CGMs Add Value in Reversal of T2D but are not Indispensable!

Autobiography of Delayed Weight Reduction and Response

I was diagnosed as diabetic type 2 in mid-1991 in an annual checkup as a part of organizational requirements, by a private physician, that was later confirmed by an endocrinologist in All India Institute of Medical Sciences New Delhi, a national institute of super-specialties. Apart from beginning walking, exercises, and diet control through 3-4 hourly small feeds, I was put on Tab Amaryl (Glimepiride) 2 mg, before and after Lunch and dinner, Tab Glycomet SR (Metformin released over 12 hrs. at a constant rate and the drug action is prolonged) 500 mg after lunch and dinner and Glucobay 50 mg (Acarbose used when diet, exercise, are not enough) before breakfast and evening snacks. No advice of any weight reduction (65 Kgs for a height of 65 inches) since BMI was 23.

I was able to maintain my Hb1Ac around 7% until June 2005, when I had to undergo a coronary artery bypass graft (CABG) for anginal pain while walking about 3 Kms due to triple vessels block. After the surgery my Amaryl dose was increased to 3 mg each time and was asked to take Glycomet SR even after breakfast. I started consultations in Fortis C-DOC Hospital, Delhi the top among Indian Diabetes care institutes from 2014 as my diabetologist had started it. Again until 2017 I was able to maintain my Hb1 Ac around 7% and my Diabetologist was happy. In early 2017 during an annual checkup the Hb1Ac had shot up to 8.8% and my Diabetologist was unhappy and introduced a new drug Gibtulio {(Sodium Glucose Co-transporter-2 Inhibitor drugs (SGLT2) (Empagliflozin)} 10 mg once in the morning, with continuation of all earlier drugs. The Hb1Ac came down after 3 months to around 7%. Having relocated to Bengaluru in 2018, in early 2019 I read a few articles highlighting the value of weight reduction, vegetables, and fruits especially papaya and intermittent fasting. I switched on to Papaya (around 10 g/kg body) fruit as breakfast around 11000 hrs. and intermittent fasting allowing 1100-2100 hrs. as eating window (Table 2).

I used to monitor my Blood sugar using simple glucometers at home, initially with One touch ultra (10 years), Beat O Smart Sugar Testing Machine (1 yr.), for last 2 years with Beat O CURV Glucometer Kit, and Accu-Chek Active Blood Glucose Meter Kit at home. There is nothing much to choose between them. The availability of strips and self-life of the device determined the change. In addition, I get tested on my Hb1Ac in accredited Labs once in 3-4 months.

Since I started weight reduction after 30 years, it took almost 4 years to reach the current weight of 57 Kg and Hb1Ac coming below 7%

Losing weight

The relationship between weight loss and glycemia is very close. One begins to see improvement in glycemic measures and triglycerides with small amounts of weight loss, but with greater levels of weight loss there is even greater improvement. Good news is it takes only small amounts of weight loss to prevent progression to type 2 diabetes from impaired glucose tolerance and after the 10 kg of weight loss one cannot demonstrate much additional improvement in risk reduction or benefit among diabetics [10]. Infact in 1990’s weight reduction was advised only for overweight or obese people (BMI>25). More than BMI it is the waist circumference that matters to assess interstitial aft accumulation, that decide Insulin resistance. A waist of 40 cms for men and 35 Cms for women is the cut off used. Now weight reduction is advised to all soon after diagnosed as Diabetics. Ideally 10-15% of the individual’s body weight is targetted over time (12-15 months). Earlier the weight reduction effort is made it is better for outcomes in terms complications of diabetes and reversal of diabetes as was seen in our first case of Arun. Weight reduction by 10-15% can be attempted through dietary changes, exercises, using medications, or even bariatric surgery if required. In my case I reduced from 65 Kg to 57 kgs over 5 years.

Exercises

Being active makes our body more sensitive to insulin and helps control blood sugar levels apart from reducing the risk of heart disease and nerve damage. Exercise draws on reserve sugar stored in our muscles and liver. To rebuilds these stores, it takes sugar from our blood. The more strenuous your workout, the longer blood sugar will be affected. Sustaining low blood sugar is possible even four to eight hours after exercise. All most all physicians advise diabetics walking as an exercise in India, but very few demonstrate and recommend muscles strengthening. Passive static stretching of the skeletal muscles is a better alternative to exercise to help regulate blood glucose levels in diabetes patients [11]. Start with resistance bands or light dumbbells (1-2 Kgs) so you can focus on lifting and lowering the weights with smooth, controlled movements. When you can do two or three sets easily, switch to slightly heavier weights. Standing Biceps Curl, Triceps extension, shoulder press, Chest press, Seated rowing with stretch bands, classic crunch, Planks, Squats, lunges, hamstring curls, are beneficial in strengthening various muscles and also keep the blood sugar under control. Personally I do it for nearly 6 years now [12, 13] and derived benefit from it.

