Efficacy of Nurse-Led WIKAP Intervention on Hypoglycemia Coping Confidence and Outcomes in Adolescents with Type 1 Diabetes Mellitus: A Quasi-Experimental Study in Zhijiang, China

Introduction

Type 1 diabetes mellitus (T1DM) is a chronic autoimmune disorder characterized by the destruction of pancreatic beta cells, leading to absolute insulin deficiency and lifelong dependence on exogenous insulin. The global incidence of T1DM among children and adolescents has been steadily increasing.¹ In 2021, approximately 1.5 million individuals under the age of 20 worldwide were diagnosed with T1D.² In China, this trend is particularly pronounced; the “Chinese Diabetes Prevention and Control Guidelines (2024 Edition)” reports a near fourfold increase in T1DM incidence among individuals under 15 years over the past two decades, positioning China as the fourth highest globally in terms of affected children and adolescents.³ Recent epidemiological data from China report approximately 68,816 cases of T1DM in children in 2021, with 10,559 new diagnoses.⁴ This growth trend is expected to continue over the next 15 years.⁵

Adolescents with T1DM face a heightened risk of hypoglycemia, a common and potentially life-threatening complication arising from insulin therapy mismatches with glucose levels.⁶ Mild (grade 1) hypoglycemic episodes occur frequently,⁷ often multiple times per week, while severe events contribute significantly to morbidity and mortality.⁸ Studies estimate that hypoglycemia accounts for 4–10% of deaths in children and adolescents with T1DM, with rates as high as 6.9 deaths per 1,000 person-years in affected individuals.⁹ Adolescents with T1DM encounter unique challenges in disease management, including developmental behaviors such as insulin restriction for weight control, fluctuating family dynamics, perceived social pressures, and negative coping strategies that foster pessimistic attitudes toward their condition.¹⁰ These barriers often exacerbate fear of hypoglycemia and impair hypoglycemic confidence (HC),¹¹ defined as an individual’s perceived ability to safely manage and avoid hypoglycemia,¹² which is essential for mitigating adverse outcomes and improving quality of life.¹³ However, existing interventions for hypoglycemia management in adolescents with T1DM often focus primarily on glycemic control and education, with limited emphasis on improving hypoglycemic confidence and related behavioral and psychological factors.

The web-based Information-Knowledge-Attitude-Practice (WIKAP) model serves as a structured health education framework that promotes personalized interventions by healthcare professionals to address patients’ specific needs, encouraging active participation in self-management and enhancing coping confidence.¹⁴ Importantly, the WIKAP framework aligns closely with the multidimensional nature of hypoglycemic confidence, as it targets not only knowledge acquisition but also cognitive and behavioral components, including risk perception, emotional responses, and self-management skills. By systematically improving patients’ understanding (Information/Knowledge), reshaping attitudes toward hypoglycemia (Attitude), and reinforcing appropriate self-care behaviors (Practice), WIKAP may provide a comprehensive approach to addressing the psychological and behavioral barriers underlying low hypoglycemic confidence. This relational nursing approach has demonstrated efficacy in managing various chronic diseases, including systemic lupus erythematosus, chronic obstructive pulmonary disease, cerebrovascular disease, Alzheimer’s disease, and gastric cancer, by improving health literacy, attitudes, and behaviors.^15–18 Despite its success in these contexts, the WIKAP model has not been applied to hypoglycemia management in adolescent T1DM. Therefore, its application in this context is theoretically justified but remains empirically underexplored, highlighting the need for targeted investigation. Additionally, the WIKAP model provides a structured and patient-centered framework for nursing practice, enabling nurses to deliver more targeted, continuous, and individualized education and support, thereby enhancing the quality and effectiveness of diabetes care.

In pediatric T1DM management, primary caregivers play a critical role in daily glycemic control, including insulin administration, dietary regulation, and monitoring for hypoglycemic events. Adolescents often rely on caregivers for support in recognizing and managing hypoglycemia, particularly in complex or emergency situations. Caregivers’ knowledge, confidence, and psychological responses can directly influence adolescents’ self-management behaviors and health outcomes. Moreover, caregiver satisfaction and engagement are increasingly recognized as important indicators of intervention effectiveness, as they are closely associated with adherence, continuity of care, and overall treatment success. Despite this, many interventions primarily focus on patients while overlooking the integral role of caregivers. Therefore, incorporating caregiver-related outcomes is essential to provide a more comprehensive evaluation of diabetes management strategies.

