An observational study in Type 1 Diabetes Mellitis, sponsored by University of Nottingham. Not yet recruiting at 1 site in United Kingdom. Open to participants aged 4 Years and older. Per ClinicalTrials.gov, last updated 2026-05-13.
Sponsored by University of Nottingham · Observational
Among 15 studies in Fever with a site in United Kingdom — 1 open to participants now, 3 under way, 1 of them phase 3. Fever · United Kingdom.
Among the 15 studies in Fever with a site in United Kingdom, this one is the only one that started in 2026, is one of 6 observational ones, and was the 14th registered.
438 studies on the registry are indexed under Fever; 55 are open to participants now.
This study's planned enrollment of 126 is below the median of 408 across 140 observational studies indexed under Fever.
Browse Fever studies →1 of the 15 studies in Fever with a site in United Kingdom is open now, in 1 country. Each count lists the studies.
Of the 38 Fever studies recruiting now, 18 (47%) set no upper age limit and 14 (37%) stop at 75 or younger; 22 take children under 18; 11 take healthy volunteers.
This study: 4 Years and older · all sexes · no healthy volunteers.
The full table on the hub →15 studies; the count open now beside each. This study's row is marked.
First in 1997; this study’s year is marked. 1 started in 2026.
Median enrollment 304 across the 8 interventional studies, 163 across the 6 observational. Of the 8 that completed or were terminated, 6 (75%) have results posted.
6 of 15 have an industry lead sponsor. The 10 most frequent:
University of Nottingham is the lead sponsor of 465 studies on the registry; 80 are open to participants now.
University of Nottingham has 1 study filed under Fever — fewer than ten, so there is no comparison to draw.
2 of the studies in Fever with a site in United Kingdom that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07579390Helsinki University Central HospitalEffects of Sedation, TEmperature and Pressure After Cardiac Arrest and REsuscitation on Major Adverse Kidney Events (STEPCARE-MAKE) | 2026-12 |
| NCT07583238University of NottinghamDiathermy On Diabetes Glucose Monitoring Effectiveness | 2027-02 |
Among the 15 studies in Fever with a site in United Kingdom, from their registry updates:
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:
Background and rationale:
The incidence of type 1 diabetes is rising and technology is an increasingly important part of monitoring and responding to glucose levels. Contemporary monitoring of glucose levels using continuous glucose monitoring (CGM) systems provide users with information about their glucose levels in real time without finger-prick capillary glucose testing. Crucially, these new systems provide information about the trend in blood glucose levels and is now standard in type 1 diabetes. Use of CGM systems is also needed for patients who use "closed loop" systems which adjust insulin at, typically, 5-minute intervals in response to glucose levels. Use of these strategies in glucose level monitoring and management improves long-term outcomes for persons living with diabetes and is now standard of care in type 1 diabetes. Their importance during inpatient admissions and surgery is increasingly recognised but data is limited.
During surgery, diathermy is often used to control bleeding by using high-frequency electrical energy to seal small blood vessels. Available literature supports the hypothesis that CGM systems may not be affected by diathermy, but there is limited information on the actual impact of diathermy on the accuracy of CGM systems. At present, CGM systems warranties are invalidated by diathermy use. Consequently, patients undergoing surgery require a period of blood glucose testing to monitor and respond to glucose levels which are often rendered unstable in the period around surgery. This exposes patients to potentially unnecessary interventions and, for those patients who are needle-phobic or have learning difficulties, the need to renew repeated finger-prick capillary blood testing around surgery may be a significant barrier to effective and optimal glucose monitoring and control. In addition, there may be a delay in responding to hypoglycaemia and hyperglycaemia, due to the time between measurements.
This study aims to assess the impact of intraoperative diathermy use on the accuracy and functioning of CGM systems. Demonstrating that glucose monitoring systems could be effectively used during surgery would:
Study design:
This is a single-centre, prospective, single-arm, observational, non-inferiority study of adults and young people with diabetes using CGM systems. 126 participants will be recruited. Sample size was calculated using simulation.
