Transition to Hospital Discharge in Insulinized Patients With Type 2 Diabetes Mellitus

Percentage of time that interstitial glucose values are below the target range (<70 mg/dL), as measured by continuous glucose monitoring (CGM). TBR will be subdivided into:

Time in level 1 hypoglycemia: 54-69 mg/dL

Time in level 2 hypoglycemia: <54 mg/dL

These thresholds align with the International Consensus on Time in Range.

Unit of Measurement: Percentage (%) of time below range

Method of Assessment:

Data will be extracted from CGM devices (DEXCOM ONE +). The percentage of time spent below each threshold will be calculated using validated software platforms following consensus CGM data analysis protocols.

Percentage of time that interstitial glucose values are above the target range (>180 mg/dL), as measured by CGM. TAR will be subdivided into:

Time in level 1 hyperglycemia: 181-250 mg/dL

Time in level 2 hyperglycemia: >250 mg/dL

Unit of Measurement:

Percentage (%) of time above range

Method of Assessment:

Data will be extracted from CGM device (DEXCOM ONE +). The percentage of time spent above each threshold will be calculated using validated software platforms following consensus CGM data analysis protocols.

The coefficient of variation (CV) of interstitial glucose values over the monitoring period. CV represents glycemic variability and is calculated as the ratio of the standard deviation to the mean glucose level, expressed as a percentage.

Unit of Measurement:

Percentage (%)

Method of Assessment:

Calculated automatically from CGM data using standard formula: CV = (SD / Mean) × 100. The value will be derived from at least 10 days of valid CGM data, in line with consensus guidelines.

Average interstitial glucose level (mg/dL) measured over the CGM monitoring period. This reflects overall glycemic exposure during the follow-up.

Unit of Measurement:

Milligrams per deciliter (mg/dL)

Method of Assessment:

Mean glucose will be calculated from CGM recordings collected over the study period, requiring at least 70% device wear-time for valid analysis.

Measurement of glycated hemoglobin (HbA1c), which reflects the average blood glucose concentration over the previous 2-3 months. HbA1c is a standard laboratory marker used to assess long-term glycemic control in patients with diabetes.

Unit of Measurement:

Percentage (%)

Method of Assessment:

HbA1c will be obtained through standard blood analysis performed during hospitalization and at the 12-week follow-up visit.

Assessment of patient health-related quality of life. It will be assessed using the EQ-5D-5L (EuroQol). Outcomes will include the EQ-5D-5L index value derived from the 5 dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) and the EQ visual analogue scale (EQ V

Unit of measurement EQ-5D-5L index value (unitless score) EQ visual analogue scale (EQ VAS), points (0-100)

Method of assessment Self-administered EQ-5D-5L questionnaire, including 5 dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression) with 5 levels each, and the EQ VAS. Higher scores indicate better perceived health status.

Evaluation of the rate of unplanned hospital readmissions within 30 days following hospital discharge. A sub-analysis will be conducted to classify readmissions based on whether the primary cause was diabetes-related (e.g., hypoglycemia, hyperglycemia, diabetic complications) or non-diabetes-related.

Unit of Measurement:

Percentage (%) of participants experiencing hospital readmission.

Method of Assessment:

Hospital readmission data will be obtained through review of electronic health records and patient interviews. Only unplanned hospitalizations will be included; planned admissions (e.g., scheduled procedures) will be excluded.

Evaluation of the number of insulin doses administered outside the recommended time window. This includes basal insulin doses administered more than 60 minutes later than scheduled and bolus insulin doses administered more than 15 minutes after the start of the meal. This outcome reflects deviations from the prescribed insulin timing and may indicate suboptimal treatment adherence or workflow issues.

Unit of Measurement:

Number of delayed insulin doses per participant

Method of Assessment:

Data will be obtained from a connected insulin pen device (Insulclock®), which automatically logs the date and time of each insulin administration. Meal times and prescription schedules will be recorded to determine whether each dose was administered on time or delayed.

Several analytical parameters will be assessed in the participants and reported in the Outcome Measure results data table. Blood and urine samples will be collected and analyzed in certified clinical laboratories using standard methods. The following parameters will be measured:

Blood parameters (units):

Fasting glucose: mg/dL

Uric acid: mg/dL

GGT: U/L

Total cholesterol: mg/dL

HDL cholesterol: mg/dL

LDL cholesterol: mg/dL

Triglycerides: mg/dL

ALT (GPT): U/L

AST (GOT): U/L

Sodium: mEq/L

Potassium: mEq/L

Chloride: mEq/L

Estimated glomerular filtration rate (eGFR): mL/min/1.73m²

Creatinine: mg/dL

Albumin: g/dL

Glycated hemoglobin (HbA1c): %

C-peptide: ng/mL

FIB-4 index: unitless

Urine parameters:

Albumin-to-creatinine ratio (ACR): mg/g creatinine

Urine culture: positive / negative (qualitative)

Description:

Assessment of whether the patient received systemic corticosteroids at any point during the index hospitalization.

Unit of Measurement:

Yes / No

Method of Assessment:

Information will be obtained from the electronic medical record.

Assessment of whether the patient was prescribed systemic corticosteroids at the time of hospital discharge.

Unit of Measurement:

Yes / No

Method of Assessment:

Information will be obtained from the hospital discharge summary in the electronic medical record.

Assessment of total daily insulin dose prescribed at discharge, categorized as ≥0.5 or <0.5 units/kg/day.

Unit of Measurement:

Dichotomous: ≥0.5 units/kg/day vs. <0.5 units/kg/day

Method of Assessment:

Total daily insulin dose and patient body weight will be extracted from the medical record to calculate the units per kilogram per day.

Assessment of total daily insulin dose prescribed at 12 weeks post-discharge, categorized as ≥0.5 or <0.5 units/kg/day.

Unit of Measurement:

Dichotomous: ≥0.5 units/kg/day vs. <0.5 units/kg/day

Method of Assessment:

Total daily insulin dose and patient body weight will be extracted from the medical record to calculate the units per kilogram per day.

Duration of the index hospitalization, expressed in total number of days from admission to discharge.

Unit of Measurement:

Number of days

Method of Assessment:

Calculated from hospital admission and discharge dates recorded in the electronic medical record.

Assessment of whether the patient was prescribed any oral antidiabetic medication at the time of hospital discharge. In addition to the yes/no categorization, the specific type(s) of oral antidiabetic agents prescribed (e.g., metformin, DPP-4 inhibitors, SGLT2 inhibitors, sulfonylureas, etc.) will also be recorded.

Unit of Measurement:

Yes / No; plus descriptive list of prescribed agents

Method of Assessment:

Data will be obtained from the discharge medication list recorded in the electronic medical record. The presence or absence of oral antidiabetic therapy will be noted, along with the names of the active substances prescribed.

Measurement of body weight taken with a calibrated scale during hospitalization (baseline) and at 12 weeks post-discharge to assess changes in body composition.

Unit of Measurement:

Kilograms (kg)

Method of Assessment:

Weight will be measured using a calibrated digital scale at both time points.

Measurement of participant height to calculate body mass index and assess baseline anthropometrics.

Unit of Measurement:

Meters (m)

Method of Assessment:

Height will be measured using a stadiometer at enrollment.

Calculation of body mass index (BMI) using weight and height measured at baseline.

Unit of Measurement:

Kilograms per square meter (kg/m²)

Method of Assessment:

BMI will be calculated as weight (kg) divided by height squared (m²)

Categorization of participants into global cardiovascular risk groups according to clinical criteria defined in the 2019 ESC/EAS Guidelines for the Management of Dyslipidaemias. Risk levels are determined without the use of SCORE or SCORE2 equations, based on comorbidities, lipid levels, blood pressure, diabetes duration, kidney function, and the presence of established cardiovascular disease or target organ damage.

Unit of Measurement:

Categorical: Low / Moderate / High / Very high

Method of Assessment:

Participants will be classified into one of four risk categories:

Very high risk: Established cardiovascular disease, chronic kidney disease stage IV (eGFR <30 mL/min), diabetes with target organ damage or ≥3 major cardiovascular risk factors, or long-standing type 1 diabetes (>20 years)

High risk: Diabetes duration ≥10 years or with additional risk factors, familial hypercholesterolemia without organ damage, chronic kidney disease stage III

Brief description Medication adherence assessed using the 4-item Morisky-Green test (MMAS-4).

Unit of measurement Morisky-Green adherence classification (complier vs non-complier).

Method of assessment Self-reported 4-item Morisky-Green questionnaire (yes/no responses). Participants are classified as adherent (complier) when all responses indicate adherence; otherwise, they are classified as non-adherent (non-complier).