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

Official title

Transition to Hospital Discharge in Insulinized Patients With Type 2 Diabetes Mellitus and Incorporation Into a Comprehensive Diabetes Management System

Overview

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.

Detailed description

The transition from hospital to home is a clinically vulnerable phase for patients with type 2 diabetes mellitus (T2DM), particularly for those who are newly initiated on insulin therapy during hospitalization. This period is characterized by increased therapeutic complexity, limited patient confidence with insulin use, and heightened risk of poor glycemic outcomes. Suboptimal adherence to insulin regimens-including missed or delayed doses-is common and has been associated with adverse clinical events, reduced quality of life, and higher healthcare utilization, including unplanned readmissions.

While continuous glucose monitoring (CGM) systems and smart insulin pen caps have individually shown promise in improving glycemic control and treatment adherence, there is a lack of robust data regarding their effectiveness when introduced in the peri-discharge period. Importantly, the transition from inpatient to outpatient care has been highlighted as a critical moment to implement structured, technology-supported interventions aimed at improving self-management and continuity of care.

This study investigates whether the combination of CGM and Insulclock® technology, initiated during hospitalization and continued after discharge, improves glycemic control and adherence in insulin-treated T2DM patients. Unlike prior studies, this trial evaluates these devices not only as monitoring tools but also as real-time decision-making supports during a period of high clinical risk.

In addition to assessing standard glycemic metrics - including time in range (TIR), time below and above range (TBR, TAR), coefficient of variation, and HbA1c - the study will measure patient-reported treatment satisfaction and unplanned hospital readmissions within 30 days. The outcomes of this research may inform future protocols for diabetes discharge planning and support the integration of connected technologies into standard care pathways for insulin initiation in hospitalized patients.

Interventions

• Device Usual Care group
  Participants 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.
• Device Technological group
  Participants 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.

Primary outcome measures

• Therapeutic adherence [Time frame: From baseline (hospital discharge) to 12 weeks post-discharge]
• Time in Range [Time frame: From baseline (hospital discharge) to 12 weeks post-discharge]

Secondary outcome measures (12)

• Time Below Range [Time frame: From baseline (hospital discharge) to 12 weeks post-discharge]
• Time Above Range [Time frame: From baseline (hospital discharge) to 12 weeks post-discharge]
• Coefficient of Variation [Time frame: From baseline (hospital discharge) to 12 weeks post-discharge]
• Mean Glucose Level [Time frame: From baseline (hospital discharge) to 12 weeks post-discharge]
• Glycated Hemoglobin (HbA1c) [Time frame: At 12 weeks post-discharge]
• Health-related quality of life assessed using the EQ-5D-5L (EuroQol) [Time frame: At 12 weeks post-discharge]
• Re-hospitalization Rate [Time frame: Within 30 days post-discharge]
• Number of off-schedule insulin administrations [Time frame: From hospital discharge to 12 weeks post-discharge]
• Number of participants with abnormal laboratory tests results [Time frame: During index hospitalization (baseline) and 12 weeks post-discharge]
• Use of corticosteroids during hospitalization [Time frame: During hospitalization (baseline)]
• Use of corticosteroids at discharge [Time frame: At hospital discharge to 12 weeks post-discharge]
• Insulin dose intensity at discharge [Time frame: Baseline]

Eligibility criteria

Inclusion criteria

• 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.
• Adequate cognitive and functional capacity to manage the required devices: insulin pen, glucometer, continuous glucose monitoring (CGM) sensor, and Insulclock® cap.

Exclusion criteria

• 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.
• Patients undergoing dialysis.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Treatment

Study locations

Spain · 1 center

• Hospital La Fe, Valencia — Valencia

Publications

• Tian T, Aaron RE, Seley JJ, Longo R, Nayberg I, Umpierrez GE, Levy CJ, Klonoff DC. Use of Continuous Glucose Monitors Upon Hospital Discharge of People With Diabetes: Promise, Barriers, and Opportunity. J Diabetes Sci Technol. 2024 Jan;18(1):207-214. doi: 10.1177/19322968231200847. Epub 2023 Oct 2. PMID 37784246
• Peyrot M, Barnett AH, Meneghini LF, Schumm-Draeger PM. Insulin adherence behaviours and barriers in the multinational Global Attitudes of Patients and Physicians in Insulin Therapy study. Diabet Med. 2012 May;29(5):682-9. doi: 10.1111/j.1464-5491.2012.03605.x. PMID 22313123
• Robinson S, Newson RS, Liao B, Kennedy-Martin T, Battelino T. Missed and Mistimed Insulin Doses in People with Diabetes: A Systematic Literature Review. Diabetes Technol Ther. 2021 Dec;23(12):844-856. doi: 10.1089/dia.2021.0164. Epub 2021 Oct 26. PMID 34270324
• Tejera-Perez C, Chico A, Azriel-Mira S, Lardies-Sanchez B, Gomez-Peralta F; Area de Diabetes-SEEN. Connected Insulin Pens and Caps: An Expert's Recommendation from the Area of Diabetes of the Spanish Endocrinology and Nutrition Society (SEEN). Diabetes Ther. 2023 Jul;14(7):1077-1091. doi: 10.1007/s13300-023-01417-1. Epub 2023 May 15. PMID 37188930
• Galindo RJ, Ramos C, Cardona S, Vellanki P, Davis GM, Oladejo O, Albury B, Dhruv N, Peng L, Umpierrez GE. Efficacy of a Smart Insulin Pen Cap for the Management of Patients with Uncontrolled Type 2 Diabetes: A Randomized Cross-Over Trial. J Diabetes Sci Technol. 2023 Jan;17(1):201-207. doi: 10.1177/19322968211033837. Epub 2021 Jul 22. PMID 34293955
• Vinagre I, Mata-Cases M, Hermosilla E, Morros R, Fina F, Rosell M, Castell C, Franch-Nadal J, Bolibar B, Mauricio D. Control of glycemia and cardiovascular risk factors in patients with type 2 diabetes in primary care in Catalonia (Spain). Diabetes Care. 2012 Apr;35(4):774-9. doi: 10.2337/dc11-1679. Epub 2012 Feb 16. PMID 22344609

Identifiers

NCT: NCT07061301 · 2024-0338-1

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