The Impact of Medical Nutritional Therapy on the Efficacy of Premix Insulin in Glycemic Control in Patients with Type 2 Diabetes

Abstract

Background: Medical nutritional therapy (MNT) is a key component in the treatment of Diabetes mellitus (DM). MNT is completely individual and should be present in the treatment of diabetes from the very beginning, continuously with pharmacological therapy, taking into account lifestyle, dietary habits and the type of antidiabetic therapy. Mistakes that are made when planning the diet are the absence of individual adjustment of the diet, which means that the number and time of meals, as well as the amount of UH per meal, is not adjusted to the patients' oral or insulin therapy according to their pharmacokinetics and pharmacodynamics.

Objective: This study investigated the effect of MNT with reduced carbohydrate content (MNT M-ADA) on the efficacy of human and analogue premix insulin in patients with T2DM.

Methods: Subjects were randomized into two groups (human and analog premix insulins), and then each group into two subgroups of 30 subjects each. One subgroup each on therapy with human and analog biphasic insulins was educated about MNT and learned to count UH, and then they applied MNT M-ADA for 24 weeks, unlike the other two subgroups. In this review, we present only the subgroup analysis on human and analog premix insulins that applied MNT M-ADA (200 g UH/day). Efficacy outcomes in the analysis of these subgroups were estimated changes in each subgroup from baseline to end point (week 24) and differences between subgroups at the end of the study in levels of glycated hemoglobin (HbA1c), self-measured glucose values (SMBG) and frequency of hypoglycemia.

Results: Both subgroups of subjects with MNT M-ADA improved glycemic control, which was assessed by improvements in HBA1C, SMBG levels, without an increase in the frequency of hypoglycemia, but at the end of the study there was no statistically significant difference in the mentioned parameters between the subgroups.

Conclusion: The effectiveness of MNT M-ADA in people with T2DM did not depend on the type of insulin, both insulin regimens are effective if the amount of ingested UH is taken into account.

Keywords: Hba1C; biphasic insulins; carbohydrates; medical nutritional therapy.

Figure 1.. Research design

Figure 2.. Mean change from baseline in HBA1C levels in T2D participants with MNT M-ADA Legend: parameters are expressed as mean (standard deviation SD); BHI-biphasic human insulin: BIA – biphasic analog insulins; HbA1c- Glycosylated hemoglobin; M-ADA- Medical nutritional therapy, modified diet according to ADA tables with a reduced dose of carbohydrates; ADA-American Diabetes Association; ●=Independent samples t-test;▲–no significance; ap < 0.05; bp< 0.01; cp < 0.001; ♣=Hba1c: BHI S-ADA basal vs. BHI M-ADA at the end of the study; #= Hba1C: BIA S-ADA basal vs BIA M-ADA at the end of the study; • = Hba1C at the end of the study: BHI M-ADA vs. BIA M-ADA

Figure 3.. Comparison of mean values of self-monitored blood glucose levels (SMBG) between subgroups of human and analogue biphasic insulins after administration of MNT M-ADA. Legend: parameters are expressed as median (range, Q1-Q3 interquartile range); mean value (standard deviation SD); PGN – fasting plasma glucose; M-ADA-Medical nutritional therapy, modified diet according to ADA tables with a reduced dose of carbohydrates; ADA-American Diabetes Association; BIA - biphasic analog insulins; BHI-biphasic human insulins; ◊=Two-Independent-Samples-Test (Mann-Whitney U); ●=Independent samples t-test; ▲–no significance; ap < 0.05; bp< 0.01; cp < 0.001; #=Guk on mother-in-law according to M-ADA:BHI and BIA; ⁑=guk 2h after breakfast according to MADA: BHI and BIA ⁘=guk 2h after lunch according to M-ADA: BHI and BIA; ♣ = guk 2h after dinner according to M-ADA: BHI and BIA; ※= guk at 22h according to M-ADA: BHI and BIA.

Figure 4.. Rate of hypoglycemia. Legend: # P=1, OR=1.08 (95%CI: 0.26, 4.27) *Total hypoglycemia was defined as a plasma glucose level ≤3.9 mmol/l which may or may not be accompanied by symptoms; n-absolute number; BHI - biphasic human insulin: BIA - biphasic insulin analogs; M-ADA- Medical nutritional therapy, modified diet according to ADA tables with a reduced dose of carbohydrates; ADA-American Diabetes Association;