Clinical safety and regulatory information

Low Carb Program is a world-leading behavioural change platform that is used to self-manage physical and mental health and wellbeing. The app is a Medical Device (Class I) in the UK and Europe with CE mark. Our MHRA number is 8939.

The app and its contents has been co-developed with people with obesity, prediabetes, type 2 diabetes, hypertension, COPD, NAFLD, and PCOS; behavioural change experts (led by Charlotte Summers), clinicians and healthcare professionals (including from University of Warwick, Royal College of GPs, British Psychological Society, British Dietitians Association) to ensure it meets the needs of service users. The contents of the app have been approved by QISMET for the provision of self-management structured education (QIS 2020 and SS2Q).

The app uses behavioural change techniques (such as goal setting, re-appraisal, human counselling and peer support) to encourage and reinforce particular behaviours. You can read more about the architecture and behavioural change techniques used within this platform: Novel Digital Architecture of a "Low Carb Program" for Initiating and Maintaining Long-Term Sustainable Health-Promoting Behavior Change.

Intended use

Low Carb Program is used to support weight loss in adults diagnosed with:

• Overweight
• Obesity
• Pre-diabetes
• Type 2 diabetes
• Polycystic ovarian syndrome
• Non-alcoholic fatty liver disease

Evidence of the app's use, benefits and evidence-base

We are committed to clinical excellence. Our evidence-based platform is continuously evaluated, including by academic partners, to evaluate the use and benefits of the intervention. Low Carb Program provides multi-platform access to remotely monitored (where delivered by clinical teams) behavioural change support supporting people to maintain a sustainable, healthy weight. The app delivers therapeutic care in areas including weight management, hypertension, and cardiovascular disease.

There are 5 peer-reviewed, published studies evidencing the use of the Low Carb Program.

The Low Carb Program for people with Type 2 diabetes and pre-diabetes – a mixed-methods feasibility study of signposting from general practice

This research study in collaboration with the University of Warwick looked at the opportunistic signposting of the Low Carb Program to patients with prediabetes and type 2 diabetes in NHS general practice.

The study involved 351 patients across 4 NHS general practices in the West Midlands. Researchers found:

• Signposting to the Low Carb Program can take place in a minute
• Follow-up appointments to review medication took up-to 10 minutes
• High acceptability among patients (including those from ethnic minorities) and healthcare professionals
• Average 7.2kg weight loss and 9mmol/mol HbAc reduction for patients completing the program at 7 month follow-up

This research study was published in BJGP Open.

Outcomes of a Digitally Delivered Low-Carbohydrate Type 2 Diabetes Self - Management Program

The study, conducted in collaboration with the University of Michigan, followed 1,000 participants for 1 year. Research demonstrated that participants with type 2 diabetes who completed the Low Carb Program:

• Lost an average of 7% of their body weight
• Reduced HbA1c by 1.2% or 13 mmol/mol
• 54% of people who start on a diabetes medication reduced or eliminated it

People with prediabetes who complete the Low Carb Program lose an average of 8kg at 1 year.

People diagnosed with obesity only lose an average of 4kg at 1 year.

This research study was published in JMIR Diabetes.

Evaluation of the Low Carb Program for the Self-Management of Type 2 Diabetes and Prediabetes in an NHS England General Practice

This research study reported the outcomes of 45 people diagnosed with type 2 diabetes or prediabetes who started the Low Carb Program. All participants finished at least 40% of the program’s modules, and 71% of participants completed the program which was defined as completing at least 9 of the program’s 12 core modules.

At 12 months, participants with type 2 diabetes who completed the program reported:

• An average HbA1c reduction of 7 mmol/mol
• An average 3.66% body weight loss (-3.54kg) at 12 months

At 12 months, participants with prediabetes who completed the program reported:

• An average HbA1c reduction of 3 mmol/mol
• An average 4.57% body weight loss (-4.08kg) at 12 months

This research study was published in JMIR Diabetes.

Low Carb Program Health App Within a Hospital-Based Obesity Setting Observational Service Evaluation

COVID disrupted normal service and face-to-face appointments at University Hospitals Coventry and Warwickshire (UHCW) NHS Trust were replaced with remote care for a period of time - which consisted of the Low Carb Program app and clinical follow-up.

Researchers found that the Low Carb Program was a feasible remote delivery method of obesity care and as effective as traditional, face-to-face obesity management.

This research study was published in Formative JMIR.

Economic Impact Evaluation Case Study: Low Carb Program, York Health Economics Consortium

An average of £117.57 per patient, per year is saved in reduced medication. An economic analysis of the Low Carb Program shows a cohort of 3,000 NHS patients using the Low Carb Program can save £955,614 in reduced medication and HbA1c over 5 years for the CCG.

