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OpenTrials
Completed

NCT Number: NCT03711656

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

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.

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Key information

Conditions

Type1diabetes Autoimmune Diseases Diabetes Mellitus Diabetes Mellitus, Type 1 Endocrine System Diseases Glucose Metabolism Disorders Hypoglycemia Immune System Diseases Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital Clínic de Barcelona

Barcelona, Catalonia, 08036, Spain

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

isCGM (intermittently scanned Continuous Glucose Monitoring)

Device

Data collection

Physical exercise tracker

Device

Data collection

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Hospital Clinic of Barcelona

Other

Collaborators

  • Universitat de Girona

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Oct 18, 2018
Registry last updated
Aug 7, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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