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Electrocardiographic Modifications and Spontaneous Hypoglycemic Episodes in Type 1 Diabetes

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ClinicalTrials.gov Identifier: NCT03682250
Recruitment Status : Recruiting
First Posted : September 24, 2018
Last Update Posted : September 24, 2018
Sponsor:
Information provided by (Responsible Party):
Rémi Rabasa-Lhoret, Institut de Recherches Cliniques de Montreal

Tracking Information
First Submitted Date September 21, 2018
First Posted Date September 24, 2018
Last Update Posted Date September 24, 2018
Actual Study Start Date September 17, 2018
Estimated Primary Completion Date December 31, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: September 21, 2018)
QT intervals corrected for heart rate [ Time Frame: 48 hours ]
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures
 (submitted: September 21, 2018)
  • Percentage of time between 4.0 and 10.0 mmol/L [ Time Frame: 48 hours ]
  • Percentage of time below 3.5 mmol/L [ Time Frame: 48 hours ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Electrocardiographic Modifications and Spontaneous Hypoglycemic Episodes in Type 1 Diabetes
Official Title Electrocardiographic Modifications During Spontaneous Hypoglycemic Episodes in Patients With Type 1 Diabetes at High Cardiovascular Risk
Brief Summary The population of type 1 diabetes patients with cardiovascular disease is increasing and this study aims to explore the electrocardiographic changes that are associated with spontaneous hypoglycemia in this type of population. More precisely, this study will investigate if these modifications are of the same nature as those already observed in different populations (patients with type 2 diabetes) to see the pro-arrhythmogenic impact of hypoglycemia in patients with type 1 diabetes.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Other
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population Individuals with type 1 diabetes presenting a high cardiovascular risk
Condition Type 1 Diabetes Mellitus
Intervention
  • Device: FreeStyle Libre Pro
    A FreeStyle Libre Pro will be used to identify hypoglycemic episodes
  • Device: Holter monitor
    A Holter monitor will be used to measure heart's activity
Study Groups/Cohorts Patients with type 1 diabetes with a high cardiovascular risk
Interventions:
  • Device: FreeStyle Libre Pro
  • Device: Holter monitor
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: September 21, 2018)
59
Original Estimated Enrollment Same as current
Estimated Study Completion Date December 31, 2020
Estimated Primary Completion Date December 31, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Men and women ≥ 18 years old;
  • Be able to give informed consent;
  • Diagnosis of type 1 diabetes for ≥ 6 months;
  • Treated with intensive insulin therapy (multiple injections of insulin or insulin pump)

AND EITHER

  • A history of CV disease defined as: 1) Established diagnosis of atherosclerotic coronary artery disease (example: previous history of infarction); 2) Previous cerebral Vascular Stroke or Transient Ischemic Accident; 3) Anterior revascularization of the coronary arteries, carotid artery or peripheral arteries; 4) At least one coronary stenosis, carotid artery or lower extremity arteries > 50%; 5) History of symptomatic coronary heart disease confirmed with hospitalization or a positive stress test result or by any cardiac imaging result, or unstable angina with changes observed at the ECG; 6) Asymptomatic cardiac ischemia confirmed by a nuclear imaging test, an exercise test, a dobutamine stress echo; 7) NYHA II-III class chronic heart failure; 8) Amputation of limb or foot due to circulatory insufficiency.
  • Or more than 30 years duration of T1D and at least 2 of the following risk factors or associated condition: 1) Chronic renal failure eGFR <60 ml / min / 1.73 m2); 2) Presence of micro or macro-albuminuria (albumin / creatinine ratio > 2); 3) Hypertension or treatment for hypertension; 4) Hyperlipidemia or treatment for hypolipemia; 5) Abdominal obesity (Waist circumference> 94 cm for men and > 80 cm for women); 6) Smoking ; 7) Significant retinopathy (pre-proliferative, proliferating, laser or intravitreous injection); 8) Body mass index > 30 kg /m2; 9) Erectile dysfunction; 10) Left ventricular hypertrophy; 11) Positive family history of early MCAS (H < 55 years old and F < 65 years old)

Exclusion Criteria:

  • Definitive criteria: 1) QRS > 120 ms on the baseline ECG; 2) Presence of atrial fibrillation at inclusion; 3) Current intake of any drug that may prolong QT according to the judgment of the investigator and the update of the list available on www.professionsante.com.
  • Transient criteria (the patient can be included once the anomaly is corrected): 1) Hypokalemia (< 3.5 mmol/L); 2) Hypocalcemia (ionized calcium < 1.10 mmol/L); 3) Hypomagnesemia (< 0.7 mmol/L)
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Remi Rabasa-Lhoret 1-514-987-5666 remi.rabasa-lhoret@ircm.qc.ca
Contact: Helene Mansaray 1-514-987-5500 ext 3227 mansarayh@yahoo.fr
Listed Location Countries Canada
Removed Location Countries  
 
Administrative Information
NCT Number NCT03682250
Other Study ID Numbers FRYPOT
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Rémi Rabasa-Lhoret, Institut de Recherches Cliniques de Montreal
Study Sponsor Institut de Recherches Cliniques de Montreal
Collaborators Not Provided
Investigators
Principal Investigator: Remi Rabasa-Lhoret Institut de recherches cliniques de Montréal
PRS Account Institut de Recherches Cliniques de Montreal
Verification Date September 2018