Clinical trial NCT06775288: Hypoglycemia Prevention and Awareness Program
Official title: Effect of Hypoglycemia Prevention and Awareness Program (HypoPAP) on Patient Outcomes: Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Diabetes
Hypocalcemia
Telehealth
Nursing Care
Nursing Education
Keywords: hypoglycemia awareness
, telehealth
hypoglycemia
type 2 diabetes
nursing care
Lead sponsor: Dokuz Eylul University
Sponsor class: OTHER
Collaborators: name: The Scientific and Technological Research Council of Turkey
First posted: 2025-01-15
Enrollment: 62
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: randomized controlled trial
Primary purpose: SUPPORTIVE_CARE

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.

Detailed description: Optimal diabetes management is a delicate balance between treating hyperglycemia and avoiding the risk of sudden hypoglycemia. Hypoglycemia is a common, recurring, feared, and neglected complication among endocrine emergencies in individuals with diabetes. Intensive glycemic control is very important in preventing microvascular and macrovascular complications of diabetes. However, hypoglycemia is a significant obstacle to effective treatment. Individuals with diabetes experience many chronic microvascular and macrovascular complications. The most challenging and frightening complication for individuals with diabetes and their families is hypoglycemia. Diabetics are afraid of experiencing hypoglycemia, and fear of hypoglycemia is a significant obstacle to achieving normoglycemia. Hypoglycemia in individuals with type 2 diabetes often occurs due to errors in self-management. Hypoglycemia limits the physical activities and daily living activities of individuals with diabetes. Hypoglycemia, which negatively affects the physiological and psychological health of individuals with diabetes, also reduces the quality of life of patients and their families. Hypoglycemia is also the most important limitation of diabetes treatment. As the severity of hypoglycemia increases, the quality of life of patients decreases. Approximately 25% of patients with type 2 diabetes treated with insulin for more than five years experience severe hypoglycemia. Impaired awareness of hypoglycemia is the weakening of the ability to perceive warning signs during hypoglycemia. Impaired awareness of hypoglycemia is associated with a 6- to 9-fold increase in the risk of severe hypoglycemia. Recurrent hypoglycemia, defined as the occurrence of more than one hypoglycemic event, increases the risk of severe hypoglycemia, and this also reduces hypoglycemia awareness. Before implementing strategies to help increase hypoglycemia awareness in individuals with diabetes, it is important to identify individuals who are at risk for severe hypoglycemia or have decreased hypoglycemia awareness. The risk of severe hypoglycemia is highest in individuals who have had a severe hypoglycemic episode in the past or in patients with reduced awareness of hypoglycemia. Comprehensive interventions need to be developed to increase hypoglycemia awareness in diabetic patients. While structured and comprehensive hypoglycemia awareness training is limited even for individuals with type 1 diabetes in the literature, there is no training program specifically developed for type 2 diabetes. In line with this information, it is necessary to develop a structured training program for individuals with type 2 diabetes and reduced hypoglycemia awareness and evaluate its effectiveness. Therefore, the aim of this study is to examine the effect of the hypoglycemia prevention and awareness program (HypoPAP) on patient outcomes in individuals with type 2 diabetes with decreased hypoglycemia awareness. The study was planned as a randomized controlled study.

Eligibility criteria: Inclusion Criteria:

* 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).

Exclusion Criteria:

* 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
* Do not meet the inclusion criteria will not be included.

Primary outcomes:
measure: Hypoglycemic Confidence Scale
timeFrame: 1 month
measure: Hypoglycemia Fear Scale
timeFrame: 1 month
measure: Hypoglycemia Attitude and Behavior Scale
timeFrame: 1 month
measure: Hypoglycemia Awareness Questionnaire
timeFrame: 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: İzmir
country: Turkey
facility: Dokuz Eylül University
Study officials:
affiliation: Dokuz Eylul University
name: Merve M Dervişoğlu, MSc
role: PRINCIPAL_INVESTIGATOR
References: