Clinical trial NCT06767865: Online Diabetes Clinic Support Program
Official title: Online Diabetes Clinic Support Program for Type 2 Diabetic Individuals New to Insulin Therapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Endocrine System Diseases
Education
Nursing Education
Keywords: Insulin therapy
online clinic
continuous support and follow-up
type 2 diabetes
Lead sponsor: Dokuz Eylul University
Sponsor class: OTHER
Collaborators: name: The Scientific and Technological Research Council of Turkey
First posted: 2025-01-10
Enrollment: 67
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Individuals in the experimental group received online training and were subsequently provided with continuous follow-up, counseling, motivation and informative message support for three months. In addition, patients were given a target board containing a daily diabetes management program and were asked to use it for three months.
Primary purpose: SUPPORTIVE_CARE

Brief summary: This study highlights the potential of online diabetes clinic support programs in improving treatment adherence, reducing treatment-related anxiety, and enhancing self-management skills in insulin therapy. Telehealth interventions play a crucial role in optimizing diabetes care and supporting patients in managing their insulin treatment effectively.

Detailed description: This study was conducted to examine the effects of the online diabetes polyclinic continuous support program applied to individuals with type 2 diabetes who had just started insulin treatment on patient outcomes (metabolic, psychological and social parameters). The study was designed as a randomized controlled trial. It was conducted with 35 individuals in the experimental group who had just started insulin treatment and 32 individuals in the control group. Individuals were assessed with the individual diagnosis form, hypoglycemic confidence scale, hypoglycemia fear scale, diabetes empowerment scale short form, psychological insulin resistance scale, insulin treatment evaluation scale, perceived social support scale and diabetes history (treatment changes, HbA1c, lipid levels, frequency of hypoglycemia and hyperglycemia, frequency of emergency and hospital visits) before the intervention and in the 3rd and 6th months after the intervention. Individuals in the experimental group received online training and were subsequently provided with continuous follow-up, counseling, motivation and information-providing message support for three months. In addition, patients were given a target board containing a daily diabetes management program and were asked to use it for three months. As a result, it was determined that the online polyclinic service reduced the frequency of hypoglycemia and hyperglycemia in individuals who had just started insulin treatment and reduced emergency room visits (p\<0.001). It was determined that it caused a significant decrease in the HbA1c and lipid levels of the patients in the experimental group and contributed to the cessation of insulin treatment under the supervision of a physician. It was determined that the online diabetes polyclinic continuous support program was effective in reducing hypoglycemia fear and psychological insulin resistance, and increased hypoglycemic confidence and empowerment levels (p\<0.001). The study showed the potential of the online diabetes polyclinic continuous support initiative in improving the treatment process in patients who had just started insulin. These results reveal that online support systems can be effective in increasing patients' compliance with treatment and in better managing the treatment process. Online support has been shown to improve adherence to insulin therapy by providing patients with faster access to information, reduced anxiety about treatment, and greater self-management skills. This suggests that telehealth and online support programs may play an important role in diabetes management and insulin therapy acceptance.

Eligibility criteria: Inclusion Criteria:

* Individuals aged 18 and over,
* able to communicate in Turkish,
* diagnosed with type 2 diabetes,
* newly started insulin treatment,
* having and using information technology products (telephone, computer)
* willing to participate in the study voluntarily were included in the study.

Exclusion Criteria:

* Individuals with visual,
* auditory or cognitive impairments,
* a condition that prevents communication,
* cannot use information technology products,
* individuals who do not meet the inclusion criteria
* those who do not agree to participate in the study were not included.

Primary outcomes:
measure: Hypoglycemic Confidence Scale
timeFrame: 1 month
measure: Hypoglycemia Fear Survey (HFS):
timeFrame: 1 month
measure: Diabetes Empowerment Scale (DES-Short Form):
timeFrame: 1 month
measure: Psychological Insulin Resistance Scale (PIRS)
timeFrame: 1 month
measure: Insulin Therapy Assessment Scale (ITAS)
timeFrame: 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: Izmir
country: Turkey
facility: Dokuz Eylül University
state: Alsancak
Study officials:
affiliation: Dokuz Eylul University
name: Dilek D Büyükkaya Besen, PhD
role: PRINCIPAL_INVESTIGATOR
References: