Digital diabetes management is an app that reads a person's blood sugar, blood pressure and daily habits, and suggests what to do next, through an AI coach. It is used for type 2 diabetes, and often also for high blood pressure and weight. Some of these apps only give advice on habits. Others suggest a change to a medicine dose, and those are regulated as medical devices.
The app collects readings from several places. A Bluetooth glucose meter, the finger-prick device that many people with diabetes already own, sends each reading to the phone. A continuous glucose monitor (CGM) sends a reading every few minutes. A blood pressure cuff and the phone's step counter add their numbers. The person types in, or photographs, what they eat and when they take their tablets.
The AI coach reads all of this together. Consider a 56-year-old shop owner in Ahmedabad with type 2 diabetes and high blood pressure. For three mornings in a row, his fasting blood sugar is above 160 mg/dL. The app notices that on each of those days he ate dinner after 10 p.m. It sends him a message suggesting an earlier dinner and a 15-minute walk after it. When his blood pressure reads 150/95 twice in one week, the app reminds him to take his tablet and flags the readings. A human coach, often a nurse or a dietitian, goes through the flagged cases every day and calls him when needed.
Every three months, the app prepares a summary for his doctor. It shows his average readings, the days that went wrong and how often he took his medicine. Some apps send this summary straight into the clinic's electronic health record; others give the patient a report to show. So the ten-minute visit starts from three months of data instead of one blood test. Insurers and hospitals that look after many patients can also receive the flagged cases in their care management software.
In the United States, one such app has been cleared by the American regulator, the FDA, to suggest insulin doses for the doctor to approve. A feature like that makes the app software as a medical device (SaMD). In India, the Central Drugs Standard Control Organisation (CDSCO) regulates medical devices, including software of this kind.
How is this different from a CGM-based diabetes reversal programme? A reversal programme is a shorter course built around a glucose sensor and a coach, with the aim of putting diabetes into remission. A diabetes management app is for everyday care, for as long as the person has the condition, with or without a CGM.