This clinical study explores whether adding technological tools during hospital discharge can help people with type 2 diabetes who are starting insulin therapy achieve better treatment adherence and blood glucose control once they return home. The discharge transition period includes both the final days of hospitalization and the first weeks to months after returning home.
When people with type 2 diabetes are hospitalized, they sometimes need to begin insulin therapy. After discharge, managing insulin properly is essential to avoid high or low blood sugar levels. However, many patients forget or delay insulin doses, which can lead to poor control of their diabetes.
This study will compare two groups of patients. All participants will be adults with type 2 diabetes, between 18 and 70 years old, who are newly starting insulin during their hospital stay.
Group 1 ("technological group") will use a continuous glucose monitor (CGM) and a smart insulin pen cap called Insulclock. These tools show real-time blood glucose data and record when and how much insulin is injected. Patients and doctors can use this information to better adjust treatment. Insulclock also includes alarms to remind patients of their doses.
Group 2 ("control group") will use the same devices, but they will not see the data in real time. Instead, they will manage their insulin based on standard finger-prick blood sugar checks four times a day, as typically done in standard care.
Both groups will be followed for 12 weeks after hospital discharge. Medical check-ins will occur in weeks 1, 2, 4, 8, and 12. Blood tests and treatment adjustments will be performed as needed.
The main goals are:
To measure if the use of technology helps patients stick to their insulin schedule (fewer missed or mistimed injections).
To see if it leads to better blood glucose control (e.g., more time within the recommended range, fewer episodes of low or high glucose).
To evaluate patient satisfaction with this technology and check if the number of unplanned hospital readmissions decreases.
The study will take place at Hospital Universitari i Politècnic La Fe in Valencia, Spain. Around 80 patients will participate.
This study is important because real-world data about the use of CGM and smart insulin devices during the hospital-to-home transition are limited. It may help improve diabetes care for people starting insulin after hospitalization.
Adults aged 18 to 70 years.
Hospitalized patients with a diagnosis of type 2 diabetes mellitus (T2DM), either newly diagnosed during admission or previously known but not previously treated with insulin.
Initiation of insulin therapy (basal, basal-plus, or basal-bolus regimen) during hospitalization, with planned continuation post-discharge.
Independent in basic activities of daily living.
Dependence in basic activities of daily living.
Any medical condition or functional limitation precluding the use of the CGM or the Insulclock® system.
Pregnancy or intention to become pregnant.
Diagnosis of type 1 diabetes mellitus.
Parallel
Usual Care group
DeviceParticipants will use the same CGM and Insulclock® devices, but in blinded mode (no data available to the patient). Insulin therapy will be adjusted using capillary blood glucose measurements (4 times daily). Device data will be collected retrospectively but not used for treatment decisions.
Technological group
DeviceParticipants will use a real-time continuous glucose monitoring device (e.g., FreeStyle Libre 2) and the Insulclock® smart insulin pen cap. Both devices provide real-time feedback and data on insulin administration and glucose levels. Patients will adjust their insulin therapy based on these data.
Therapeutic adherence
Assessment of therapeutic adherence based on the number of injustified insulin administration omissions per week. Measured by Number of missed basal and bolus insulin doses within any 14-day period during follow-up. Method of Assessment: Data will be collected through the digital insulin pen smart cap system (Insulclock®), which automatically records each insulin administration and detects missed doses.
Time in Range
Percentage of time that interstitial glucose values remain within the target range of 70 to 180 mg/dL, as measured by continuous glucose monitoring (CGM). This metric reflects the effectiveness of glycemic control in patients with type 2 diabetes. TIR is widely recognized as a clinically meaningful outcome in diabetes technology studies. Unit of Measurement: Percentage (%) of time in target range Method of Assessment: data will be collected from continuous glucose monitoring systems (e.g., Dexcom G6 or equivalent), which record interstitial glucose every 5 minutes. TIR will be calculated over the monitoring period using standard CGM metrics, following international consensus guidelines. Justification: TIR has been endorsed as a key metric in diabetes management by the International Consensus on Time in Range. It correlates with reduced risk of microvascular complications and complements traditional measures such as HbA1c.
Time Below Range
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.
Time Above Range
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.
Coefficient of Variation
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.
Mean Glucose Level
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.
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