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

NCT03711656 | Completed

• 1 other identifier: Nocturnal Hypoglycemia
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Type1diabetes; Hypoglycemia

Keywords

Type 1 diabetes; intermittent continuous glucose monitoring; hypoglycemia; machine learning

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (12)

• Sensitivity (SE) and specificity (SP) to predict Level 2 hypoglycemia

  90 days

• Predicted HbA1c from the sensor data

  90 days

• standard deviation (SD)

  90 days

• Mean glucose

  90 days

• Level 3 hypoglycaemia

  90 days

Study Arms (1)

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.

Device: isCGM (intermittently scanned Continuous Glucose Monitoring); Device: Physical exercise tracker

Interventions

isCGM (intermittently scanned Continuous Glucose Monitoring) DEVICE

Data collection

isCGM and Physical exercise tracker

Physical exercise tracker DEVICE

Data collection

isCGM and Physical exercise tracker

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hospital Clinic of Barcelona: lead
• Universitat de Girona: collaborator

Study Sites (1)

Hospital Clínic de Barcelona

Barcelona, Catalonia, 08036, Spain

Location

MeSH Terms

Conditions

Hypoglycemia; Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Diabetes Mellitus; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Ignacio Conget, MD, PhD

  Hospital Clinic of Barcelona

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Endocrinology and Nutrition Department, Principal Investigator

Model Details: Longitudinal, prospective, interventional study

Study Record Dates

• First Submitted: October 10, 2018
• First Posted: October 18, 2018
• Study Start: October 10, 2018
• Primary Completion: March 1, 2019
• Study Completion: April 30, 2019
• Last Updated: August 7, 2019

Record last verified: 2019-08

Locations

ES (1)