With the rapid advancement of internet technology, web-based interventions have become increasingly feasible for continuous patient-provider communication, offering scalable tools to support diabetes self-management.^19–21 However, evidence on WIKAP models specifically targeting HC in adolescent T1DM remains limited. Therefore, this study investigates the impact of a nurse-led WIKAP on hypoglycemic confidence among adolescents with T1DM, while also considering caregiver-related outcomes, aiming to provide empirical evidence for enhancing diabetes care through technology-integrated behavioral strategies.

Materials and Methods

Study Design

This prospective, non-concurrent controlled trial was conducted in the endocrinology department of a tertiary hospital in Zhijiang City, China. The department serves approximately 400 pediatric and adolescent patients with T1DM annually. It is staffed by 8 senior endocrinologists, 6 certified diabetes educators, and a specialized nursing team. Services provided include continuous glucose monitoring (CGM) training, insulin pump therapy, and comprehensive diabetes self-management education (DSME).

A quasi-experimental, non-randomized design was adopted to prioritize contamination control in a single-center clinical setting, where individual randomization would likely lead to treatment imitation among participants. Participants were purposively recruited from June to December 2025 to ensure a representative sample reflecting the clinical heterogeneity of adolescents with T1DM. To reduce group contamination, those enrolled from June to September 2025 formed the control group (n=55), receiving routine care, while those enrolled from October to December 2025 formed the intervention group (n=55), receiving the WIKAP model alongside routine care. Allocation was determined strictly by the period of enrollment (sequential allocation), and no randomization was applied after selection. The non-concurrent design was employed to allow sequential enrollment and control for temporal biases in outcomes.²² The trial lasted 8 weeks per participant, with assessments at baseline and follow-up. Ethical approval was granted by the Institutional Review Board of Zhijiang People’s Hospital (Approval No. ZJ2025-41). The study was conducted in accordance with the Declaration of Helsinki, and written informed consent was obtained from all participants or their legal guardians. This clinical trial was registered with the Chinese Clinical Trial Registry (registration number: ChiCTR2500104670).

Participants and Sample Size

Adolescents with T1DM were eligible if they met the following strict and objective inclusion criteria: (1) aged 10–24 years with a clinical diagnosis of T1DM; (2) history of hypoglycemic symptoms as per the American Diabetes Association (ADA) classification, defined as blood glucose <70 mg/dL (<3.9 mmol/L) for level 1 hypoglycemia; (3) adequate reading, comprehension, and communication skills; (4) awareness of their condition and willingness to provide informed consent; (5) access to an effective communication device (eg., smartphone) with parental oversight; and (6) regular use of bicycles or motor vehicles, which increases the risk of hypoglycemia during physical exertion. Exclusion criteria included: (1) cognitive impairment or psychiatric disorders; (2) severe comorbidities or T1DM complications (eg., advanced retinopathy or nephropathy); (3) withdrawal due to medical or personal reasons; (4) participation in other concurrent studies; and (5) repeated hospitalizations during the trial period. During screening, two independent researchers evaluated eligibility to minimize selection bias, with all screened individuals documented to ensure transparency.

Sample size was calculated based on prior studies of behavioral interventions in T1DM,²³ targeting a medium effect size (Cohen’s d=0.5) on hypoglycemic confidence, with 80% power and α=0.05, resulting in approximately 50 participants per group, adjusted to 58 to account for 15% attrition. Baseline imbalances between groups will be adjusted as covariates in the final analysis to ensure internal validity.

Interventions

Control Group

Participants received standard care, including health education on T1DM management (diet, medication, and hypoglycemia prevention) and psychological support with referrals if needed. Follow-up occurred weekly during hospitalization and biweekly post-discharge via WeChat.

Intervention Group (WIKAP Model)

The WIKAP intervention, adapted from the KAP framework,^24,25 utilized web-based tools for continuous nurse-led support. It consisted of three stages. Preparation Stage: A multidisciplinary team (chief nurse, two endocrinology nurses, psychological counselor, and head nurse) was formed. Baseline assessments using the Scale and a general questionnaire established personalized participant profiles. Implementation Stage: An 8-week tailored plan was developed based on WIKAP literature,^26,27 delivered hybridly (in-person during hospitalization and web-based post-discharge). The intervention details are outlined in Table 1. Final Stage: All materials (scales, images, and records) were archived by a graduate student. A dedicated WeChat group was maintained for the intervention group, with files organized chronologically for easy access.

Table 1 WIKAP Model Intervention Plan for Hoglycemia Confidence in Adolescents T1DM

Outcome Measures

Primary Outcome: Hypoglycemic Confidence

The Chinese version of the Hypoglycemia Attitudes and Behavior Scale (HABS) was used to assess anxiety, avoidance, and coping confidence related to hypoglycemia. Originally developed by Polonsky et al in 2015,²⁸ the HABS consists of 14 items-5 items measuring anxiety, 4 items measuring avoidance, and 5 items measuring coping confidence. The scale is designed to assess the level of hypoglycemia fear and concern in diabetic patients.²⁹ The Chinese version was adapted by Song in 2021,³⁰ maintaining the same structure and scoring system. The scale uses a 5-point Likert scale, with responses ranging from “Never” (1) to “Always” (5). Total scores range from 14 to 70, with higher scores indicating greater concern about hypoglycemia. The Chinese adaptation demonstrated good reliability, with a Cronbach’s α coefficient of 0.893 and a split-half reliability of 0.816, making it a valid tool for assessing hypoglycemic attitudes and behaviors in Chinese patients with T1DM.

Secondary Outcomes

Glycated Hemoglobin (HbA1c)

HbA1c levels were measured as an indicator of long-term glycemic control. Venous blood samples were collected at baseline and at the 8-week follow-up, analyzed using high-performance liquid chromatography (HPLC) in a certified central laboratory. Results were expressed as percentages, with target values aligned to age-appropriate guidelines for adolescents with T1DM (typically <7.0–7.5%).^31,32

Hypoglycemia Incidence

Hypoglycemia incidence was assessed as the frequency of events over the 8-week study period, self-reported via standardized participant diaries. Events were classified according to American Diabetes Association (ADA) guidelines: level 1 (blood glucose <70 mg/dL [<3.9 mmol/L] and ≥54 mg/dL [≥3.0 mmol/L]), level 2 (<54 mg/dL [<3.0 mmol/L]), and level 3 (severe events requiring assistance, regardless of glucose level).³³ Participants were trained to record symptoms, confirmatory blood glucose readings (via glucometer), and any interventions. Incidence rates were calculated as events per participant-week, with separate reporting for total, nocturnal, and severe episodes to capture intervention impacts on hypoglycemia burden in adolescents.

Caregiver Satisfaction

A holistic nursing satisfaction survey evaluated caregivers’ perceptions of health education format, nursing competence, and hypoglycemia prevention confidence. Responses were categorized as very satisfied, satisfied, mostly satisfied, or Unsatisfied. The survey was administered anonymously at the 8-week follow-up to primary caregivers.

Data Collection

Two specialist nurses from the gastroenterology department (independent of the intervention team) administered baseline assessments (general data, HABS, HbA1c, and initial hypoglycemia diary instructions). Follow-up evaluations (HABS, HbA1c, hypoglycemia diaries, and satisfaction survey) occurred at 8 weeks via WeChat or phone appointments, supervised by a postgraduate student during discharge transitions. All data were double entered to ensure accuracy.

Statistical Analysis

Data were analyzed using SPSS version 27.0³⁴ and R software (version 4.2.0). Normality of continuous variables was assessed via the Shapiro–Wilk test or visual inspection of histograms. Normally distributed continuous variables were presented as mean ± standard deviation. To account for the intercorrelations between psychological outcomes, a doubly multivariate repeated-measures MANOVA was first conducted using Pillai’s Trace statistic. Pre- to post-intervention changes were also evaluated through mixed-design analysis of variance (ANOVA) to examine time, group, and interaction effects. Simple effects analysis and post-hoc comparisons were performed using the emmeans package with Bonferroni correction. Ordinal variables were compared using the Mann–Whitney U-test. Categorical variables were expressed as frequencies and percentages, with between-group differences analyzed via chi-square tests or Fisher’s exact tests as appropriate. All p-values were two-sided, with statistical significance set at p < 0.05.

