- RAG rating
- n/a
- Document type
- Clinical policy
- Place
- Hertfordshire and West Essex ICB
- Output type
- Clinical Policies & Evidence-based Interventions
- Document
- Download
CamAPS FX in Pregnancy and Very Young Children
January 2024 V1.0
Policy: Interim policy on
CamAPS FX in Pregnancy
A hybrid closed loop system, sometimes referred to as an "artificial pancreas”, links an insulin pump and continuous glucose monitor (CGM) with a mathematical control algorithm that can calculate and automatically deliver the amount of insulin someone needs based on blood sugar readings. This allows the system to do some of the work to help manage blood sugar levels. Manual input is still needed to alert the system when eating or doing exercise.
A NICE Technology Appraisal (TA954) on hybrid closed loops in type 1 diabetes was published on 19th December 2023. This states that hybrid closed loop systems are recommended as an option for all children and young people, all people who are pregnant or planning a pregnancy, and adults with a HbA1c of 58mmol/mol or more or who have disabling hypoglycaemia, despite best management with a pump or CGM.[1] However, it also states that hybrid closed loop systems are only recommended if procured at a cost-effective price agreed by the companies and NHSE..[1]
ICBs are mandated to comply with the recommendations within 5 years. NHSE will develop a 5-year national strategy on the phased uptake approach, which will concentrate on those most likely to benefit and where demand is highest, including children and young people, pregnant (or planning a pregnancy) and adults who already use a pump. .[1]
Several commonly used pump and CGM devices are directly compatible as a hybrid closed loop. Some other devices are only compatible with an additional app to provide the algorithm that calculates insulin doses. CamAPS FX is an Android app that functions as a control algorithm, allowing compatible pumps and CGM devices to function as a hybrid closed loop system. CamAPS FX is the only control algorithm currently licenced in pregnancy and for children aged 1 to 2 years old.
The National Pregnancy in Diabetes Audit has demonstrated that women with Type 1 and Type 2 diabetes have persistently high perinatal mortality, 4-5 times higher than the background population, with no improvement over the past 5 years. The 2022 MBRRACE-UK maternal confidential enquiry illustrated the risks to both diabetic pregnant women and their babies of poorly managed diabetic ketoacidosis. Pre-existing diabetes has been identified as the most significant modifiable risk factor for poor pregnancy outcomes and therefore has been added as a new section to the third version of the national Saving Babies’ Lives Care Bundle (June 2023). NHSE has also identified patients who are pregnant or planning a pregnancy as a priority group for the phased roll out of the NICE TA on hybrid closed loop.
Local Context
HWEICB does not currently have a policy on hybrid closed loop and is awaiting publication of the NICE TA on hybrid closed loop and supporting implementation documents.
Whilst HWEICB does not have a hybrid closed loop policy, our existing CGM policy and criteria for pump therapy enables patients with type 1 diabetes who are eligible for both a pump and CGM to access hybrid closed loop systems. To do this, the clinician requests a pump and CGM device that are directly compatible as a hybrid closed loop, without needing a separate computer algorithm. Our CGM policy supports the use of higher-cost CGM devices where this is to enable hybrid closed loop systems for patients on a pump.
However, as the only hybrid closed loop control algorithm currently licenced in pregnancy and for children aged 1-2 years old is CamAPS FX, pregnant women and very young children cannot access hybrid closed loop using only the pump and CGM devices that are available to others in HWE with type 1 diabetes.
This interim policy aims to address this inequity, ensuring that children aged 1-2 years old and pregnant women with type 1 diabetes have the same access to hybrid closed loop as others with type 1 diabetes.
Interim position
HWEICB will fund CamAPS FX for patients who:
-Are pregnant OR aged 1-2 years old
AND
-Have type 1 diabetes
AND
-Are eligible for CGM
AND
-Are eligible for an insulin pump
AND
- Where the clinical team recommend a hybrid closed loop system.
This policy will be reviewed as part of a wider review of hybrid closed loop technology, following the final publication of the NICE TA and NHSE 5-year national strategy outlining the phased uptake approach.
Patients who are not eligible for treatment under this policy may be considered on an individual basis where their GP or consultant believes exceptional circumstances exist that warrant deviation from the rule of this policy. Individual cases will be reviewed as per the ICB IFR policy.
Change History:
|
Version |
Date |
Reviewer(s) |
Revision Description |
|
1.0 |
December 2024 |
S. Chepkin |
Page 4. Background text updated after Clinical Policy Group on 12th Dec 2023 and before ratification at Commissioning Committee on 9th Jan 2024 to reflect the publication of NICE TA943 on 19 Dec 2023. |
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