The study was approved by the Medical Ethics Committee of the Fourth Affiliated Hospital of Soochow University (No. 2025-251264), which approved a waiver of informed consent because anonymized routine clinical data were used. The research tools used for this protocol are listed in the Table of Materials.
1. Study design
This study used a retrospective propensity score-matching (PSM) cohort design. Clinical data were extracted from the electronic medical record (EMR) system for patients with T2DM who were hospitalized in the Department of Endocrinology of our hospital between June 1, 2024, and December 31, 2024.
2. Inclusion and exclusion criteria
The inclusion criteria were as follows: patients who met the diagnostic criteria for T2DM; were aged 18–85 years; had a hospital stay of at least 7 days and received standardized comprehensive treatment; had complete electronic medical records and follow-up data, including all core indicators at baseline and at 6 and 12 months after intervention; and were not transferred to another hospital or lost to follow-up during the follow-up period. The exclusion criteria were as follows: patients with type 1 diabetes mellitus, special types of diabetes mellitus, or gestational diabetes mellitus; those with severe psychiatric disorders or cognitive impairment (MMSE score < 24); those presenting with acute complications such as diabetic ketoacidosis or hyperosmolar hyperglycemic syndrome at admission; patients with malignant tumors, end-stage heart, liver, or kidney disease, or active severe infection; those with more than 20% missing baseline data or with key outcome indicators missing (HbA1c, SDS, or SDSCA); and patients participating in other clinical intervention studies during hospitalization.
3. Grouping
Observation group: During hospitalization, patients received a complete MDT lifestyle intervention. The electronic medical records contained documentation of a nutrition consultation within 48 h after admission, a psychological assessment within 72 h, an individualized management file established by a T2DM specialist nurse, and a 12-month follow-up management plan after discharge.
Conventional group
Patients received traditional T2DM management, had no MDT specialist consultation records, did not receive an individualized lifestyle intervention plan, and, after discharge, underwent only routine outpatient follow-up as required.
4. Sample size calculation
This study used a 1:1 PSM design, and the sample size was estimated based on the effect size for glycated hemoglobin (HbA1c) reported in previous similar studies14. According to earlier research14, it was assumed that integrated intervention could reduce HbA1c by an average of 0.8% compared with routine management, with a standard deviation of 1.2% in both groups. With a two-sided α = 0.05 and a test power of (1 − β) = 0.8, the formula for two independent-sample t tests indicated that at least 52 patients were required in each group. Considering that approximately 20% of cases might fail to match successfully during the PSM process because of differences in baseline characteristics, the final sample size was set at 65 patients per group. A total of 133 original cases yielded 130 valid samples after matching. The sample size calculation was based on HbA1c, which was defined as the primary outcome. The study was not separately powered for secondary outcomes; therefore, emotional status, self-management ability, health literacy, nutritional protein indicators, complication screening, newly developed complications, adherence, and satisfaction were interpreted as exploratory outcomes.
5. Intervention measures
The intervention period was 12 months in both groups, and outcomes were evaluated at 6 months (T1) and 12 months (T2) after intervention. All intervention measures were implemented in accordance with standardized hospital procedures, and the timing, frequency, and responsible personnel were documented in the electronic medical record. To improve reproducibility, the intervention procedures are described below according to care setting and MDT function.
Conventional diabetes management
The traditional “five pillars” model of T2DM management was adopted, and all procedures were carried out by the responsible nurse. During hospitalization, fingertip blood glucose was monitored daily in the fasting state and 2 h after each of the three meals using a calibrated bedside glucometer. When abnormal glucose levels were detected, additional measurements were performed at bedtime and at 3:00 a.m.
On the second hospital day, a 30 min group health-education session was delivered, covering basic knowledge of T2DM, general methods of blood glucose monitoring, principles of diet and exercise, medication use, and prevention of complications. On the day of discharge, a standardized educational booklet was provided, and patients were instructed to return to the general outpatient clinic every 3 months for follow-up or earlier if symptoms occurred.
After discharge, only routine outpatient follow-up was arranged. Each visit lasted 5–10 min and involved recording glycemic indicators and adjusting medication regimens. No structured lifestyle guidance, psychological assessment, or nutritional counseling was provided.
MDT team composition and integrated management
In addition to routine management, an MDT-based lifestyle-management pathway was implemented. A fixed MDT was established, consisting of two attending endocrinologists, three nationally certified T2DM specialist nurses, one attending nutrition physician, one attending psychologist, one general practitioner, and one physician from the Department of Traditional Chinese Medicine.
The MDT held a 1 h case-discussion meeting every Wednesday afternoon to jointly formulate and adjust intervention plans. Summary discussion records were retained in the clinical archive. MDT delivery was documented in routine clinical records, including a nutrition consultation within 48 h of admission, a psychological assessment within 72 h, establishment of an individualized management file, weekly MDT case discussions, telephone follow-up, outpatient follow-up, patient meetings, and WeChat-based check-ins.
Because these records were maintained primarily for routine clinical management rather than research auditing, standardized patient-level quantitative delivery data were not consistently available. Completion rates or frequencies for nutrition consultations, psychological assessments, telephone follow-up contacts, patient meetings, and WeChat participation could not be reliably extracted for all patients. Accordingly, these records were used to descriptively characterize the MDT-based management pathway, and no formal dose-response or component-level fidelity analysis was performed.
For obese patients with a body mass index (BMI) ≥ 28 kg/m2, acupoint catgut embedding was provided as an individualized adjunctive Traditional Chinese Medicine component following clinical evaluation. This intervention was not applied to all patients in the observation group and was recorded as a targeted component for eligible obese patients. Because it was embedded within the overall MDT pathway, its independent effect was not analyzed separately. The specific intervention process is shown in Table 1.
| Stage | Timing | Content | Personnel |
| In-hospital intervention | Within 24 h after admission | Baseline assessment of demographic characteristics, lifestyle, self-management ability, and health literacy | T2DM specialist nurse |
| In-hospital intervention | Within 48 h after admission | Individualized nutritional assessment and dietary plan formulation | Nutrition physician |
| In-hospital intervention | Within 72 h after admission | SDS/SAS assessment and targeted psychological intervention planning | Psychologist |
| In-hospital intervention | Throughout hospitalization | Individualized nutritional intervention, dietary management, and nutritional ward rounds | Nutrition physician; nutrition nurse |
| In-hospital intervention | Hospital day 5 | Family education on low-GI diet, ingredient proportions, and home cooking skills | Nutrition physician; nutrition nurse |
| In-hospital intervention | From hospital day 3 onward | Individualized exercise prescription and daily moderate-intensity aerobic exercise | Nurse |
| In-hospital intervention | From hospital day 4 onward | Acupoint catgut embedding therapy for obese patients with BMI ≥28 kg/m² | Physician of Traditional Chinese Medicine |
| In-hospital intervention | Throughout hospitalization | Supportive psychotherapy or cognitive behavioral therapy according to psychological status | Psychologist |
| In-hospital intervention | Within 3–5 days after admission | One-stop complication screening through the MMC platform | MDT team |
| Post-discharge continuity intervention | Within 1 week after discharge | First telephone follow-up focusing on role adaptation and implementation of diet and exercise | T2DM specialist nurse |
| Post-discharge continuity intervention | At 1, 3, and 9 months after discharge | Telephone follow-up, adherence monitoring, psychological assessment, and plan adjustment | T2DM specialist nurse; MDT team |
| Post-discharge continuity intervention | At 6 and 12 months after discharge | MDT joint outpatient follow-up, indicator reassessment, and complication screening | MDT team |
| Post-discharge continuity intervention | Monthly | Offline patient meetings, WeChat-based check-ins, health education, and centralized Q&A | MDT team |
Table 1: MDT-Based integrated lifestyle intervention protocol for the observation group. Components of the multidisciplinary team (MDT)-based integrated lifestyle-management pathway delivered to patients in the observation group during hospitalization and post-discharge follow-up.
