Continuous Bloodsugar Monitoring System With a Sensor Compared to Fingerstick Bloodsugar Monitoring

NCT06473480 | Recruiting FDA Device

• 1 other identifier: GLUCOSENS
• Study Type: interventional
• Target: 329
• Locations: 1 country
• Sites: 2

Brief Summary

This clinical trial aims to compare a continuous glucose monitoring system with traditional fingerstick blood glucose monitoring. The study focuses on adult patients in general surgical wards who need regular blood glucose checks due to the risk of low or high blood sugar levels. The goal is to learn if using a continuous glucose monitoring system is better than fingerstick monitoring in managing glucose levels, preventing complications, improving patient satisfaction and experience, reducing nursing staff workload, and improving nursing staff' experience. The study also compares the accuracy of glucose readings from the continuous glucose monitoring system with those from fingerstick tests and blood samples. The hypothesis is that CGMS is accurate and effective for monitoring glucose levels in surgical patients. This could lead to better blood sugar control, fewer complications, shorter hospital stays, and improved experiences for both patients and nursing staff.

Conditions

Diabetes Mellitus; Hypoglycemia (Diabetic); Hypoglycemia Night; Hyperglycemia

Keywords

Blood glucose monitoring; point-of-care fingerstick capillary glucose monitoring; continuous glucose monitoring system; Patient satisfaction; Patient experience; Nursing staff's workload; Nursing staff's experience; accuracy

Outcome Measures

Primary Outcomes (5)

• Substudy 1: Mean daytime and nocturnal point-of-care glucose levels

  Point-of-care glucose levels measured by point-of-care continuous glucose monitoring system (CGMS) or point-of-care fingerstick capillary glucose monitoring (FSGM) Arm allocation: Period 1: FSGM Period 2: CGMS Number of measurements: minimum four times daily, hourly if fasting. Blood glucose measurement: mmol/L

  During hospitalization (up to 30 days)

• Substudy 2: Patient-reported outcome on the convenience of glucose monitoring

  Using the validated Danish version of the 22-item questionnaire: The Diabetes Treatment Satisfaction Questionnaire for Inpatients (DTSQ-IP), item 4: How convenient did you think the diabetes treatment was at hospitalization? Ranging from 0 - 6 0 represents 'At no time' 6 represents 'At most of the time'

  During hospitalization (up to 30 days)

• Substudy 3: Mean minutes surgical nursing staff spent on bedside glucose monitoring

  Mean time: minutes. Data include: * Profession * Preparation (gathering materials, handwashing, disinfecting hands, putting on gloves, etc.) * Time for fingerstick or scanning of the continuous glucose monitor sensor * Display time of glucose level on device * Glucose level (mmol/L) * Actions taken after measurement (insulin injection, handwashing, documentation, disinfection, etc.) * Time for leaving the room * Time for completed procedure including documentation * Other observations made during the measurement

  During hospitalization (up to 30 days)

• Substudy 5: Percentage of time in range (3.9-10.0 mmol/l) during the entire hospital stay

  Percentage of time in range (3.9-10.0 mmol/l) during the entire hospital stay

  During hospitalization (up to 30 days)

• Substudy 6: Differences in interstitial and plasma glucose

  Glucose levels from CGMS are compared to plasma glucose, which are co-analyzed in blood tests.

  During hospitalization (up to 30 days)

Secondary Outcomes (36)

• Substudy 1: • Mean dose of short-acting insulin (IE)

  During hospitalization (up to 30 days)

• Substudy 1: Mean dose of long-acting insulin (IE)

  During hospitalization (up to 30 days)

• eGFR

  During hospitalization (up to 30 days)

• Substudy 1: Complication: Sepsis

  During hospitalization (up to 30 days)

• Substudy 1: Complication: Acute kidney failure

  During hospitalization (up to 30 days)

Study Arms (3)

PERIOD 1: Point-of-care fingerstick glucose monitoring = standard care

NO INTERVENTION

Subjects' blood glucose levels are monitored using point-of-care fingerstick capillary glucose monitoring (standard care), which is conducted by surgical ward nurses according to a predefined schedule. Diabetes treatment management is overseen by specific in-house diabetes nurses. Treatment decisions are based on point-of-care fingerstick capillary glucose values.

PERIOD 2: Glucose monitoring system as point-of-care = study intervention

ACTIVE COMPARATOR

The sensor from the continuous glucose monitoring system is scanned by surgical nurses as point-of-care according to the predefined schedule, as in standard care. Monitoring is conducted by surgical ward nurses. Diabetes treatment management is overseen by specific in-house diabetes nurses. Diabetes nurses' treatment decisions are based on the continuous glucose monitoring system values.

Device: Abbott FreeStyle Libre System 2 Plus

PERIOD 3: Point-of care fingerstick glucose monitoring = standard care + blinded sensor

EXPERIMENTAL

PERIOD 3: Same as for period 1, but with a blinded sensor (FreeStyle Libre Pro). The data from the blinded sensors are concealed from both participants and nurses and will be used for comparison with the experimental arm. This study period is only conducted at OUH.

Device: Abbott Freestyle Libre Pro

Interventions

Abbott FreeStyle Libre System 2 Plus DEVICE

The sensor is placed subcutaneously at the back of the participant's upper arm with one insertion and measures the subcutaneous glucose concentration.

PERIOD 2: Glucose monitoring system as point-of-care = study intervention

Abbott Freestyle Libre Pro DEVICE

The sensor is placed subcutaneously at the back of the participant's upper arm with one insertion and measures the subcutaneous glucose concentration.

PERIOD 3: Point-of care fingerstick glucose monitoring = standard care + blinded sensor

Eligibility Criteria

• Age: 18 Years - 110 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Hospitalized patients (≥ 18 years old) in surgical wards
• Glucose measurements at least 4 times (OUH) and 3 times (SUH) daily for at least three days, prescribed by surgeon
• Expected hospitalization for at least three days
• Communicates in Danish
• Signed a declaration of consent to study participation
• At risk of hypo- and hyperglycemia (with or without a diabetes diagnosis)

You may not qualify if:

• Cognitively impaired patients
• Indication for glucose monitoring solely because of parenteral nutrition treatment
• Patients admitted with a CGMS
• Patients from the point-of-care fingerstick capillary glucose monitoring group cannot be included in the continuous glucose monitoring system group
• Eligibility criteria solely for substudy 7
• Nursing staff with at least one month of experience with both point-of-care fingerstick capillary glucose monitoring and continuous glucose monitoring system and are registered nurses or certified nursing assistants

Sponsors & Collaborators

• Odense University Hospital: lead
• Zealand University Hospital: collaborator

Study Sites (2)

Department of Surgery, Zealand University Hospital

Køge, Køge, 4600, Denmark

RECRUITING

The Department of Surgery, Odense Univeristy Hospital

Odense, Odense, 5000, Denmark

RECRUITING

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Related Links

• Prevalence of patients with diagnosed diabetes in Denmark in 2022
• Incidence of diabetes worldwide
• User's guide for Abbotts' freestyle libre devices

MeSH Terms

Conditions

Diabetes Mellitus; Hypoglycemia; Hyperglycemia; Patient Satisfaction

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Officials

• Karoline Schousboe, MD, PhD

  Steno Diabetes Center Odense, Odense University Hospital

  STUDY CHAIR

• Helen Schultz, RN, PhD

  The Department of Surgery, Odense University Hospital

  STUDY CHAIR

Central Study Contacts

Helen Schultz, RN, PhD

CONTACT

+4522401513; Helen.Schultz@rsyd.dk

Karoline Schousboe, MD, PhD

CONTACT

+4524349740; Karoline.Schousboe@rsyd.dk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: PERIOD 1: Point-of-care fingerstick glucose monitoring = Standard care, 110 patients * Substudy 1-3: 110 patients * Substudy 4: 14 patients of the 110 patients PERIOD 2: Point-of-care continuous glucose monitoring system = study Intervention 110 patients and 24 nursing staff * Substudy 1-3: 110 patients * Substudy 4: 20 patients of the 110 patients * Substudy 5\*: 85 patients of the 110 patients * Substudy 6\*: 85 patients of the 110 patients * Substudy 7: 24 nursing staff (20 surgical nursing staff and 4 specialized diabetes nurses) PERIOD 3\*: Point-of-care fingerstick glucose monitoring = standard care + blinded sensor, 85 patients * Substudy 5\*: 85 patients * Substudy 6\*: 85 patients * Only conducted at Odense University Hospital

Study Record Dates

• First Submitted: May 14, 2024
• First Posted: June 25, 2024
• Study Start: June 26, 2024
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: April 3, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

DK (2)