Type 2 diabetes and cancer Nutritional, Metabolic, Endocrine
Conditions
Interventions
Individuals with type 2 diabetes who are planned to receive chemotherapy as part of the treatment for lung, breast or colorectal cancer will be identified by the oncology team and given details about
Sponsors
University of Leeds
Eligibility
Sex/Gender
All
Age
18 Years to 100 Years
Inclusion criteria
Inclusion criteria: 1. Aged >=18 years at the time of cancer diagnosis 2. Biopsy-confirmed cancer of the colon, rectum, breast or lung. High-grade dysplasia is acceptable with unequivocal radiological evidence of invasive cancer 3. Prior diagnosis of type 2 diabetes (T2D) recorded in primary or secondary care (diet-controlled or requiring hypoglycaemic therapies [including insulin]) 4. Cancer care being undertaken at, or managed by, the Leeds Teaching Hospitals NHS Trust, Calderdale and Huddersfield NHS Foundation Trust, Hull University Teaching Hospitals NHS Trust or Sheffield Teaching Hospitals NHS Foundation Trust 5. Planned treatment for cancer includes chemotherapy
Exclusion criteria
Exclusion criteria: 1. Diabetes mellitus diagnosed during the course of active cancer treatment 2. Any diabetes other than T2D 3. Already using the FreeStyle Libre device 4. Inability to give informed consent 5. Known sensitivity to medical adhesives likely to result in an adverse reaction to the Libre device 6. Deemed not suitable for inclusion by study investigators 7. Previous treatment with chemotherapy within 6 months 8. Have a pacemaker or any other neurostimulator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Completion of planned chemotherapy treatment is calculated from instances of dose reduction, early termination of planned treatment and pause in planned treatment at days 14, 21, 28, 90 and 180 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Infection-related outcomes measured using a count of instances of febrile neutropenia, bacteraemia, sepsis, urinary infection, line-related infections, surgical wound infections and sensor-related infections at days 14, 21, 28, 90 and 180 2. Glycaemic outcomes measured using HbA1c at baseline, days 90 and 180, time in range, eHbA1c, hypoglycaemia (h/day), and glycaemic variability (CoV) and hyperglycaemia (h/day) at days 14, 21, 28, 90 and 180 3. Unplanned admissions to hospital measured using a count of emergency admissions to hospital, lasting =24 hours, over the 6-month period following study enrolment 4. Death measured using reports of death within 6 months from study enrolment 5. Patient-reported quality of life measured using EORTC Core Quality of Life questionnaire (EORTC QLQ-C30), EQ-5D-5L, Glucose Monitoring Experiences Questionnaire (GME-Q), Diabetes Self-Management Questionnaire (DSMQ) and Brief Illness Perception Questionnaire (B-IPQ) at baseline, days 14, 28, 180 and 365 6. Cost-effectiveness measured using UKCC at baseline, days 28 and 180 | — |
Countries
England, United Kingdom
Contacts
Public ContactRebecca Birch
Outcome results
None listed