranges	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)	90 days
Secondary	Percentage of time in target range	Percentage of time in target range, mg/dL (mmol/L), %: Default 70-180 (3.9-10.0); Secondary 70-140 (3.9-7.8)	90 days
Secondary	Percentage of time in hyperglycemic range >180	Percentage of time in hyperglycemic ranges, mg/dL (mmol/L), % Alert/elevated/monitor > 180 (>10)	90 days
Secondary	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
Secondary	Glucose variability LBGI	Low Blood Glucose Index (LBGI)	90 days
Secondary	Glucose variability HBGI	High Blood Glucose Index (HBGI)	90 days
Secondary	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