Electrocardiographic Modifications and Spontaneous Hypoglycemic Episodes in Type 1 Diabetes

Electrocardiographic Modifications During Spontaneous Hypoglycemic Episodes in Patients with Type 1 Diabetes At High Cardiovascular Risk

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.

Study Overview

• Status: Terminated
• Conditions: Type 1 Diabetes Mellitus
• Intervention / Treatment: Device: FreeStyle Libre Pro; Device: Holter monitor

• Study Type: Observational
• Enrollment (Actual): 29

Contacts and Locations

Study Locations

• Canada
  • Quebec
    • Montreal, Quebec, Canada, H2W 1R7
      • Institut de recherches cliniques de Montreal

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Individuals with type 1 diabetes presenting a high cardiovascular risk

Description

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 20 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)

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patients with type 1 diabetes with a high cardiovascular risk	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
QT intervals corrected for heart rate	48 hours

Secondary Outcome Measures

Outcome Measure	Time Frame
Percentage of time between 4.0 and 10.0 mmol/L	48 hours
Percentage of time below 3.5 mmol/L	48 hours

Collaborators and Investigators

• Sponsor: Institut de Recherches Cliniques de Montreal
• Investigators: Principal Investigator: Rémi Rabasa-Lhoret, Institut de recherches cliniques de Montreal

Study record dates

Study Major Dates

• Study Start (Actual): September 17, 2018
• Primary Completion (Actual): December 31, 2021
• Study Completion (Actual): April 5, 2024

Study Registration Dates

• First Submitted: September 21, 2018
• First Submitted That Met QC Criteria: September 21, 2018
• First Posted (Actual): September 24, 2018

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 24, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Endocrine System Diseases; Metabolic Diseases; Autoimmune Diseases; Immune System Diseases; Glucose Metabolism Disorders; Diabetes Mellitus; Diabetes Mellitus, Type 1
• Other Study ID Numbers: FRYPOT

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• 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