Contraindications (who should not use the app)

Please speak to a healthcare professional before starting any change to your lifestyle. Please do not use the app if you have any of the following, unless at the referral/request of your healthcare professional:

• Pregnancy or breastfeeding
• History of eating disorders
• Severe mental illness or cognitive impairment
• Porphyria
• Carnitine deficiency (primary), carnitine palmitoyltransferase (CPT) I or II deficiency, Carnitine translocase deficiency, beta-oxidation defects, medium-chain acyl dehydrogenase deficiency (MCAD), long-chain acyl dehydrogenase deficiency (LCAD), short-chain acyl dehydrogenase deficiency (SCAD), long-chain 3-hydroxyacyl-CoA deficiency, medium-chain 3-hydroxyacyl-CoA deficiency, pyruvate carboxylase deficiency

Clinical and technical safety

We are committed to clinical and technical excellence. DDM’s services are delivered in compliance with clinical safety requirements: NHS Data Security & Protection Toolkit, DSCN 14/2009, DCB0129 and DCB0160. Effective application of clinical risk management, clinical risk and safety is managed by the DDM's Clinical Safety Officer, an appropriate, practicing physician skilled and experienced to provide safety and governance. All clinical guidance and references within the platform are aligned to National Institution for Health and Care Excellence (NICE) and/or nationally accepted guidelines. Citations for all claims are available on request.

The app has been evaluated, approved and validated by the Clinical Team, led by the Clinical Safety Officer.

The Clinical Safety Officer for this intervention is Dr Peter Foley. The Caldicott Guardian is Michaela de la Fosse. The Data Protection Officer is Amar Singh. All can be contacted here.

Communications and peer support

All peer-to-peer communications (community, 1-to-1 coaching, comments) are moderated to ensure a safe, inclusive, 24/7 peer-to-peer community. A team of 5 human operators are moderators of the forum. There are also algorithms/filters to prevent spam and/or offensive content. All communications within the platform are logged at event level and audited weekly. Some posts may be removed or hidden to ensure continuity of the service.

Risk and hazard management process

DDM is committed to clinical and technical safety. As ISO27001, ISO9000 and ISO20000 accredited providers, DDM has embedded management and clinical risk systems in place to ensure the technical security, clinical safety and quality of its systems and the data within it.

All data collected, processed and stored is done so utilising AES-256 encryption in-transit and at-rest in the country of participant signup. The transfer of data is via network only Transfer Layer Security (TLS) 1.2 only. This includes the transmission of data from DDM services to its hosts (Microsoft Azure). Remote access to infrastructure holding data is monitored on a daily basis.

DDM has a clinical risk measurement, evaluation and management process overseen by the Clinical Safety Officer. The risk/hazard assessment process follows DDM’s standard Clinical Risk Management System approach. Risks may also be identified in other ways during the development and use of the Low Carb Program such as discovery during design of a solution by supplier or NHS Organisation; participant engagement; feedback; in-app message; testing of amended functionality; ad-hoc testing of live service functionality; reporting of an incident or problem within the live service; and identification by a member of staff within the supplier or NHS Organisation. A full Hazard Log is maintained and updated by the Clinical Safety Team.

For each identified hazard, the following information will be defined and recorded as: hazard number; name and description; potential clinical impact, possible causes and existing controls – these are identified existing controls or measures that are currently in place and will remain in place post implementation that provide mitigation again the hazard, i.e. will be used as part of the initial Hazard Risk Assessment. Each Hazard is reviewed by the Clinical Safety Team and appropriate stakeholders to estimate and evaluate clinical risk and controls, and record the outcome. For each identified hazard, estimation is made of the clinical risk. The estimation process follows that established by the safety processes defined in SCCI 0129. All and any apps and/or products belonging to third parties that are included within a release must be assessed thoroughly.

DDM continually monitors its services. The contents of the app are reviewed every month by the Clinical Safety Team, or as peer-reviewed evidence emerges. In-app telemetry and feedback sent to our support team (in-app or on the web) helps us to identify and address inequities and inequalities in engagement and/or health outcomes.

If you would like to raise a risk or hazard, please contact us.

Risks associated with the app

DDM has conducted several studies and continues to research the evidence-base, benefits and risks.

Please consult your doctor before using this app. The app is not intended to replace the relationship with your doctor/physician. Follow the advice of your doctor.

Unless you have been referred to the app by a qualified healthcare professional, do not use the app if you are diagnosed with any of the conditions listed under Contraindications.

Risks associated with the app for participants with type 2 diabetes taking medications are hypoglycemia and tiredness. People with hypertension (high blood pressure) taking hypertensive medications may experience dizziness. Do not use the app if you are at risk of problems resulting from changes to your diet or activity. Risks reported by participants with polycystic ovarian syndrome are pregnancy. Stop using the app and consult a doctor if you become pregnant.

Blue light from phones and tablets can cause eye strain and speed up blindness. It's also not advised to stare at your phone in the dark. Try not to use your phone before bed. The blue light emitted by your phone can affect the production of the hormone which controls your sleep-wake cycle, or circadian rhythm. This can disrupt your sleep.

Be aware that by using a mobile phone and holding it consistently in your hand, and when moving the thumb rapidly over the keypad can put a great deal of strain on tendons in the arm and cause repetitive strain injury (RSI).