Transition to Hospital Discharge in Insulinized Patients With Type 2 Diabetes Mellitus
NCT ID: NCT07061301
Last Updated: 2026-01-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
80 participants
INTERVENTIONAL
2024-08-01
2026-07-31
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Use of blind continuous glucose sensor and smart insulin pen cap.
From discharge, use of a blind continuous glucose sensor and a smart insulin pen cap. Insulin therapy decision-making based on capillary blood glucose.
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.
Use of continuous glucose sensor and smart insulin pen cap and is able to see the parameters.
From discharge, a continuous glucose sensor and smart insulin pen cap are used, and the subject is able to see its parameters. Insulin therapy decision-making is based on the continuous glucose sensor and smart cap parameters.
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.
Interventions
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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.
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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
70 Years
ALL
No
Sponsors
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Instituto de Investigacion Sanitaria La Fe
OTHER
Responsible Party
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Juan Francisco Merino Torres
Chief of Endocrinology, Professor of Medicine, and Principal Investigator
Principal Investigators
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JUAN FRANCISCO MERINO TORRES, Medicine
Role: PRINCIPAL_INVESTIGATOR
IIS La Fe
DARIO LARA GALVEZ, Medicine
Role: STUDY_CHAIR
IIS La Fe
MATILDE RUBIO ALMANZA, Medicine
Role: STUDY_CHAIR
IIS La Fe
Locations
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Hospital La Fe, Valencia
Valencia, Valencia, Spain
Countries
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Central Contacts
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Facility Contacts
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References
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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.
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.
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.
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.
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.
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.
Other Identifiers
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2024-0338-1
Identifier Type: -
Identifier Source: org_study_id
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