Online Diabetes Clinic Support Program

January 5, 2025 updated by: Dilek Büyükkaya Besen

Online Diabetes Clinic Support Program for Type 2 Diabetic Individuals New to Insulin Therapy

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
67

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
    • Alsancak
      • Izmir, Alsancak, Turkey, 35000
        • Dokuz Eylul University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Experimental Group
intervention+ Follow-up at 0-3-6 months
Other: online support programe
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.
No Intervention: Control Group
Follow-up at 0-3-6 months

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Hypoglycemic Confidence Scale
Time Frame: 1 month
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 confident and comfortable about their ability to avoid hypoglycemia-related problems. It was developed for use in adults with diabetes (Type 1 and Type 2 who use 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. Estimation of spouse/partner's confidence. The Hypoglycemic Confidence Scale items are scored between 1-4 (1; Not at all confident 2; Somewhat confident 3; Moderately confident 4; Very confident). The ninth scale item for diabetic individuals with a spouse is interpreted as: 1; Not at all confident 2; Somewhat confident 3; Moderately confident 4; Very confident.
1 month
Hypoglycemia Fear Survey (HFS):
Time Frame: 1 month
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 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 the decrease in their blood glucose levels in the last 6 months. The answers range from; "0 points: never; 1 point: rarely; 2 points: sometimes; 3 points often; 4 points: always". The high score obtained indicates that the fear of hypoglycemia is high. The Turkish validity and reliability were made by Özgül Erol.
1 month
Diabetes Empowerment Scale (DES-Short Form):
Time Frame: 1 month
The validity and reliability of the scale were made in 2020. DES-SF was designed to assess the empowerment levels of individuals regarding their health status. The scale is a five-point Likert type and has eight items (scored between "Strongly disagree" = 1 and "Strongly agree = 5"). The scale does not have a cut-off score. The scale is calculated based on the average score. An increase in the average score indicates an increase in the empowerment level.
1 month
Psychological Insulin Resistance Scale (PIRS)
Time Frame: 1 month
The scale was developed by Song and colleagues in 2016. The scale, which is a 5-point Likert type (1: strongly agree, 2: agree, 3: undecided, 4: disagree, 5: strongly disagree), consists of 18 items and 2 sub-dimensions (Supportive factor and Psycho-cognitive/physical factor). The total score of the scale varies between 18-90. A high score obtained from the scale indicates that the patient's psychological resistance to insulin use is high. The scale was developed by Işık and Colleagues in 2021. As a result of the Turkish validity and reliability analysis, the scale consists of 12 items and 3 sub-dimensions (supportive, psycho-cognitive, physical factors). Cronbach's alpha coefficient was determined as 0.82.
1 month
Insulin Therapy Assessment Scale (ITAS)
Time Frame: 1 month
The scale was developed by Sürücü et al. in 2017. Number of sub-dimensions and items: It consists of two sub-dimensions and a total of 20 items. Positive attitude (4 items): Items 3, 8, 17 and 19; Negative attitude (16 items): Items 1, 2, 4, 5, 6, 7, 9, 10, 11, 12, 13, 14, 15, 16, 18 and 20. Scale items are rated on a Likert type scale between "strongly disagree" and "strongly agree" and 5 points. The sum of four positively worded items (4-20) gives the positive evaluation sub-dimension, and the sum of 16 negatively worded items (16-80) gives the negative evaluation sub-dimension. The sum of the items (20 items) gives the total score (20-100). The scale total score is found by reversing the four positively worded items and summing them with the other 16 negatively worded items.
1 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Dilek Büyükkaya Besen

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
The Scientific and Technological Research Council of Turkey

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Dilek D Büyükkaya Besen, PhD, Dokuz Eylul University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 1, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 1, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 30, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 5, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 25, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 5, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • DokuzEU-IHH-DBB-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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