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

NCT07061301 | Recruiting

• 1 other identifier: 2024-0338-1
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Type 2 Diabetes Mellitus (T2DM); CGM; Continuous Glucose Monitoring; Transition to Discharge; Smart Insulin Pen Cap

Keywords

Type 2 Diabetes Mellitus; cgm; Continuous glucose monitoring; Transition to discharge; smart insulin pen cap; discharge; Insulinized patients

Outcome Measures

Primary Outcomes (2)

• 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.

  From baseline (hospital discharge) to 12 weeks post-discharge

• 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.

  From baseline (hospital discharge) to 12 weeks post-discharge

Secondary Outcomes (20)

• Time Below Range

  From baseline (hospital discharge) to 12 weeks post-discharge

• Time Above Range

  From baseline (hospital discharge) to 12 weeks post-discharge

• Coefficient of Variation

  From baseline (hospital discharge) to 12 weeks post-discharge

• Mean Glucose Level

  From baseline (hospital discharge) to 12 weeks post-discharge

• Glycated Hemoglobin (HbA1c)

  At 12 weeks post-discharge

Study Arms (2)

Use of blind continuous glucose sensor and smart insulin pen cap.

ACTIVE COMPARATOR

From discharge, use of a blind continuous glucose sensor and a smart insulin pen cap. Insulin therapy decision-making based on capillary blood glucose.

Device: Usual Care group

Use of continuous glucose sensor and smart insulin pen cap and is able to see the parameters.

EXPERIMENTAL

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.

Device: Technological group

Interventions

Usual Care group DEVICE

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 blind continuous glucose sensor and smart insulin pen cap.

Technological group DEVICE

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.

Use of continuous glucose sensor and smart insulin pen cap and is able to see the parameters.

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Instituto de Investigacion Sanitaria La Fe: lead

Study Sites (1)

Hospital La Fe, Valencia

Valencia, Valencia, 46026, Spain

RECRUITING

Related Publications (6)

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• JUAN FRANCISCO MERINO TORRES, Medicine

  IIS La Fe

  PRINCIPAL INVESTIGATOR

• DARIO LARA GALVEZ, Medicine

  IIS La Fe

  STUDY CHAIR

• MATILDE RUBIO ALMANZA, Medicine

  IIS La Fe

  STUDY CHAIR

Central Study Contacts

JUAN FRANCISCO MERINO TORRES, MEDICINE

CONTACT

+34617951330; merino_jfr@gva.es

DARIO LARA GALVEZ, Medicine

CONTACT

+34618205199; dario.galvez@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief of Endocrinology, Professor of Medicine, and Principal Investigator

Model Details: This is a pilot, randomized, open-label, parallel-group, single-center clinical trial. Adults with type 2 diabetes who start insulin therapy during hospitalization are randomized prior to discharge into two arms. The intervention group uses a real-time continuous glucose monitor (CGM) and Insulclock® smart cap, while the control group uses both blinded CGM and blinded Insulclock® smart cap and adjusts insulin based on capillary glucose tests. Both groups are followed for 12 weeks with scheduled visits at weeks 1, 2, 4, 8, and 12. The study evaluates adherence to insulin therapy and glycemic control during the hospital discharge transition period. Data are collected digitally in an electronic CRD. Glycemic control is assessed using time in range (TIR), time below range (TBR), time above range (TAR), coefficient of variation, mean glucose, and HbA1c.

Study Record Dates

• First Submitted: May 22, 2025
• First Posted: July 11, 2025
• Study Start: August 1, 2024
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: January 23, 2026

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)