Clinical trial NCT03711656: Prediction and Prevention of Nocturnal Hypoglycemia in Persons With Type 1 Diabetes Using Machine Learning Techniques
Official title: Prediction and Prevention of Nocturnal Hypoglycemia in Persons With Type 1 Diabetes With Multiple Doses of Insulin Using Machine Learning Techniques.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type1diabetes
Hypoglycemia
Keywords: Type 1 diabetes
intermittent continuous glucose monitoring
hypoglycemia
machine learning
Lead sponsor: Hospital Clinic of Barcelona
Sponsor class: OTHER
Collaborators: name: Universitat de Girona
First posted: 2018-10-18
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Longitudinal, prospective, interventional study
Primary purpose: OTHER

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.


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
* 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.

Primary outcomes:
measure: Sensitivity (SE) and specificity (SP) to predict Level 1 hypoglycemia
timeFrame: 90 days
Secondary outcomes:
measure: Sensitivity (SE) and specificity (SP) to predict Level 2 hypoglycemia
timeFrame: 90 days
measure: Predicted HbA1c from the sensor data
timeFrame: 90 days
measure: standard deviation (SD)
timeFrame: 90 days
measure: Mean glucose
timeFrame: 90 days
measure: Level 3 hypoglycaemia
timeFrame: 90 days
measure: Percentage of time in hypoglycemic ranges
timeFrame: 90 days
measure: Percentage of time in target range
timeFrame: 90 days
measure: Percentage of time in hyperglycemic range >180
timeFrame: 90 days
measure: Percentage of time in hyperglycemic range >250
timeFrame: 90 days
measure: Glucose variability LBGI
timeFrame: 90 days
measure: Glucose variability HBGI
timeFrame: 90 days
measure: Number of Level 3: severe hypoglycemia
timeFrame: 90 days
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Hospital Clínic de Barcelona
state: Catalonia
Study officials:
affiliation: Hospital Clinic of Barcelona
name: Ignacio Conget, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: