Type1diabetesNCT03711656
Prediction and Prevention of Nocturnal Hypoglycemia in Persons With Type 1 Diabetes Using Machine Learning Techniques
A study testing isCGM (intermittently scanned Continuous Glucose Monitoring) and Physical exercise tracker in people with Type1diabetes and Hypoglycemia, run by Hospital Clinic of Barcelona at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Type1diabetes, Hypoglycemia
- What is being tested?
- isCGM (intermittently scanned Continuous Glucose Monitoring) and Physical exercise tracker
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteSpain
- Study dates
- 10 Oct 2018to 30 Apr 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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).
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prediction and Prevention of Nocturnal Hypoglycemia in Persons With Type 1 Diabetes With Multiple Doses of Insulin 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.
- Conditions
- Type1diabetes, Hypoglycemia
- Being tested
- isCGM (intermittently scanned Continuous Glucose Monitoring), Physical exercise tracker
- Keywords
- Type 1 diabetes, intermittent continuous glucose monitoring, hypoglycemia, machine learning
- Medical subject headings
- Hypoglycemia, Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
isCGM (intermittently scanned Continuous Glucose Monitoring)Device
Data collection
Physical exercise trackerDevice
Data collection
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: isCGM (intermittently scanned Continuous Glucose Monitoring); Device: Physical exercise tracker |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 90 days
Secondary outcomes (12)
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.
Measured: 90 days
Predicted HbA1c from the sensor data
Predicted HbA1c from the sensor data
Measured: 90 days
standard deviation (SD)
Standard deviation (SD)
Measured: 90 days
Mean glucose
Mean glucose
Measured: 90 days
Level 3 hypoglycaemia
Number of Severe hypoglycemia Clinical diagnosis: event requiring assistance (level 3)
Measured: 90 days
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)
Measured: 90 days
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)
Measured: 90 days
Percentage of time in hyperglycemic range >180
Percentage of time in hyperglycemic ranges, mg/dL (mmol/L), % Alert/elevated/monitor > 180 (>10)
Measured: 90 days
Percentage of time in hyperglycemic range >250
Percentage of time in hyperglycemic ranges, mg/dL (mmol/L), % Clinically significant/very elevated > 250 (>13.9)
Measured: 90 days
Glucose variability LBGI
Low Blood Glucose Index (LBGI)
Measured: 90 days
Glucose variability HBGI
High Blood Glucose Index (HBGI)
Measured: 90 days
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.
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2018
- Study start10 Oct 2018
- Primary completion1 Mar 2019
- Study completion30 Apr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type1diabetesStudies of the same condition, open and under way.
- More trials run by Hospital Clinic of BarcelonaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Longitudinal, prospective, interventional study
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Clinic of Barcelona
- Sponsor type
- University, hospital or other
- Collaborators
- Universitat de Girona
- Responsible party
- Principal investigator, Ignacio Conget, Hospital Clinic of Barcelona
- Investigators
- Ignacio Conget, MD, PhD, Principal investigator, Hospital Clinic of Barcelona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03711656
- Sponsor's protocol ID
- Nocturnal Hypoglycemia
- Status last verified
- Aug 2019
- First submitted
- 10 Oct 2018
- Last updated
- 7 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prediction and Prevention of Nocturnal Hypoglycemia in Persons With Type 1 Diabetes With Multiple Doses of Insulin Using Machine Learning Techniques.
- ClinicalTrials.gov ID
- NCT03711656
- Acronym / sponsor ID
- Nocturnal Hypoglycemia
- Conditions
- Type1diabetes, Hypoglycemia
- Keywords
- Type 1 diabetes, intermittent continuous glucose monitoring, hypoglycemia, machine learning
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Hospital Clinic of BarcelonaUniversity, hospital or other
- Collaborators
- Universitat de Girona
- Study start
- 10 Oct 2018 (actual)
- Primary completion
- 1 Mar 2019 (actual)
- Study completion
- 30 Apr 2019 (actual)
- First posted
- 18 Oct 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Longitudinal, prospective, interventional study
| Arm | Type | Receives |
|---|---|---|
| isCGM and Physical exercise tracker | Experimental | Device: isCGM (intermittently scanned Continuous Glucose Monitoring), Device: Physical exercise trackerParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Patients > 18 years with Type 1 Diabetes:
- 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.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| isCGM (intermittently scanned Continuous Glucose Monitoring)Data collection | Device | isCGM and Physical exercise tracker |
| Physical exercise trackerData collection | Device | isCGM and Physical exercise tracker |
Primary outcome
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).
12 secondary outcomes
Sensitivity (SE) and specificity (SP) to predict Level 2 hypoglycemia
Time frame: 90 days
Predicted HbA1c from the sensor data
Time frame: 90 days
standard deviation (SD)
Time frame: 90 days
Mean glucose
Time frame: 90 days
Level 3 hypoglycaemia
Time frame: 90 days
Percentage of time in hypoglycemic ranges
Time frame: 90 days
Percentage of time in target range
Time frame: 90 days
Percentage of time in hyperglycemic range >180
Time frame: 90 days
Percentage of time in hyperglycemic range >250
Time frame: 90 days
Glucose variability LBGI
Time frame: 90 days
Glucose variability HBGI
Time frame: 90 days
Number of Level 3: severe hypoglycemia
Time frame: 90 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ignacio Conget, MD, PhD principal investigator
Hospital Clinic of Barcelona
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing isCGM (intermittently scanned Continuous Glucose Monitoring) and Physical exercise tracker in people with Type1diabetes and Hypoglycemia, run by Hospital Clinic of Barcelona at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensitivity (SE) and specificity (SP) to predict Level 1 hypoglycemia (time frame: 90 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2019.