Monitor blood sugar levels

Monitoring the blood sugar levels at home is more important, once you start working on weight reduction, plan your diet and drugs as required, that helps to fine tune the combinations of the inventions [2, 6, 7].

Glucometers

Glucometer is the need of the hour as our lifestyles continue to become more stressful, and we dwell in habits that are not necessarily too good for our health. While we cannot keep in check all the things essential for our body, blood glucose levels can easily be tracked and maintained using a glucometer. A glucometer is a hand-held instrument with a digital screen that’s used with disposable test strips treated with chemicals that react to glucose. Some glucose meters come with a lancing device. There are at least 10 types of Glucometers in Indian market. All of them are equally good. Initial measurements must evaluate what food and quantity of each food item would rise individual’s BS to what extent and determine the quantity of each common items one can consume at a time. The frequency initially can be once or twice a month and each time 8 readings Fasting, before and after breakfast, before and after Lunch, after evening snacks and before and after dinner. Over the years, they may not be required more than once in 2-3 months and following any infections. Home kits are the cheapest, as initial equipment costs INR 1000 & a strip costs INR 10 each test [6].

Continuous Glucose Monitoring (CGM)

Device CGM sensors are small, unobtrusive, and easily applied to the back of the upper arm. The sensor continuously measures and stores glucose readings when worn on your body, and sensors come with an applicator and use a small, flexible tip that is inserted just under the skin.

With CGM, you can get real-time glucose readings and feedback on glucose levels and trends to make informed diabetes management decisions. Helps in uncovering glucose patterns for a complete picture blood glucose trend, thus help reduce time spent in hypoglycemia, improve overall glucose control, and most importantly know how different activities affect our glucose levels. Optional, real-time glucose alarms get real-time glucose alarms that notify you the minute your glucose is too low or too high. Unsurpassed 14-day accuracy for adults and children [6, 7, 8, 10].

Statistically significant HbA1c reduction based on the confidence interval range was observed at 2-4 months and sustained at month 12 in adults and children with T1D and adults with T2D. In India Continuous Glucose Monitoring (CGM) are manufactured by Abbott Diabetes Care Inc., Dexcom Inc., Medtronic PLC., Eversense., and Ascensia. While an initial cost around 11,000. 00, a Personal sensor for 14 Days costs Rs 2399/box. The FreeStyle Libre 3 system has many improvements compared to the Freestyle Libre 2 and 14-day systems. The sensors are smaller, easier to attach, and they track glucose readings much better, and devices are more convenient to use and to cost the same [5] (Figure 1).

A randomized clinical trial conducted at 15 centers in the US (July 30, 2018, to October 30, 2019; follow-up completed July 7, 2020) among 175 randomized participants (mean age, 57 [ SD-9] years; 88 women [50%]; 92 racial/ ethnic minority individuals [53%]; mean [SD] baseline HbA1c level, 9.1% [0.9%]), 165 (94%) completed the trial. Mean HbA1c level decreased from 9.1% at baseline to 8.0% at 8 months in the CGM group and from 9.0% to 8.4% in the BGM group (adjusted difference, -0.4%. In the CGM group, compared with the BGM group, the mean percentage of CGM- measured time in the target glucose range of 70 to 180 mg/ dL was 59% vs 43% (adjusted difference, 15% P < .001), the mean percentage of time at greater than 250 mg/dL was 11% vs 27% (adjusted difference, -16% P < .001), and the means of the mean glucose values were 179 mg/dL vs 206

mg/dL (adjusted difference, -26 mg/dL P < .001). Severe hypoglycemic events occurred in 1 participant (1%) in the CGM group and in 1 (2%) in the BGM group [14].

Click to enlarge

Type 2 diabetes reversal has been viewed in the literature primarily as a dichotomous event, despite not being optimal for clinicians or patients. A cohort study with objectives of defining stages of type 2 diabetes reversal and measure changes in reversal stages before and after 90 days of digital twin-enabled precision nutrition therapy, compared pre/ post changes of HbA1c, weight, BMI, and nutrition therapy. The results of 463 patients at baseline, the proportions of patients in each reversal stage were Stages 1 and 2: 0%, Stage 3: 1%, Stage 4: 8%, Stage 5: 6%, and Stage 6: 85%. After 90 days, the proportions in each reversal stage were Stage 1: 2%, Stage 2: 9%, Stage 3: 32%, Stage 4: 39%, Stage 5: 7%, and Stage 6: 11%, indicating significant progress. Reversal stage progression rates varied by patient subgroup.

{Reversal stages were defined as Stage 0: HbA1c < 5.7% without medication for > 1 year, Stage 1: HbA1c < 5.7% without medication for < 1 year, Stage 2: HbA1c < 6.5% without medication, Stage 3: estimated HbA1c (eA1c) between 5.7 and 6.4% without medication, Stage 4: estimated HbA1c (eA1c) between 5.7 and 6.4% with metformin monotherapy, Stage 5: dual oral therapy, Stage 6: > = 3 medications}. Though the use of CGMs helped reversal stages during therapy, all did not benefit to same level during

90 days of precision nutrition therapy.

Limitations

i) Among adults with poorly controlled type 2 diabetes treated with basal insulin without prandial insulin, continuous glucose monitoring, as compared with blood glucose meter monitoring, resulted in significantly lower HbA1c levels at 8 months but its use in T2D treated with basal insulin without prandial insulin or oral antidiabetics has not been well studied [7]. ii) For patients who become overwhelmed, the psychological burden of the CGM may be too high in relation to its likely benefits. ii) In view of the cost most Indian diabetics will not be able to afford CGM devices [6, 8].

BS Test through Laboratories

Blood sugar test prices in the laboratories range from Rs 50 to Rs 150 in the laboratories and while using a home test kit can cost as low as Rs 20. The HbA1C- Glycated Hemoglobin test Price in India is around ₹600. Currently this is the most reliable monitoring tool in developing countries to complement the home tests when we monitor using standard glucometers.

Expenditures of managing Diabetes in India: The average total expenditure per patient per month (pppm) is around ₹1,500 to 5000, based the medication prescribed, 80% expenditure on medicines and remaining 20% on nonmedical expenditure. Adding CGM will increase the cost to about INR 5000 per month.

Eat healthily

There’s no one-size-fits-all diabetes diet, so the family physician or the primary care doctor must tailor-make the diet plan for each patient in consultation with the family about normal family pot, resources to change, if need be, common food items available in the community /eaten food taboos if any. Beginning with reducing processed foods and high sugar foods and carbohydrates, slowly expanding to increase protein and fats for deriving requisite calories. Increasing the quantity of vegetables and fruits to make the tummy full is a better approach [14]. A dietician’s service may not be available in most primary and secondary care facilities and the physicians must take over this role. Dedicated diabetes care facilities and tertiary care institutes may have the services of dieticians and they can use it. In my experience majority of nutrition graduates need applied diet planning training- particularly for using the locally available raw items and adaptation of local cooking practices and be equipped for advocating and demonstrating changes only if needed. Try to make up your daily calories requirements- 40% from carbohydrates, 30% from fat and 30% from protein with emphasis on vegetables and fruits to make the volume (bulk) to make the tummy full every time. A big No! No! to processed foods and foods high in sugar. This “magical” mix promises to lower risks for diabetes and heart disease, and cancer. Fruits, Vegetables, and Intermittent fasting [9, 10, 14].

Quit smoking

Quitting smoking improves our body’s usage of insulin. We have known for a long time that people who smoke cigarettes are 30%–40% more likely to develop type 2 diabetes than people who don’t smoke. Nicotine increases blood sugar levels and makes them harder to handle. People with diabetes who smoke are more likely than those who don’t smoke to have trouble with insulin dosing and managing their condition as often they need larger doses of insulin to keep their blood sugar close to their target levels. Research in 2022 revealed that quitting smoking helped in a transitory decrease in type 2 diabetes mellitus patient’s glycemic levels that can continue up to three years [15].

As it makes the patient hungrier the next day, reduces satiety after eating, leading to more eating and a rise in blood sugar [16]. The physiological state at the end of a meal when further eating is inhibited by ‘fullness’ is termed satiety. Satiety, or between-meal satiety, ends as meal processing and absorptive signals wane and hunger initiates the next period of eating [14].

Get enough sleep & address obstructive sleep apnea (OSA)

Sleeping less than 7 hours per night regularly increases insulin resistance.

We all experience the stress of the day’s work and other responsibilities as the reasons for poor sleep. Stress alone doesn’t cause diabetes. But there is some evidence that there may be a link between stress and the risk of type 2 diabetes. Researchers think that high levels of stress hormones might stop insulin-producing cells in the pancreas from working properly and reduce the amount of insulin they make. Diabetics sleeping Less than 7 hours for long find it harder to manage diabetes [17]. Several cross-sectional studies have shown that OSA impairs insulin sensitivity and glucose tolerance, and it has been demonstrated that OSA is independently related to the development of insulin resistance, while the oxygen desaturation index is the main determining factor. OSA has been shown to increase the risk and severity of type 2 diabetes independent of age and obesity. Intermittent hypoxia’s effect on adipose tissue induces insulin resistance. There are limited data on the relationship of OSA to type 1 diabetes and the cardiometabolic impact of OSA in children [18].