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Trial record 5 of 872 for:    hypoglycemia | "Diabetes Mellitus, Insulin-Dependent"

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

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ClinicalTrials.gov Identifier: NCT03711656
Recruitment Status : Completed
First Posted : October 18, 2018
Last Update Posted : August 7, 2019
Sponsor:
Collaborator:
Universitat de Girona
Information provided by (Responsible Party):
Ignacio Conget, Hospital Clinic of Barcelona

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.


Condition or disease Intervention/treatment Phase
Type1diabetes Hypoglycemia Device: isCGM (intermittently scanned Continuous Glucose Monitoring) Device: Physical exercise tracker Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Intervention Model: Single Group Assignment
Intervention Model Description: Longitudinal, prospective, interventional study
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Prediction and Prevention of Nocturnal Hypoglycemia in Persons With Type 1 Diabetes With Multiple Doses of Insulin Using Machine Learning Techniques.
Actual Study Start Date : October 10, 2018
Actual Primary Completion Date : March 1, 2019
Actual Study Completion Date : April 30, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: isCGM and Physical exercise tracker

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)
Data collection

Device: Physical exercise tracker
Data collection




Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Sensitivity (SE) and specificity (SP) to predict Level 2 hypoglycemia [ Time Frame: 90 days ]

    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.


  2. Predicted HbA1c from the sensor data [ Time Frame: 90 days ]
    Predicted HbA1c from the sensor data

  3. standard deviation (SD) [ Time Frame: 90 days ]
    Standard deviation (SD)

  4. Mean glucose [ Time Frame: 90 days ]
    Mean glucose

  5. Level 3 hypoglycaemia [ Time Frame: 90 days ]
    Number of Severe hypoglycemia Clinical diagnosis: event requiring assistance (level 3)

  6. Percentage of time in hypoglycemic ranges [ Time Frame: 90 days ]

    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)

  7. Percentage of time in target range [ Time Frame: 90 days ]

    Percentage of time in target range, mg/dL (mmol/L), %:

    • Default 70-180 (3.9-10.0)
    • Secondary 70-140 (3.9-7.8)

  8. Percentage of time in hyperglycemic range >180 [ Time Frame: 90 days ]
    Percentage of time in hyperglycemic ranges, mg/dL (mmol/L), % Alert/elevated/monitor > 180 (>10)

  9. Percentage of time in hyperglycemic range >250 [ Time Frame: 90 days ]
    Percentage of time in hyperglycemic ranges, mg/dL (mmol/L), % Clinically significant/very elevated > 250 (>13.9)

  10. Glucose variability LBGI [ Time Frame: 90 days ]
    Low Blood Glucose Index (LBGI)

  11. Glucose variability HBGI [ Time Frame: 90 days ]
    High Blood Glucose Index (HBGI)

  12. Number of Level 3: severe hypoglycemia [ Time Frame: 90 days ]
    Number of Level 3: severe hypoglycemia. This denotes cognitive impairment requiring external assistance for recovery but is not defined by a specific glucose value.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03711656


Locations
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Spain
Hospital Clínic de Barcelona
Barcelona, Catalonia, Spain, 08036
Sponsors and Collaborators
Hospital Clinic of Barcelona
Universitat de Girona
Investigators
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Principal Investigator: Ignacio Conget, MD, PhD Hospital Clínic de Barcelona

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Responsible Party: Ignacio Conget, Head of Endocrinology and Nutrition Department, Principal Investigator, Hospital Clinic of Barcelona
ClinicalTrials.gov Identifier: NCT03711656     History of Changes
Other Study ID Numbers: Nocturnal Hypoglycemia
First Posted: October 18, 2018    Key Record Dates
Last Update Posted: August 7, 2019
Last Verified: August 2019

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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

Keywords provided by Ignacio Conget, Hospital Clinic of Barcelona:
Type 1 diabetes
intermittent continuous glucose monitoring
hypoglycemia
machine learning

Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 1
Hypoglycemia
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases