VIMS Journal: July 2016

Original Article

An Observational Study on Evaluation And Management of Type 1 Diabetic Patients Attending a Diabetes Clinic in West Bengal

Dr. Debasish Maji, Dr. Ram Udayan Roy

Summary :
Incidence of type 1 diabetes is very low in India, although a large section of Indian population is suffering from type 2 Diabetes. Perhaps due to that reason, researchers are interested only on type 2 diabetes and therefore epidemiologic as well as other information for type 1 diabetes in Eastern India is not easily available. The present work is an observational study on type 1 diabetics based on their multiple clinic visits. Some data were generated which showed that most of the patients were diagnosed with classical symptoms, their follow up and compliance were related to their socio economic status and majority of them (around 51%) were suffering from microangiopathy. It was also observed that End Stage Renal Disease was responsible for highest no. of deaths among them. Above all, it was interesting to note that a good no. of patients (both males and females) got married, had children and were enjoying a cheerful life.

Keywords :
Type 1 Diabetes, IDDM Epidemiology

Introduction :
Type 1 diabetes is considered largely as a disorder in children and adolescents. It is an immune associated selective destruction of insulin producing pancreatic Beta cells and as a result, exogenous insulin is the only treatment for the patients throughout their lives. Although, India is becoming the diabetic capital of the world very soon and the maximum of the diabetic population is of type 2 whereas the incidence of type 1 diabetes is too low, only 0.1 of 100000 people per year[1]. The global incidence is 1 per 100000[2]. But presently the incidence of Type 1 diabetes (T1DM) is also increasing like type2 diabetes, even though not in the same proportion, but still with a trend of 3-5% increase/year. India has three new cases of T1DM/100,000 children of 0-14 years[3]. Because of this small incidence, maximum research efforts were taken on the diagnostic, therapeutic and management status of type 2 diabetics ignoring the importance of type 1 patients. Sufficient data on the glycemic status, patient compliance and relation with the development of diabetic complications, marital and fertility profile along with the morbidity and mortality status are lacking particularly in Eastern India. In this situation, parents and relatives of type 1 diabetic children became panicky and considered ill luck as their children had been diagnosed as diabetic. They thought that they have lost everything in their lives as would have not been permitted to eat many things, do anything or in one word; their lives would be a RESTRICTED one.

Aims and Objectives :
In this scenario, an observational study on type 1 diabetes mellitus has been aimed to get a true picture of different parameters related to the glycemic status, control pattern, social involvement (marriage) and morbidity and mortality profile of type 1 diabetic patients of Eastern India, particularly West Bengal because almost all the patients attending diabetes clinic of this centre and chosen as participants of the study, have came from different parts of West Bengal.

Study Design :
Longitudinal Observational Study.

Study Population :
Type 1 diabetic patient of either sex or different age groups attending the diabetic clinic for last 10 years.

Sample Size :
As it is an observational and epidemiological study for type 1 diabetic, all such patients who have attended the diabetes clinic in different times have been included in the study with no pre determined sample size. In this way, we recruited 82 participants (subjects) for our study.

Inclusion Criterion :
Type 1 diabetic patient of either sex or age group.

Exclusion Criteria :
No specific exclusion criteria for type 1 diabetic patients.

Materials and Methods:
All type 1 diabetic patients attending the clinic were included in the study. In the first visit, a detailed clinical history was recorded including the age of onset/duration and symptoms at onset of the disease with diet and drug received so far. Any relevant family history and past history of disease, operation and infections were noted. The vital signs like pulse, blood pressure, height and weight were also recorded and whole systemic examinations were done. The relevant past investigation reports were recorded. They were advised to follow the lifestyle modification and necessary insulin regimen as per standard protocol followed by the clinic. In the next visit, they were carefully followed up both clinically and by investigation reports. Their compliance and follow up were carefully monitored. Data obtained from minimum six follow up visits or six years' follow up were taken into account for analysis. The mean values of the numerical variables like Fasting and Post Prandial Plasma Glucose, HbA1C levels etc. obtained from each patient were calculated. A grand total of those values for 82 patients were considered further to generate a mean value. The data expressed as mean ± S.D. The other categorical variables like type of insulin used, social involvement (marriage), fertility, compliance and follow up, morbidity and mortality etc. were expressed in percentage. As this was an observational (non interventional, non comparative) study, no null hypothesis was there and therefore no statistical analysis was performed. The results obtained were compared with some other studies only.

Age(M) Male Female Height(cm) Weight(kg)
16.26yrs ± 6.16 45(54.88%) 37(45.12%) 156.12 ± 11.22 49.6 ± 6.33
FPG (mg/dl) PPPG (mg/dl) HbA1c (%) Age/diag Symptoms at Onset
171.39 ± 13.12 248.65 ± 20.32 9.63 ± 1.02 13.34 yrs ± 2.02 Classic 89% DKA 11%

Results:
Patients reported in the clinic at the age of 10- 26 years with a mean value of 16.26 years. Most of them diagnosed with classic symptoms like polyuria, Polydipsia loss of weight etc (89%) whereas some of them with acute state (Diabetic KetoAcidosis-11%). They were diagnosed at 11-15 years of age with a mean value of 23.34 years. A male preponderance was found among the patients. Desirable control could not be achieved as evidenced from mean HbA1C level.

Monthly, 3 monthly and more than three monthly follow up were considered as good, moderate and poor respectively. Maximum patients fall in the moderate category. During monitoring, patients who were found to be restricted on life style modification and insulin regimen and at least one phone call to the clinic for consultation were categorized as good complied patients. Relaxations in lifestyle and/or insulin regimen for two to three times in a month were considered as moderately complied and beyond that was grouped in poor compliance group. More patients found their place in the moderate group. Their socio economic status was also evaluated using Kuppuswami scale and a direct relationship was found between the socio economic status and the follow up/compliance grading.

Maximum patients were treated with pre mixed (30/70) insulin twice daily. 25% was on Basal- Bolus insulin therapy and only 7% were on other types like Rapid Acting etc.

The marital status and fertility profile of the type 1 diabetic patients are showed here. It has been found that 57.77% of males and 62.16% of females have reached marital age and out of them, 57.69% male and 43.48% females got married. 73.33% males and 50% females have children.

The morbidity and Mortality table showed that over 50% of the patients were suffering from microangiopathy of which, Chronic Kidney Disease (CKD) and Retinopathy together occupied the highest position (30%). 16% of the patient died and again, the cause of death was End Stage Renal Disease in maximum cases (30%) which showed that even a patient was not a known case of kidney disorder, he might be died of renal disease.

Table-2
Good Moderate Poor
Follow up 23% 46% 31%
Compliance 23% 47% 30%
Socio-economic Status 21% 60% 19%

Table-3 :Management of Type 1 Diabetes
Insulin Regimen Followed
Premixed (30/70) Bid 68%
Basal-Bolus 25%
Others 07%

Figure-1

Diabetes Compliance & Socio-eco Status

TYPE – 1 DIABETES Marital status & Fertility Profile

Discussion :
As discussed before, the detailed data about the type 1 diabetic population in Eastern India are not enough till now. Some observations on the incidence and prevalence percentage of type 1 diabetic patients were studied earlier in Cuttack by Samal et. Al. from 1983-88 with 54 patients and then in Kolkata by Mazumder et.al. from 2004-2006 with 41 patients.[4] The present study deals on the status of the type 1 patients while living with diabetes. In our study, we found the age of onset at 11-15 years which closely resembles the findings of other western workers[ 5 - 7 ]. We have found a male preponderance (54.88%) over female (45.12%). One observation suggested the equally affection rate in both the sexes[8], while another systematic review showed that T1D incidence was larger in males than in females in 44 of the 54 (81%) studies reporting incidence by sex in people >15 years of age. The overall mean male-to-female ratio in the review was 1.47[9]. 89% of the patients presented with classical symptoms and 11% with complications like DKA (Diabetic KetoAcidosis) at diagnosis in the present study which was supported by other workers[10]. We have found mean HbA1C level 9.63±1.02 whereas in SEARCH study, they reported a mean HbA1C level 8.2% in youth with type 1 Diabetics with 17% having HbA1C = 9.5%[11].We have observed the patient follow up and compliance level and also analyzed the socio economic status of the patients[12] and found that most patients were within the moderate group as compliance level and follow up status were considered. When compared with socio economic status, it was found that the patients belong to the good socio economic status had good compliance and follow up visits. Same was true in moderate group but percentage of patients in poor complied and follow up group was greater than that in the poor socio economic class. Perhaps some patients though belonged to the good or moderate socio economic category, did not show interest in good compliance and follow up. The socio economically backward patients might find some difficulties in regular consultation, purchase of insulin or glucometer for regular monitoring of blood glucose etc. and therefore their compliance level or follow up visits decreased.

68% of our patients were controlled with pre mixed insulin and here we can also quote other study where pre mix insulin was advised in the treatment guideline for type 1 diabetics although Basal Bolus therapy was also recommended[13]. A morbidity/mortality profile of the type 1 patients was prepared and compared with the observations of Johenson from Denmark, published in 2013. Their median age (44 years vs. 26 years), duration (18 years vs. 11 years) and complications like CKD, Neuropathy, Retinopathy and CAD) were more than those we found but the incidence of death was almost same (14% vs. 16%). Highest cause of death was CKD in our study (30%) whereas it was CAD in the comparator study (31%) the percentage being almost same.

Table-5 Type 1 Diabetes Morbidity/Mortality 10 Years' Follow up
Mediun Age 26 years
Mediun duration 11 years
CKD 15%
Neuropathy 13%
Retinopathy 15%
CAD 8%
Cause of Death 16% (of Cohort)
CAD 7%
Acute complication 7%
ESRD 30
Accidental 7%
Infection 15%
Others 15%

Conclusion :
The observations from the present study come into the following conclusion:
Incidence of Type 1 diabetes is rare in India. There is no specially planned care for this small population of type 1 diabeties particularly in Eastern India and as a result, majority do not get proper healthcare. Poorer people, especially the people living in remote areas have poor diabetic control, poor compliance and therefore, poor outcome including early development of complications and even death. Type 1 diabetic patients need extensive training for proper lifestyle modification, insulin injection technique, use of glucometer and monitoring of their health status from very beginning since detection of the disease. The family members, class teacher in the school employers in the employment area also need proper education so that the patients remain healthier.

References
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  9. Paula A Diaz-Valencia, Pierre Bougnères and Alain- Jacques Valleron. Global Epidemiology of Type 1 Diabetes in young adults and adults: a systemic review. BMC Public Health. 2015; 15:255.

  10. Levy-Marchal C, Patterson CC, Green A. Geographical variation of presentation at diagnosis of type I diabetes in children: the EURODIAB study. European and Dibetes. Diabetol. 2001; 44 (Suppl 3):B75-B80. [PubMed]

  11. Petitti DB, Klingensmith GJ, Bell RA, et al. Glycemic control in youth with diabetes: the SEARCH for diabetes in Youth Study. J Pediatr. 2009; 155:668-672. [PMC free article] [PubMed]

  12. P Dudeja, P Bahuguna, A Singh, N Bhatnagar. Refining a socio-economic status scale for use in community-based health research in India. JPGM 2015; 61(2) : 77-83.

  13. Silverstein J, Klingensmith G, Copeland K, et al. Care of children and adolescents with type 1 diabetes: a statement of the American Diabetes Association. Diab care. 2005;28:186-212. [PubMed]

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