Electrocardiographic Modifications and Spontaneous Hypoglycemic Episodes in Type 1 Diabetes

• ClinicalTrials.gov Identifier: NCT03682250
• Recruitment Status: Active, not recruiting
• First Posted: September 24, 2018
• Last Update Posted: March 8, 2022
• Sponsor: Institut de Recherches Cliniques de Montreal
• Information provided by (Responsible Party): Rémi Rabasa-Lhoret, Institut de Recherches Cliniques de Montreal

Study Description

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.

Condition or disease	Intervention/treatment
Type 1 Diabetes Mellitus	Device: FreeStyle Libre Pro; Device: Holter monitor

Study Design

• Study Type: Observational
• Actual Enrollment: 29 participants
• Observational Model: Other
• Time Perspective: Prospective
• Official Title: Electrocardiographic Modifications During Spontaneous Hypoglycemic Episodes in Patients With Type 1 Diabetes at High Cardiovascular Risk
• Actual Study Start Date: September 17, 2018
• Estimated Primary Completion Date: June 30, 2022
• Estimated Study Completion Date: August 31, 2022

Groups and Cohorts

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

Outcome Measures

Primary Outcome Measures :

1. QT intervals corrected for heart rate [ Time Frame: 48 hours ]

Secondary Outcome Measures :

1. Percentage of time between 4.0 and 10.0 mmol/L [ Time Frame: 48 hours ]
2. Percentage of time below 3.5 mmol/L [ Time Frame: 48 hours ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No
• Sampling Method: Probability Sample

Study Population

Individuals with type 1 diabetes presenting a high cardiovascular risk

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 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)

Contacts and Locations

Locations

Canada, Quebec

Institut de recherches cliniques de Montréal

Montreal, Quebec, Canada, H2W 1R7

Sponsors and Collaborators

Institut de Recherches Cliniques de Montreal

Investigators

• Principal Investigator: Remi Rabasa-Lhoret; Institut de recherches cliniques de Montréal

More Information

• Responsible Party: Rémi Rabasa-Lhoret, Full professor, Institut de Recherches Cliniques de Montreal
• ClinicalTrials.gov Identifier: NCT03682250
• Other Study ID Numbers: FRYPOT
• First Posted: September 24, 2018
• Last Update Posted: March 8, 2022
• Last Verified: March 2022

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Diabetes Mellitus; Diabetes Mellitus, Type 1; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases