Diathermy On Diabetes Glucose Monitoring Effectiveness

NCT07583238 | Not Yet Recruiting

• 1 other identifier: 25018
• Study Type: observational
• Target: 126
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this observational study is to investigate if diathermy (a surgical tool that uses electrical energy to control bleeding) has any affect on the accuracy and functioning of continuous glucose monitoring systems in adults and young people with Type 1 Diabetes. The main questions this study aims to answer is - \- Does the accuracy of continuous glucose monitoring systems change after use of diathermy? Participants will:

• Have their height and weight checked.
• Provide information about their medical history including type of diabetes, other medical conditions and any current medications they take.
• Have paired glucose meter and sensor glucose measurements taken every 15-75 minutes from up to 4 hours before surgery until up to 4 hours after the end of surgery.
• Have two blood samples taken to measure glucose levels, The first one will be before the use of diathermy and the second will be after the use of diathermy.

Conditions

Type 1 Diabetes Mellitis

Keywords

Continuous Glucose Monitoring Systems; Diathermy; Type 1 Diabetes Mellitus; Capillary blood glucose; Sensor blood glucose; Peri-operative care; Intra-operative T1DM management; pre-operative; post-operative; intraoperative

Outcome Measures

Primary Outcomes (1)

• To assess if the Absolute Relative Differences (ARDs) of continuous glucose monitoring systems change after use of diathermy.

  The ARD is the absolute difference between the sensor reading (mmol/L) and the reference (glucometer) glucose reading (mmol/L) divided by the reference reading. The null hypothesis is that there is no difference (non-inferiority) following diathermy (where equivalence is defined as less than a 0.05 difference in ARD).

  From up to 4 hours prior to the start of surgery to 4 hours after the end of surgery, for no more than a total of 24 hours.

Secondary Outcomes (9)

• To assess whether ARD changes following diathermy depending on type of diathermy used (bipolar/monopolar).

  From up to 4 hours prior to the start of surgery to 4 hours after the end of surgery, for no more than a total of 24 hours.

• To assess whether ARD changes following diathermy when the model is adjusted for glucose trend (rate of change).

  From up to 4 hours prior to the start of surgery to 4 hours after the end of surgery, for no more than a total of 24 hours.

• To assess whether ARD changes following diathermy when the model is adjusted for duration of surgery (minutes).

  From up to 4 hours prior to the start of surgery to 4 hours after the end of surgery, for no more than a total of 24 hours.

• To assess whether ARD changes following diathermy when the model is adjusted for site of surgery.

  From up to 4 hours prior to the start of surgery to 4 hours after the end of surgery, for no more than a total of 24 hours.

• To assess whether ARD changes following diathermy according to participant characteristic of age (years).

  From up to 4 hours prior to the start of surgery to 4 hours after the end of surgery, for no more than a total of 24 hours.

Study Arms (1)

Patients with T1DM aged 4 or older routinely using CGM systems undergoing elective surgery

Patients (aged 4 or above) with a diagnosis of type 1 diabetes mellitus who routinely use a prescribed Abbott Libre-2, Abbott Libre-3, Dexcom G6 or Dexcom G7 glucose monitoring system to monitor glucose concentrations. Patients will scheduled to have a planned admission for elective surgery.

Eligibility Criteria

• Age: 4 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients aged 4 or older with type 1 diabetes mellitus scheduled to undergo elective surgery at Nottingham Universities Hospitals NHS Trust.

You may qualify if:

• Diagnosis of type 1 diabetes mellitus.
• Planned admission for elective surgery at Nottingham University Hospitals NHS Trust.
• Currently routinely using a prescribed Abbott Libre-2, Abbott Libre-3, Dexcom G6 or Dexcom G7 glucose monitoring system to monitor glucose concentrations.
• Aged 4 years or older on the day of surgery.
• Ability to give informed consent / ability of parent/carer to give informed consent (as appropriate).

You may not qualify if:

• Use of paracetamol above maximum dose within 7 days before the scheduled date of surgery (in adults with body weight under 51kg - maximum of 60mg/kg per day, in adults with body weight 51kg and above - maximum of 4g per day, in children - maximum dose as per their age as stated in the British National Formulary for Children)
• Any use of hydroxyurea within 7 days before the scheduled date of surgery
• Use of more than 500mg per day of ascorbic acid / vitamin C within 7 days before the scheduled date of surgery
• Currently taking medications as part of a clinical trial.

Sponsors & Collaborators

• University of Nottingham: lead

Study Sites (1)

Queen's Medical Centre

Nottingham, United Kingdom

Location

Related Publications (9)

• Using technology to support diabetes care in hospital (2024). Joint British Diabetes Societies for Inpatient Care (JBDS-IP) Group and Diabetes Technology Network (DTN). Available at: https://abcd.care/sites/default/files/resources/JBDS_20_Using_Technology_to_Support_Diabetes_Care_in_Hospital_1.pdf (Accessed: 16 May 2024).

  BACKGROUND

• Type 1 diabetes in adults: QS208 (2023). National Institute for Health and Care Excellence. Available at: https://www.nice.org.uk/guidance/qs208.

  BACKGROUND

• Parkes JL, Slatin SL, Pardo S, Ginsberg BH. A new consensus error grid to evaluate the clinical significance of inaccuracies in the measurement of blood glucose. Diabetes Care. 2000 Aug;23(8):1143-8. doi: 10.2337/diacare.23.8.1143.

  PMID: 10937512 BACKGROUND

• Kovatchev BP, Gonder-Frederick LA, Cox DJ, Clarke WL. Evaluating the accuracy of continuous glucose-monitoring sensors: continuous glucose-error grid analysis illustrated by TheraSense Freestyle Navigator data. Diabetes Care. 2004 Aug;27(8):1922-8. doi: 10.2337/diacare.27.8.1922.

  PMID: 15277418 BACKGROUND

• Hybrid closed loop systems for managing blood glucose levels in type 1 diabetes. London: National Institute for Health and Care Excellence (NICE); 2023 Dec 19. No abstract available. Available from http://www.ncbi.nlm.nih.gov/books/NBK613531/

  PMID: 40245209 BACKGROUND

• Gregory GA, Robinson TIG, Linklater SE, Wang F, Colagiuri S, de Beaufort C, Donaghue KC; International Diabetes Federation Diabetes Atlas Type 1 Diabetes in Adults Special Interest Group; Magliano DJ, Maniam J, Orchard TJ, Rai P, Ogle GD. Global incidence, prevalence, and mortality of type 1 diabetes in 2021 with projection to 2040: a modelling study. Lancet Diabetes Endocrinol. 2022 Oct;10(10):741-760. doi: 10.1016/S2213-8587(22)00218-2. Epub 2022 Sep 13.

  PMID: 36113507 BACKGROUND

• Campbell H, Lakens D. Can we disregard the whole model? Omnibus non-inferiority testing for R2 in multi-variable linear regression and etâ2 in ANOVA. Br J Math Stat Psychol. 2021 Feb;74(1):64-89. doi: 10.1111/bmsp.12201. Epub 2020 Feb 13.

  PMID: 32056209 BACKGROUND

• Krutkyte G, Rolfes ED, Herzig D, Guensch DP, Schweizer T, Wuethrich PY, Beldi G, Vogt AP, Bally L. Performance of the DEXCOM G7 CGM system during and after major surgery. Diabetes Obes Metab. 2025 Aug;27(8):4586-4589. doi: 10.1111/dom.16462. Epub 2025 May 21. No abstract available.

  PMID: 40400093 BACKGROUND

• Avari P, Lumb A, Flanagan D, Rayman G, Misra S, Dhatariya K, Choudhary P. Continuous Glucose Monitoring Within Hospital: A Scoping Review and Summary of Guidelines From the Joint British Diabetes Societies for Inpatient Care. J Diabetes Sci Technol. 2023 May;17(3):611-624. doi: 10.1177/19322968221137338. Epub 2022 Nov 28.

  PMID: 36444418 BACKGROUND

MeSH Terms

Conditions

Fever; Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Body Temperature Changes; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• James M Law, PhD, BMBS

  University Hospitals of Derby and Burton NHS Foundation Trust, University of Nottingham

  STUDY DIRECTOR

• James Armstrong, BMBS

  Nottingham University Hospitals NHS Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 13, 2026
• First Posted: May 13, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): February 1, 2027
• Last Updated: May 13, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)