Summary
Implementation of the NICE Technology Appraisal (TA) on hybrid closed loop (HCL) pump therapy requires over 1,500 people with type 1 diabetes to start insulin pump therapy over the next five years in the Leicester area. Monthly large group starts have been implemented using two community halls, and 110 patients have commenced HCL pump therapy since December 2023, using the Omnipod 5 pump. Follow-up has been virtual, using Glooko, supported by the local Omnipod peer support group. Every patient has continued HCL pump therapy with no diabetic emergencies, and substantially improved glycaemic parameters.
Innovation
The NICE TA on HCL pump therapy requires over 300 new adult insulin pump starts per annum in the Leicester area. This is a 10-fold increase on historic starts over each of the next five years. This could not be achieved with a small-group approach at the Diabetes Outpatient Centre, so following a 10-patient pilot in December 2023, monthly sessions have been run since March 2024, with 10 patients in both the morning and afternoon, using two community halls. Staffing usually includes one pump nurse, one dietitian, one consultant and an Omnipod trainer at each session. Ten new insulin pump patients are trained in the morning, and ten pre-existing pump users are upgraded to HCL in the afternoon. Since August 2024, every patient is a new insulin pump patient, with most pre-existing pump users now upgraded to HCL. Ten community sessions are planned per annum, as well as more smaller groups at the Diabetes Centre. Historically insulin pump starts have happened on Mondays, but the new programme is on Tuesdays and Thursdays, to increase capacity overall. Patients are encouraged to join the Leicester Omnipod peer support group.
Equality, Diversity and Variation
Using two community halls has improved accessibility for both patients and staff, with easy parking at both venues and good road access. The Diabetes Outpatient Centre is at Leicester General Hospital in the east of the city, with one community hall in West Leicester (New Parks) and the other in Market Harborough (15 miles south-east of Leicester). GIRFT Feedback from late 2023 suggested patients from more deprived areas of Leicester had less uptake of continuous glucose monitoring (CGM), hence New Parks was chosen, it being in one of the most deprived areas in England. This venue has had 100% attendance, with 60 patients commencing HCL pump therapy. It is now handling HCL pump starts for patients from Hinckley, Coalville and Charnwood. The Market Harborough hall supports HCL pump starts for patients from Harborough, Oakham and Melton, as well as neighbouring villages. The age range is 17-76 years and young people have attended both venues. The team includes two Adolescent DSNs. Almost half the attendees are aged under 30, including young adults with histories of diabetic ketoacidosis and diabetic microvascular complications, including limited vision. Dexcom G6 sensors have been used on four days, and Libre 2+ sensors on two days. The first use of Omnipod 5 pumps with Libre 2+ CGM worldwide occurred in New Parks in early April 2024. Forty patients are on Libre 2+ sensors, with the other 70 on Dexcom G6 CGM. Virtually all patients have stayed on their initial CGM with Omnipod 5 pumps. Overall the community Omnipod 5 HCL pump starts have been accessible and flexible, with students being incorporated through the summer holidays.
Results
Over each of the next five years, 200 HCL pump starts in a community setting are envisaged. People with type 1 diabetes are commencing HCL pump therapy closer to home, taking less than half a day with no additional face-to-face attendances. Being tubeless, the Omnipod 5 pump removes a barrier to pump therapy for many. A simple controller also improves accessibility, as does the option of several locations for the pump (arms, abdomen and thighs). Importantly, this is a safe and effective means, with no diabetic emergencies and every patient remaining on an Omnipod 5 pump in HCL. Patients continue in their usual clinic, and can join the Omnipod peer support group. The website (podding.co.uk) has additional resources, many patients join the WhatsApp group and some attend the monthly face-to-face meetings. Further peer support groups are planned for other pumps. The first large group Omnipod 5 HCL pump start was in December 2023, with monthly starts for 20 patients per day since early March 2024 in New Parks or Market Harborough. In total, 110 patients have commenced Omnipod 5 HCL pump therapy, with no episodes of either severe hypoglycaemia or diabetic ketoacidosis. This has been achieved with virtual follow-up via Glooko, and no formal additional face-to-face follow-up. Most patients have achieved CGM Time in Range of 65-85% and Time below Range at less than 2%, whether using Dexcom G6 or Libre 2+ CGM. While there has been consistent improvement in glycaemic control, there have been substantial weight differences.
User Feedback
The community rollout of HCL pump therapy has been appreciated by patients. The only negative feedback has been a couple of patients wanting face-to-face follow-up, and issues with Libre 2+ connectivity. Having all 110 patients successfully commence Omnipod 5 HCL pump therapy is rewarding for the multidisciplinary pump team.
Dissemination and Sustainability
The community pump starts have substantially increased the HCL insulin pump starts, the key components being days later in the week, virtual follow-up and support from an Omnipod Trainer. Patient selection is important, plus the patient having some technical ability. The administration team is also key, ensuring that the Omnipod kit is available, and CGM with either Dexcom G6 or Libre 2+ is organised. Most specialist pump teams could implement this initiative. The Omnipod 5 pump is the easiest device for a community start. Ensuring that patients are linked up to Glooko at the end of the session is crucial, and a local peer support group is important. Regular MDT pump meetings identify the most suitable patients, and those who would benefit from a smaller group start in the Diabetes Outpatient Centre.