Results

General Characteristics of the Study

Following the 8-week intervention period, in the observation group, one participant withdrew due to changes in their medical condition, and two withdrew for personal reasons, resulting in a final inclusion of 55 cases. In the control group, three participants were lost to follow-up due to inability to establish contact, leading to a final inclusion of 55 cases (Figure 1). The detailed comparison of general data between the two groups is presented in Table 2.

Table 2 Comparison of General Data of the Two Groups (N = 110)

Figure 1 Flow diagram of participant recruitment and allocation in the study. A total of 156 individuals were invited to participate. After eligibility screening, 127 participants were enrolled in the study, and 116 were randomized equally into the WIKAP intervention group (n = 58) and the Control group (n = 58). Reasons for declining participation, ineligibility, withdrawal prior to randomization, and loss to follow-up are detailed in the diagram. The final analysis included 55 participants in each group.

Hypoglycemia Coping Outcomes Between Two Groups

Overall Multivariate Analysis

To account for the inter-correlations between the psychological dimensions (Anxiety, Avoidance, and Confidence), a doubly multivariate repeated-measures MANOVA was conducted. The analysis revealed a highly significant Group x Time interaction effect (Pillai’s Trace = 0.855, F(1, 108) = 635.45, P< 0.001, Partial η² = 0.635).(Table 3)

Table 3 Doubly Multivariate MANOVA Results for Psychological Outcomes (N = 110)

Univariate Analysis and Group Comparisons

Following the significant MANOVA, univariate mixed-design ANOVAs were performed for each outcome. As shown in Tables 4 and 5, significant Time × Group interactions were found for all variables (all P < 0.001).(Figure 2)

Table 4 Psychological Outcomes and Mixed-Design ANOVA Results (N = 110)

Table 5 Mixed-Design ANOVA Results for Study Outcomes (Time × Group) (N = 110)

Figure 2 Line graph showing changes in confidence in coping strategies. Line graphs showing changes in (A) Anxiety, (B) Confidence in coping strategies, (C) Avoidance, and (D) Total scores from baseline (Pre) to post-intervention (Post) between the Control group and the WIKAP intervention group. Values are estimated marginal means adjusted for the mixed-design ANOVA model. Error bars represent 95% confidence intervals.

HbA1c Outcomes Between Two Groups

HbA1c decreased from pre to post in the control group and the WIKAP group. Mixed-design ANOVA showed no significant time × group interaction and no significant main effect of group. The main effect of time approached significance. Although the interaction did not reach statistical significance, the clinical trend suggests improved glycemic control in both groups over time. (Tables 6 and 7)

Table 6 Means and Standard Deviations of Outcomes by Group and Time (M ± SD) (N = 110)

Table 7 Mixed-Design ANOVA Results for HbA1c Outcomes (Time × Group) (N = 110)

Hypoglycemia Incidence Between Two Groups

The incidence of hypoglycemia differed between the control and WIKAP groups (Table 8).

Table 8 Comparison of the Incidence of Hypoglycemia Between the Two Groups (N = 110)

Primary Caregiver Satisfaction

Primary caregiver satisfaction differed significantly between the control and WIKAP groups (Table 9).

Table 9 Comparison of the Nursing Satisfaction of the Main Caregivers of the Two Groups of Patients (N = 110)

Discussion

WIKAP’ Mechanism of Action

The effectiveness of the WIKAP intervention in this study stems from its foundation in the KAP framework, which integrates information delivery, knowledge acquisition, belief formation, and behavioral practice to convert health-related knowledge into enduring self-care behaviors. Structured education enables patients to heighten disease awareness, build self-management confidence, and enact positive attitudes through practical changes, leading to enhanced glycemic control. This mechanism, rooted in WIKAP theory, promotes tailored knowledge acquisition that strengthens self-care and hypoglycemia management confidence. It facilitates the translation of knowledge into behaviors that resolve rehabilitation issues. Interactive features, including group discussions for experience sharing, boosted coping strategies and alleviated anxiety, as evidenced by a participant’s statement:

I had similar symptoms before. As soon as they occurred, I panicked and didn’t know how to deal with them. Now I have more confidence in handling hypoglycemia and won’t be anxious or scared because of this.

