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

Primary Purpose

Type1diabetes, Hypoglycemia

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
isCGM (intermittently scanned Continuous Glucose Monitoring)
Physical exercise tracker
Sponsored by
Hospital Clinic of Barcelona
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Type1diabetes focused on measuring Type 1 diabetes, intermittent continuous glucose monitoring, hypoglycemia, machine learning

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Hospital Clínic de Barcelona

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

isCGM and Physical exercise tracker

Arm Description

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.

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

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.
Predicted HbA1c from the sensor data
Predicted HbA1c from the sensor data
standard deviation (SD)
Standard deviation (SD)
Mean glucose
Mean glucose
Level 3 hypoglycaemia
Number of Severe hypoglycemia Clinical diagnosis: event requiring assistance (level 3)
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)
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)
Percentage of time in hyperglycemic range >180
Percentage of time in hyperglycemic ranges, mg/dL (mmol/L), % Alert/elevated/monitor > 180 (>10)
Percentage of time in hyperglycemic range >250
Percentage of time in hyperglycemic ranges, mg/dL (mmol/L), % Clinically significant/very elevated > 250 (>13.9)
Glucose variability LBGI
Low Blood Glucose Index (LBGI)
Glucose variability HBGI
High Blood Glucose Index (HBGI)
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.

Full Information

First Posted
October 10, 2018
Last Updated
August 6, 2019
Sponsor
Hospital Clinic of Barcelona
Collaborators
Universitat de Girona
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1. Study Identification

Unique Protocol Identification Number
NCT03711656
Brief Title
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

2. Study Status

Record Verification Date
August 2019
Overall Recruitment Status
Completed
Study Start Date
October 10, 2018 (Actual)
Primary Completion Date
March 1, 2019 (Actual)
Study Completion Date
April 30, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hospital Clinic of Barcelona
Collaborators
Universitat de Girona

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type1diabetes, Hypoglycemia
Keywords
Type 1 diabetes, intermittent continuous glucose monitoring, hypoglycemia, machine learning

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Longitudinal, prospective, interventional study
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
isCGM and Physical exercise tracker
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
isCGM (intermittently scanned Continuous Glucose Monitoring)
Intervention Description
Data collection
Intervention Type
Device
Intervention Name(s)
Physical exercise tracker
Intervention Description
Data collection
Primary Outcome Measure Information:
Title
Sensitivity (SE) and specificity (SP) to predict Level 1 hypoglycemia
Description
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).
Time Frame
90 days
Secondary Outcome Measure Information:
Title
Sensitivity (SE) and specificity (SP) to predict Level 2 hypoglycemia
Description
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.
Time Frame
90 days
Title
Predicted HbA1c from the sensor data
Description
Predicted HbA1c from the sensor data
Time Frame
90 days
Title
standard deviation (SD)
Description
Standard deviation (SD)
Time Frame
90 days
Title
Mean glucose
Description
Mean glucose
Time Frame
90 days
Title
Level 3 hypoglycaemia
Description
Number of Severe hypoglycemia Clinical diagnosis: event requiring assistance (level 3)
Time Frame
90 days
Title
Percentage of time in hypoglycemic ranges
Description
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)
Time Frame
90 days
Title
Percentage of time in target range
Description
Percentage of time in target range, mg/dL (mmol/L), %: Default 70-180 (3.9-10.0) Secondary 70-140 (3.9-7.8)
Time Frame
90 days
Title
Percentage of time in hyperglycemic range >180
Description
Percentage of time in hyperglycemic ranges, mg/dL (mmol/L), % Alert/elevated/monitor > 180 (>10)
Time Frame
90 days
Title
Percentage of time in hyperglycemic range >250
Description
Percentage of time in hyperglycemic ranges, mg/dL (mmol/L), % Clinically significant/very elevated > 250 (>13.9)
Time Frame
90 days
Title
Glucose variability LBGI
Description
Low Blood Glucose Index (LBGI)
Time Frame
90 days
Title
Glucose variability HBGI
Description
High Blood Glucose Index (HBGI)
Time Frame
90 days
Title
Number of Level 3: severe hypoglycemia
Description
Number of Level 3: severe hypoglycemia. This denotes cognitive impairment requiring external assistance for recovery but is not defined by a specific glucose value.
Time Frame
90 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ignacio Conget, MD, PhD
Organizational Affiliation
Hospital Clinic of Barcelona
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital Clínic de Barcelona
City
Barcelona
State/Province
Catalonia
ZIP/Postal Code
08036
Country
Spain

12. IPD Sharing Statement

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

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