6. Outcome hierarchy
The primary outcome was the change in HbA1c from baseline to 12 months. Secondary outcomes included changes in fasting plasma glucose, 2-hour postprandial plasma glucose, coefficient of variation of blood glucose, SDS and SAS scores, SDSCA score, HLS-SF12 score, serum nutritional protein indicators, complication screening completion, newly developed chronic complications, intervention adherence, and patient satisfaction. Because this was a retrospective cohort study and the sample size calculation was based solely on the primary HbA1c outcome, the secondary outcomes were exploratory and supportive and were not separately powered. Therefore, findings on psychological status, self-management ability, health literacy, protein-nutrition indicators, complication screening, newly documented complications, adherence, and satisfaction should be interpreted as hypothesis-generating observational associations.
7. Observation indicators
Negative emotions
Negative emotions were assessed using the Self-Rating Depression Scale (SDS) and Self-Rating Anxiety Scale (SAS)15. Assessments were conducted by nurses who had received standardized training and used uniform instructions. An SDS standard score ≥53 indicated depression, and an SAS standard score ≥50 indicated anxiety. Higher scores reflected more severe negative emotions.
Self-management ability
Self-management ability was assessed using the Summary of Diabetes Self-Care Activities (SDSCA)16, which includes 11 items across five dimensions: dietary management, exercise management, blood glucose monitoring, medication adherence, and foot care. Each item is scored from 0–7, with a total score ranging from 0–77. Higher scores indicate stronger self-management ability.
Health literacy
Health literacy was assessed using the Chinese version of the 12-item Health Literacy Scale Short Form (HLS-SF12)17, which comprises 12 items across three dimensions: healthcare, disease prevention, and health promotion. Total scores range from 12–60 points, with higher scores indicating greater health literacy. The Chinese HLS-SF12 has demonstrated acceptable reliability and validity in the Chinese population17; however, it has not been specifically validated in hospitalized Chinese patients with T2DM. Therefore, health literacy findings were interpreted cautiously.
Glycemic control indicators
Glycemic control indicators included fasting plasma glucose (FPG), 2-hour postprandial plasma glucose (2hPG), glycated hemoglobin (HbA1c), and the coefficient of variation of blood glucose (CV). Fasting and 2-h postprandial venous blood samples were collected. FPG and 2hPG were measured using an automatic biochemical analyzer, and HbA1c was measured by high-performance liquid chromatography. The coefficient of variation of blood glucose was calculated as:
CV = standard deviation / mean X 100%
Baseline history of insulin therapy was extracted from the EMR and included as a baseline characteristic. During the 12-month follow-up period, glucose-lowering treatment was adjusted by endocrinologists in accordance with routine clinical practice, outpatient glucose records, HbA1c results, hypoglycemia risk, and patient tolerance. Medication adjustments may include dose modifications, the addition or discontinuation of oral glucose-lowering drugs, and the initiation or adjustment of insulin therapy.
Complete baseline medication-class regimens and standardized follow-up medication-intensification data, including class-specific drug additions, dose escalations, discontinuations, or insulin adjustments, were not uniformly available in analyzable form. Therefore, medication intensification could not be modeled as a separate covariate, and glycemic outcomes were interpreted as associations with the overall MDT-based management pathway rather than as the independent effect of lifestyle management alone.
Nutritional protein indicators
Nutritional protein indicators included albumin (ALB), prealbumin (PA), transferrin (TRF), and retinol-binding protein (RBP). A 3 mL fasting venous blood sample was collected and allowed to stand at room temperature for 30 min, then centrifuged at 1505 × g at 4 °C for 10 min to separate the serum. Samples were analyzed within 2 h using an automatic biochemical analyzer and the corresponding reagents.
Dietary intake was assessed using a 3-day, 24-h dietary recall, including two weekdays and one weekend day where possible. Recalls were collected by uniformly trained nurses under the guidance of a nutrition physician. Daily high-quality protein intake and the proportion of animal versus plant protein intake were estimated using the China Food Composition Tables. Exercise behavior was assessed using the exercise dimension of the SDSCA and archived follow-up records.
