Hypoglycemia Prevention and Awareness Program

NCT06775288 | Active Not Recruiting

• 1 other identifier: DokuzEU-IHH-MD-01
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this project is to examine the effects of the Hypoglycemia Prevention and Awareness Program (HypoPAP) on patient outcomes, including metabolic, psychological, social, and economic parameters, in individuals with type 2 diabetes and impaired hypoglycemia awareness. Through the interventions provided to participants, the study aims to achieve the following improvements:

• Physiological parameters: Enhanced glycemic control, reduced hypoglycemia frequency, improved hypoglycemia awareness, and optimized HbA1c levels.
• Psychological parameters: Reduced fear of hypoglycemia, increased hypoglycemic confidence, and improved attitudes toward hypoglycemia management.
• Social parameters: Decreased social withdrawal due to fear of hypoglycemia, as assessed through relevant items in validated scales.
• Economic parameters: Reduced frequency of hospitalizations and emergency department visits. Overall, the program seeks to enhance participants' ability to prevent and manage hypoglycemia, thereby improving their overall well-being.

Conditions

Diabetes; Hypocalcemia; Telehealth; Nursing Care; Nursing Education

Keywords

hypoglycemia awareness; , telehealth; hypoglycemia; type 2 diabetes; nursing care

Outcome Measures

Primary Outcomes (4)

• Hypoglycemic Confidence Scale

  The Hypoglycemic Confidence Scale is a nine-item self-report scale developed by William Polonsky and colleagues in 2017 that examines the degree to which diabetic patients feel safe and comfortable about their ability to protect themselves from hypoglycemia-related problems. It was developed for use in adults with diabetes (Type 1 and Type 2 using insulin). The Hypoglycemic Confidence Scale focuses on three areas: 1. Self-confidence (e.g., confidence in recognizing and managing hypoglycemia before blood sugar drops too low) 2. Confidence in avoiding hypoglycemia at critical times (e.g., while driving, exercising, and sleeping) 3. An estimate of the confidence of the spouse/partner. The Hypoglycemic Confidence Scale items are scored between 1 and 4 (1; Not at all confident 2; Somewhat confident 3; Moderately confident 4; Very confident). The ninth scale item for diabetic individuals with a spouse was interpreted as: 1; Not at all confident 2; Somewhat confident 3; Moderately confident

  1 month

• Hypoglycemia Fear Scale

  The Hypoglycemia Fear Survey-HFS, was used to determine the fear of hypoglycemia in diabetic individuals. This scale consists of two subgroups, behavior and anxiety, and a total of 33 items. The behavior subgroup of this scale consists of 15 items. In the behavior subgroup; diabetic individuals are asked questions about what they have done in their daily lives to prevent their blood glucose levels from falling in the last 6 months. The anxiety subgroup consists of 18 items, and individuals are asked how often they have worried about the items given due to low blood glucose levels in the last 6 months. The answers vary between; "0 points: never; 1 point: rarely; 2 points: sometimes; 3 points often; 4 points: always". A high score indicates a high fear of hypoglycemia.

  1 month

• Hypoglycemia Attitude and Behavior Scale

  This scale was prepared for individuals with type 2 diabetes and consists of 14 items. It aims to measure hypoglycemia attitudes and behaviors of individuals with type 2 diabetes in three sub-dimensions: Avoidance (four items), confidence (five items) and anxiety (five items). Anxiety questions individuals' concerns about hypoglycemia. Avoidance questions the attitudes and behaviors adopted to avoid hypoglycemia. Confidence consists of questions aimed at determining the degree of comfort provided by not experiencing problems caused by hypoglycemia. The scale does not have a total score: While the avoidance and anxiety sub-dimensions are scored directly (1 = Strongly disagree, 5 = Strongly agree), the Confidence sub-dimension is scored inversely (1 = Strongly agree, 5 = Strongly disagree).

  1 month

• Hypoglycemia Awareness Questionnaire

  The Hypoglycemia Awareness Questionnaire includes questions that evaluate the hypoglycemia awareness of the individuals participating in the study, how often they experience hypoglycemia, the symptoms they experience during hypoglycemia, and how they intervene when these symptoms occur. In the study, the responses of individuals to the question "Can you feel low blood sugar?" are evaluated. Individuals are required to select one of the following responses: "always," "usually," "sometimes," or "never." Patients who only respond "always" are considered to have normal symptomatic awareness of hypoglycemia; those who respond "usually" are defined as having reduced hypoglycemia awareness, and those who respond "sometimes and never" are defined as having no hypoglycemia awareness. The questionnaire is one of the most frequently used assessment questionnaires in the literature for hypoglycemia awareness .

  1 month

Study Arms (2)

Experimental Group

EXPERIMENTAL

3 months Hypoglycemia Prevention and Awareness Program

Other: Hypoglycemia prevention and awareness program (HypoPAP)

Control Group

NO INTERVENTION

3 months follow-up

Interventions

Hypoglycemia prevention and awareness program (HypoPAP) OTHER

Online hypoglycemia prevention and awareness training Supporting the prevention of hypoglycemia with the use of evidence-based diabetes-friendly plates Encouraging physical activity and supporting glycemic control with a pedometer Filling in a weekly problem-solving notebook Conducting weekly online problem-solving meetings Online counseling service when needed

Experimental Group

Eligibility Criteria

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

You may qualify if:

• Being 18 years of age and older
• Being able to communicate in Turkish
• Being diagnosed with type 2 diabetes
• Having used insulin for at least one year
• Having reduced hypoglycemia awareness
• Being willing to participate in the study
• Having and being able to use information technology products (telephone, computer).

You may not qualify if:

• Having visual, auditory, cognitive impairment
• Having a condition that prevents communication
• Not being able to use information technology products
• Having chronic renal failure, chronic vascular disease, chronic liver disease, cancer
• Pregnancy
• Endocrine and eating disorders
• Individuals who do not agree to participate in the study

Sponsors & Collaborators

• Merve DerviAYoAYlu: lead
• The Scientific and Technological Research Council of Turkey: collaborator

Study Sites (1)

Dokuz Eylül University

Izmir, 35640, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Diabetes Mellitus; Hypocalcemia; Hypoglycemia; Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Calcium Metabolism Disorders; Water-Electrolyte Imbalance

Study Officials

• Merve M Dervişoğlu, MSc

  Dokuz Eylul University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Research Assistant

Model Details: randomized controlled trial

Study Record Dates

• First Submitted: January 4, 2025
• First Posted: January 15, 2025
• Study Start: November 1, 2024
• Primary Completion: December 15, 2024
• Study Completion: April 15, 2025
• Last Updated: January 15, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)