Participants will undergo paired glucometer and sensor glucose measurements every 15-75 minutes from up to 4 hours before the planned time of surgery until up to 4 hours after the completion of surgery, for not more than 24 hours. They will also have two venous blood samples taken for glucose concentration analysis.
Patient recruitment:
Participants will be recruited from patients due to have an elective surgical procedure at Nottingham University Hospital NHS Trust. The initial approach may be from a member of the patient's usual care team with consent to share contact details with the study team. In addition, the Trust's Theatre Management system (Nervecentre) will be reviewed to identify patients with type 1 diabetes who are due to attend for surgery.
Data management and analysis:
Data will be collected by members of the research team using study specific case report forms (CRFs). An ANOVA mixed effects model will be used with participant as a random effect and pre/post diathermy as a fixed effect. An equivalence F-test with an ARD equivalence value of 0.05 will be performed to determine effect of diathermy on ARD.
Quality assurance plan:
Monitoring of study data shall include confirmation of informed consent; source data verification; data storage and data transfer procedures; local quality control checks and procedures, back-up and disaster recovery of any local databases and validation of data manipulation. Entries on CRFs will be verified by inspection against the source data. A 10% sample of CRFs will be checked on a regular basis for verification of all entries made. In addition, the subsequent capture of the data on the study database will be checked. Where corrections are required, these will carry a full audit trail and justification. Study data and evidence of monitoring and systems audits will be made available for inspection by the REC as required.
Reporting adverse effects:
Intraoperative glucose monitoring is currently undertaken using blood glucose meters. The same monitoring will be continued through this study and this study involves no deviation from standard care. Sensor glucose measurements are passively recorded from the participant's receiving device and eligible participants would already be routinely using sensors as part of their diabetes care.
Equipment failure issues, where a sensor or blood glucose measurement is not able to be obtained, will be recorded on the CRF. Adverse events as a result of participation within this study are not expected but will be recorded on an Adverse Event Form if any occurs. Clinical deterioration and surgical complications, not related to the study, will be considered expected in terms of classification.
Patients aged 4 or older with type 1 diabetes mellitus scheduled to undergo elective surgery at Nottingham Universities Hospitals NHS Trust.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
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).
Time frame: 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 depending on type of diathermy used (bipolar/monopolar).
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. Equivalence is defined as less than a 0.05 difference in ARD.
Time frame: 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).
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. Equivalence is defined as less than a 0.05 difference in ARD.
Time frame: 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).
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. Equivalence is defined as less than a 0.05 difference in ARD.
Time frame: 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.
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. Equivalence is defined as less than a 0.05 difference in ARD.
Time frame: 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).
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. Equivalence is defined as less than a 0.05 difference in ARD.
Time frame: 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 weight (kg).
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. Equivalence is defined as less than a 0.05 difference in ARD.
Time frame: 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 BMI (or BMI SDS in under 18s).
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. Equivalence is defined as less than a 0.05 difference in ARD.
Time frame: 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 sensor accuracy before and after diathermy using error grid analysis.
Error grid analysis will be used to assess the effect of CGM systems accuracy after diathermy use on clinical decision making.
Time frame: 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 the ARD of each system changes after use of diathermy using laboratory glucose concentration results as the reference readings.
The ARD is the absolute difference between the sensor reading (mmol/L) and the reference (laboratory glucose concentration) glucose reading (mmol/L) divided by the reference reading. Equivalence is defined as less than a 0.05 difference in ARD.
Time frame: 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.
Plan to share: No
Start is estimated for May 2026; primary completion for Feb 2027, 9 months later.
Of 51 non-industry observational studies under Fever, half reached primary completion within 22 months of starting (the median), counting those still running; a quarter within 8 and three quarters within 47. This study's planned 9 months is below that.
Counting every sponsor, half of 61 studies reached it within 22 months; a quarter within 8 and three quarters within 36.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Mar 2026. You cannot join it, but the record below documents what was studied.
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