Adolescents with T1DM frequently struggle with disease acceptance, fostering anxiety while juggling academic and daily responsibilities; the WIKAP method counters these emotions via guided support. Limited skill development during brief hospitalizations worsens post-discharge challenges, especially in rural areas with scarce resources. By filling this void, the model reduces anxiety, fortifies disease management, and decreases hypoglycemia incidence. Comparable mechanisms are supported in recent literature. For example, a study of 417 diabetic adolescents in Jordan revealed moderate-to-high knowledge levels but poor attitudes and practices, underscoring the need for targeted education to improve management.³⁵ Additionally, a study on recurrent education for children and adolescents with T1DM demonstrated enhanced hypoglycemia awareness, appropriate self-treatment, and reduced fear through repeated sessions, aligning with KAP principles.³⁶ Furthermore, a review of age-based T1DM challenges in pediatrics highlighted the role of structured DSME in addressing self-management barriers, anxiety, and hypoglycemia risks in adolescents.¹⁰

Effectiveness of the WIKAP Intervention in Enhancing Hypoglycemia Coping and Reducing Incidence in Adolescents with T1DM

The study findings indicate that the WIKAP intervention significantly enhanced hypoglycemia coping outcomes in adolescents with T1DM in the observation group relative to controls. To rigorously evaluate these multi-faceted psychological changes, we employed a doubly multivariate MANOVA, which revealed a highly significant interaction effect (p< 0.001). This multivariate approach accounted for the inherent correlations between anxiety, avoidance, and confidence, confirming that the WIKAP model produced a robust, systemic improvement in the overall coping profile rather than mere fragmented changes. Mixed analyses of variance showed notable time effects and time-by-group interactions across dimensions, highlighting the intervention’s distinct influence. Anxiety declined substantially in the WIKAP group but remained consistent in controls, with post-intervention anxiety scores notably lower in the observation group. Comparable reductions in anxiety and fear of hypoglycemia have been reported in recent research, such as a feasibility trial of the cognitive behavioral and technology-aided intervention (FREE), which demonstrated notable fear reductions in young adults with T1D.³⁷ Furthermore, a randomized trial assessing the Bring Blood Glucose Down! Intervention indicated reduced hypoglycemia fear in caregivers of T1DM adolescents.³⁸ The Standards of Care in Diabetes also emphasize preventing diabetes distress in adolescents with T1DM through targeted programs.³⁹

Avoidance behaviors improved markedly in the WIKAP group, with minimal changes in controls. This aligns with educational strategies that promote proactive self-management, as seen in a cross-sectional analysis of pediatric T1DM self-care, which revealed that sufficient parental involvement mitigates severe hypoglycemia risks and supports behavioral adaptations.⁴⁰ Additionally, a review advocated classroom-based self-care for T1D adolescents to optimize insulin dosing and prevent hypoglycemia through team-led education.⁴¹

Confidence and total coping scores exhibited pronounced elevations in the WIKAP group, with post-intervention confidence scores notably higher in the observation group. Similar enhancements in self-efficacy and coping are supported by a prospective study on recurrent education for T1DM youth, which showed improved hypoglycemia awareness, appropriate self-treatment, and reduced fear via repeated sessions.³⁶ The Children and Adolescents Standards of Care in Diabetes highlight psychological interventions for adherence, metabolic control, and coping with stress in this population.⁴²

The intervention also led to decreased hypoglycemia incidence attributable to enhanced knowledge and behavioral adaptations. This outcome is consistent with findings from a study using structural equation modeling, which linked better knowledge and attitudes to improved dietary and activity practices in diabetic patients.⁴³ A randomized trial on educational impacts for type 2 diabetes nutritional adherence showed gains in knowledge, attitudes, practices, and metabolic markers, including reduced glucose levels.^44,45 Another study on diabetic weight management identified moderate knowledge levels and positive knowledge-attitude-practice correlations, emphasizing targeted education for self-management.⁴⁶

