The Influence of Personality Characteristics and Emotions on Blood Glucose Levels Among Type 1 Diabetes Mellitus Patients

NCT04978441 | Completed

• 1 other identifier: 0436-19-TLV
• Study Type: observational
• Target: 75
• Locations: 1 country
• Sites: 1

Brief Summary

The research goal is to find a correlation between patient personality characteristics, patients' mood and glycemic control. Eventually, using this information may allow treating physicians the ability to better balance glucose blood levels in patients with T1DM, by recognizing influencing psychological parameters. The conclusion from this research will add to other physiological parameters that are being studied today, and in the future will be integrated into an artificial pancreas. The investigators believe that there is a correlation that hasn't been studied in the past between personality characteristics, daily emotions and the ability to balance glucose blood levels in patients with T1DM.

Conditions

Diabetes Mellitus, Type 1; Emotions; Personality; Sleep

Outcome Measures

Primary Outcomes (1)

• correlation between baseline personality characteristics, changing emotions throughout the day, and glycemic levels in patients with T1DM

  correlation between patient personality characteristics, patients' mood and glycemic control. Eventually, using this information may allow us the ability to better balance glucose blood levels in patients with T1DM, by recognizing influencing psychological parameters

  through study completion, an average of 1 year

Study Arms (1)

Type 1 diabetes mellitus (T1DM)

1. Males or females above 18 years old 2. Patients with a prior medical history diagnosis of T1DM 3. Patients who are using a continuous glucose monitor (CGM or FGM)

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with a type 1 Diabetes Mellitus diagnosis

You may qualify if:

• Males or females above 18 years old
• Patients with a prior medical history diagnosis of T1DM
• Patients who are using a continuous glucose monitor (CGM or FGM)

You may not qualify if:

• Patients without a diagnosis of type 1 DM
• patients who are not using a continuous glucose monitor (CGM or FGM)
• patients who did not sign an informed consent
• lack of judgment and underage populations
• Patients without a mobile smart device (smart phone)

Sponsors & Collaborators

• Tel-Aviv Sourasky Medical Center: lead
• Rambam Health Care Campus: collaborator
• Tel Aviv University: collaborator

Study Sites (1)

The Institute of Endocrinology Metabolism and Hypertension

Tel Aviv, 64239, Israel

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

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

Study Officials

• Gon Shoham, MD

  Tel Aviv University

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 2, 2021
• First Posted: July 27, 2021
• Study Start: February 17, 2020
• Primary Completion: November 30, 2020
• Study Completion: March 1, 2021
• Last Updated: August 9, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1)