Electrocardiographic Modifications and Spontaneous Hypoglycemic Episodes in Type 1 Diabetes

NCT03682250 | Terminated

• 1 other identifier: FRYPOT
• Study Type: observational
• Target: 29
• Locations: 1 country
• Sites: 1

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.

Conditions

Type 1 Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

• QT intervals corrected for heart rate

  48 hours

Secondary Outcomes (2)

• Percentage of time between 4.0 and 10.0 mmol/L

  48 hours

• Percentage of time below 3.5 mmol/L

  48 hours

Study Arms (1)

Patients with type 1 diabetes with a high cardiovascular risk

Device: FreeStyle Libre Pro; Device: Holter monitor

Interventions

FreeStyle Libre Pro DEVICE

A FreeStyle Libre Pro will be used to identify hypoglycemic episodes

Patients with type 1 diabetes with a high cardiovascular risk

Holter monitor DEVICE

A Holter monitor will be used to measure heart's activity

Patients with type 1 diabetes with a high cardiovascular risk

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Individuals with type 1 diabetes presenting a high cardiovascular risk

You may qualify if:

• 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)

You may not qualify if:

• 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)

Sponsors & Collaborators

• Institut de Recherches Cliniques de Montreal: lead

Study Sites (1)

Institut de recherches cliniques de Montréal

Montreal, Quebec, H2W 1R7, Canada

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Interventions

Electrocardiography, Ambulatory

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Electrocardiography; Heart Function Tests; Diagnostic Techniques, Cardiovascular; Diagnostic Techniques and Procedures; Diagnosis; Electrodiagnosis; Monitoring, Ambulatory; Monitoring, Physiologic

Study Officials

• Remi Rabasa-Lhoret

  Institut de recherches cliniques de Montréal

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Full professor

Study Record Dates

• First Submitted: September 21, 2018
• First Posted: September 24, 2018
• Study Start: September 17, 2018
• Primary Completion: December 31, 2021
• Study Completion: April 5, 2024
• Last Updated: February 25, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)