Chronic complications and complication screening
The incidence of newly developed chronic T2DM complications within 12 months was recorded. A newly developed complication was defined as a chronic diabetes-related complication that was absent at baseline but newly diagnosed during follow-up.
Diabetic retinopathy was identified according to ophthalmologic examination or fundus photography showing diabetic retinal lesions. Diabetic nephropathy was identified according to newly documented albuminuria or a decline in estimated glomerular filtration rate consistent with diabetic kidney disease after exclusion of other obvious renal causes. Peripheral neuropathy was identified according to compatible symptoms or signs supported by foot examination, monofilament or vibration testing, or nerve-conduction assessment when available.
Complication status and the first documented diagnosis date were extracted from EMR records, outpatient follow-up records, and specialist reports. Two attending endocrinologists independently reviewed the records, and disagreements were resolved through discussion with a senior endocrinologist. Completion rates for retinopathy, nephropathy, and peripheral-neuropathy screening at 6 and 12 months were also recorded. Because the number of newly developed complications was limited, diagnosis dates were used for ascertainment and descriptive review rather than formal time-to-event modeling.
Patient satisfaction and intervention adherence
Patient satisfaction was evaluated using a self-designed T2DM management satisfaction questionnaire (Cronbach's α = 0.89), which included three dimensions—medical services, health education, and psychological support—with a total score of 100 points. The questionnaire demonstrated acceptable internal consistency in this cohort; however, formal construct validity and criterion validity testing had not been completed.
Medication adherence was assessed using the Morisky Medication Adherence Scale, whereas adherence to diet and exercise recommendations was assessed using a self-designed lifestyle-intervention adherence scale. Both measures were classified into three levels: complete adherence, partial adherence, and non-adherence. Complete medication adherence was defined as a high-adherence result on the Morisky Medication Adherence Scale, partial adherence as moderate adherence, and non-adherence as low adherence. Lifestyle adherence was classified using diet, exercise, follow-up, and lifestyle-management records. Complete adherence indicated that most planned lifestyle tasks were completed, partial adherence indicated incomplete but continued participation, and non-adherence indicated poor participation or discontinuation.
8. Outcome assessment
Laboratory outcomes were measured by the hospital laboratory using standardized procedures, and laboratory personnel were not involved in the delivery of interventions. Questionnaire-based outcomes were collected by trained nurses using standardized instructions. Because this was a retrospective study and the MDT pathway involved visible patient contacts, meetings, and follow-up activities, formal blinding of all outcome assessors was not feasible.
9. Statistical methods
Intergroup differences were compared using the independent-samples t test, and changes across time points within groups were analyzed using repeated-measures analysis of variance. Non-normally distributed continuous variables are presented as median (interquartile range) [M (P25, P75)], and intergroup comparisons were performed using the Mann–Whitney U test. Categorical variables are expressed as a number (percentage) [n (%)], and intergroup comparisons were conducted using the χ2 test or Fisher’s exact test.
For PSM, all baseline characteristics were treated as candidate variables. Variables with p < 0.1 identified by univariate logistic regression were selected as the final matching variables, including age, sex, duration of T2DM, and other relevant baseline characteristics. A 1:1 nearest-neighbor matching method was used with a caliper value of 0.05. Matching was performed without replacement, with an intended balance threshold of SMD < 0.2. Variables with residual imbalance after matching were examined carefully.
Because current smoking remained slightly above the prespecified threshold after matching, sensitivity analyses were performed with adjustment for current smoking. For the primary outcome, additional adjustment was performed for baseline HbA1c and baseline history of insulin therapy. A per-protocol analysis was also conducted among patients with complete lifestyle adherence.
Because detailed component-level delivery records were collected primarily for clinical management and were insufficiently standardized for quantitative exposure modeling, formal dose-response analysis by intervention intensity was not performed.
All statistical tests were two-sided, and p <0.05 was considered statistically significant. Exact p-values were reported for the primary outcome and for key tabulated between-group comparisons where available. For exploratory secondary outcomes presented primarily in figures, statistical significance was reported at the prespecified threshold of p < 0.05, and the corresponding statistical test was identified in the text or figure legend.