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PRECISION DIABETES IN INDIA – WHERE ARE WE?

DR.V. MOHAN, M.D., FRCP (London, Edinburgh, Glasgow & Ireland), Ph.D., D.Sc.

D.Sc (Hon. Causa), FNASc, FASc, FNA, FACE, FACP, FTWAS, MACP, FRSE

Chairman & Chief of Diabetology,

Dr. Mohan’s Diabetes Specialities Centre & Madras Diabetes Research Foundation,

Chennai, India

Email : drmohans@diabetes.ind.in, Websites : www.mdrf.in & www.drmohans.com

Precision Diabetes includes precision diagnosis, prevention and treatment. Although Precision Diabetes is applicable to all forms of diabetes. Currently, it is more used in type 2 diabetes and Monogenic Diabetes in India.

PRECISION MEDICINE IN TYPE 2 DIABETES

Type 2 diabetes (T2D), is caused by impairment in both insulin secretion and insulin action. Till recently, T2D was considered and treated as one condition. After the work of Alquist et from Sweden describing different clusters of T2D, we also attempted clusters of T2D using clustering. We described 4 clusters of T2D which includes SIDD (Severe Insulin Deficient Diabetes) and MARD (Mild Age-Related Diabetes), which are similar to the Swedish clusters and two new clusters namely IROD (Insulin Resistant Obese Diabetes) and CIRDD (Combined Insulin Resistant and Deficient Diabetes). Insulin secretagogues would obviously be preferred for SIDD and insulin sensitizers for IROD and both groups of drugs for the combined types while MARD is the easiest to treat as it is the mildest variety. An RCT on different drugs to treat these T2D subtypes is currently in progress.

PRECISION DIABETES IN MONOGENIC DIABETES

In the case of monogenic diseases such as Maturity Onset Diabetes of Young (MODY) and Neonatal Diabetes, genetic testing has now come to the realm of clinical practice as these are single gene defects which can be easily identified by genetic testing. Our centre is an ICMR Nodal Centre for India for monogenic diabetes testing (www. http://monogenicdiabetes.in/)

Based on genetic testing, MODY is a group of clinically heterogeneous forms of beta cell dysfunction that are defined at the molecular genetic level by mutations in different genes (eg., HNF4A, GCK, HNF1A, HNF1B, etc). By correctly identifying MODY subtypes like HNF1A & HNF4A, it is possible to avoid life long insulin injections in these patients who are wrongly diagnosed to have type 1 diabetes.

One of the most gratifying clinical applications of Precision Diabetes is in the diagnosis of Neonatal Diabetes which is defined as diabetes occurring in the first 6 months of life. Several children with neonatal diabetes in India carrying the KCNJ11 and ABCC8 mutations have been successfully switched over from insulin therapy to oral sulfonylurea.

In conclusion, precision medicine has finally come to the diabetes clinic. Good clinical phenotyping can make genetic testing cost effective. It can also help change the therapy from life long insulin injections to tablets for some forms of diabetes like monogenic diabetes which can be very gratifying to the patient and his / her family.

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During the Covid pandemic, telemedicine(TM) has been more and more accepted by doctors and patients all over the world. Evidence-based research has found telemedicine-based management of type 1 diabetes efficient in delivering equivalent or better care and outcomes when compared to only face to face visits. A year before the covid, Kerala, the most literate state in India, with 96.2% literacy rate, had a community consisting of parents and children with type 1 diabetes. Almost all these parents had access to WhatsApp and were part of the type 1 diabetes community in Whatsapp. This of course doesn't include all of those with type 1 diabetes in the state but included most of those who were economically compromised and didn't have access to the premier hospitals and doctors.

There were total of 4 WhatsApp groups, each consisting of 250 parents and children from all over the state of Kerala, receiving treatment from government hospitals or other private hospitals. The groups also included volunteering doctors, nurses, educators and dietitians where we were also part. Our duty was to give them directions and advices rather than to treat them. We in addition, provided the economically disadvantaged families with free supplies including insulin, glucometers, strips and injection needles based on their needs. All the communications in the group were based on updated telemedicine guidelines in India.

As a team, we have been providing 24/7 advices and services free of cost to the entire community together with multiple online educational programs via the zoom. Some of these programs were with parents and children together and some other programs incorporated only parents so that counselling can be given to them to specifically address psychosocial issues of these kids.

In each WhatsApp group, one of us in the team, always made sure we replied to the questions posted by the parents or grown up children, without any delay. Most frequently asked questions during Covid pandemic were related to stress and anxiety of children including abnormal/aggressive behaviour, uncontrolled glucose, reluctance with insulin injections and glucose monitoring. We also had to arrange exclusive counseling sessions with psychologist to address the multiple emotional issues of the kids/caregivers. We also created educational videos addressing different aspects of type 1 diabetes and Covid based on the frequently raised questions and concerns.

MERITS

1. All their concerns are addressed even during the middle of the night.
2. Could avoid multiple episodes of DKA
3. Could successfully avert/treat multiple episodes of life-threatening hypoglycemia
4. Dietitians in the groups could advise on diet, specific to individual requirements
5. Diabetes nurses could retrain parents and children on injection techniques whenever found essential, multiple times
6. Questions on stopping insulin or Complementary and Alternate Medicines(CAM), side effects of insulin where not only answered but also explained via videos.
6. Whoever is in short of glucometer strips or needles could get it from community itself or from us without any delay.

DEMERITS
1. The patients in the WhatsApp groups are getting treated in different hospitals and not by the volunteering doctors and healthcare providers in the Whatsapp groups and hence the medical history and records are not with them.
2. Many a time, the patients with uncontrolled glucose might be on an insulin formulation or regimen not suitable for them but the team would not be able to commend on it.
3. Hundreds of parents will be messaging or calling via WhatsApp privately to doctors. However,due to legal implications, they are not replied to unless it is posted in community group.
4. Though there is no hesitancy for the type 1 diabetes community members to open up about disease in the group, there would be many concerns and questions which cannot be posted in a group.
5. Since it is an open community, whatever communications are exchanged; including lab reports are not secure or confidential.
6. The health care professionals(HCPs) will not get a remuneration and there is no funding for this activity; so those getting involved should volunteer out of their commitment to the society.
8. The HCPs may be under tremendous pressure since the patients will have easy and free access to the health care professional.

The WhatsApp community of type 1 diabetes children and their parents were provided support throughout the day and night by the physicians and allied healthcare professionals in each group. This telemedicine model prevented hospital admissions which was widely appreciated by the patient community and it also reduced the overall cost and burden of treatment. However,this model is not free of demerits which may include the legal implications, the errors and mistakes, which can happen in the process of communication and implementation. This advantageous model may not be applicable in many other health systems.

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The Time in Range (TIR) metrics are now accepted internationally and in India as a means of assessing the entire glycemic movement and glycemic variability. The TIR is measured using predominantly CGM devices and also SMBG (although SMBG does have limitations). Professional CGM systems have been available in India for over a decade with the Libre Pro Flash Glucose monitoring being introduced in India for the first time in 2015.

Despite the availability of the libre freestyle and other real time CGM devices like Guardian Rt in India, their use is limited in comparison with the retrospective, professional cgms due to cost and poor awareness. Though the Indian CGM guidelines recommend routine use of cgm for patients with type 1 DM and those with type 2 DM with potential for hypoglycemia the uptake is still slow. TIR as supplementary to HBA1C is slowly gaining relevance amongst Indian physicians and as the use of this technology is predominantly intermittent where used the assessment of TIR through professional blinded CGM (does not get influenced by change in lifestyle and drug dose like in case of real time CGM use) seems most appropriate in the Indian population context.

An important component of the TIR metrics besides the Time in Target and Time above Target percentage is the Time below Target Range as unrecognized hypoglycemia is one of the biggest drawback and limitation of the current approach towards diabetes management. We have identified significant time spent by patients below range inspite of being in higher hba1c bracket and that is an important indicator for routine assessment of TIR in Indian patients through intermittent professional CGM.