The WIKAP Intervention Model’s Impact on Glycemic Control, Hypoglycemia Incidence, and Caregiver Satisfaction in Adolescents with T1DM

HbA1c levels decreased modestly from pre- to post-intervention in both the control group and the WIKAP group, with no significant time-by-group interaction or main effect of group observed in the mixed-design ANOVA. The main effect of time approached statistical significance, suggesting a general trend toward improvement irrespective of the intervention. This finding aligns with a Meta-analysis indicating that educational and psychoeducational self-management interventions yield only small short-term reductions in HbA1c among children and adolescents with type 1 diabetes, with no sustained effects at longer follow-ups and high heterogeneity across studies.⁴⁷ However, it contrasts with a prospective interventional study demonstrating that tailored diabetes education significantly lowered HbA1c and enhanced glycemic control in pediatric patients transitioning to continuous subcutaneous insulin infusion, highlighting the potential variability in intervention efficacy based on delivery methods and patient contexts.⁴⁸

The incidence of hypoglycemia was significantly lower in the WIKAP group compared to the control group, as evidenced by chi-square analysis, with fewer occurrences across all severity levels in the intervention participants. This outcome supports the role of structured educational models in mitigating hypoglycemic events through improved self-management. A study on recurrent education for children and adolescents with T1DM reported significant reductions in hypoglycemia duration and incidence, alongside enhanced awareness and appropriate self-treatment, following targeted sessions on monitoring and prevention.³⁶ Similarly, a Meta-analysis of non-pharmacological interventions, including education, noted improvements in overall glycemic control that indirectly contribute to reduced hypoglycemia risks, although direct effects on incidence were not isolated in the analysis.⁴⁹

Primary caregiver satisfaction was significantly higher in the WIKAP group than in the control group post-intervention, as confirmed by chi-square comparison, reflecting enhanced engagement and support through personalized health education inclusive of caregivers. This result underscores the value of family-oriented approaches in fostering positive caregiving experiences. A mixed-methods feasibility study evaluating a digital caregiving platform for families of children with T1DM found significant improvements in caregiver mood, well-being, and satisfaction, with reductions in depression, anxiety, and stress over a three-month period.⁵⁰ Additionally, a Meta-analysis of psychological interventions for families of children with T1DM demonstrated reductions in caregiver psychological distress post-intervention, which correlates with increased satisfaction and better family functioning in diabetes management.⁵¹

Our study has several limitations. First, the prospective, quasi-experimental design and purposive sampling were adopted to minimize treatment contamination in a single-center clinical setting; however, these approaches may have introduced selection and temporal biases. We addressed these concerns through independent screening and rigorous statistical adjustments. Specifically, we employed ANCOVA to control for baseline imbalances and used MANOVA to account for the inter-correlations between psychological dimensions, thereby providing a more integrated and robust estimation of the intervention’s effects. Despite these constraints, this study provides a robust pragmatic foundation for the model’s efficacy. Future multicenter cluster-randomized trials are warranted to further validate these results across broader populations.

Conclusion

This study demonstrates that the WIKAP intervention effectively enhances hypoglycemia coping confidence and reduces anxiety in adolescents with T1DM, while also decreasing hypoglycemia incidence and improving primary caregiver satisfaction, with statistically significant differences compared to controls. Although HbA1c levels showed a modest decline across groups without intervention-specific effects, these outcomes underscore the model’s utility in fostering self-management and family support, grounded in the KAP framework. Despite these advancements, domestic research on T1DM hypoglycemia coping confidence remains limited. Study constraints include a single-center sample potentially introducing selection bias, reliance solely on the HABS scale’s anxiety dimension without dedicated anxiety assessments, exclusive use of HABS for coping evaluation, and a short 8-week duration lacking long-term psychosocial follow-up. Future investigations should employ multi-center designs with larger cohorts to validate findings, incorporate supplementary tools for anxiety and coping measurement, and conduct extended randomized controlled trials to assess sustained impacts.