HOME BLOOD GLUCOSE MONITORING IN TYPE 1 DIABETES MELLITUS 1

Objective: To determine which of two simplified blood glucose monitoring schemes promotes better metabolic control in type1 diabetic patients during 12 months of participation in educational groups. Methods: A crossover clinical trial involving 21 patients divided into two groups was conducted. They were submitted to a two monitoring schemes:2 alternate daily preprandial measurements and 2 alternate daily pre-and postprandial measurements. The effectiveness of the schemes was evaluated based on HbA1c. Variations in mean HbA1c were analyzed by Friedman test. Results: The groups were homogenous in terms of sociodemographic and clinical variables (p>0.05). Mean HbA1c levels ranged from 8.48 (±1.00) to 7.37 (±0.99) over time in Group A and from 9.89 (±0.86) to 8.34 (±1.06) in Group B. The analysis of the HbA1c showed a significant reduction in the first and last 6 months and over the 12 months of the study in two groups (p<0.05). The preprandial scheme demonstrated the largest number and highest percentage of significant drops in HbA1c. Conclusions: The two monitoring improved the metabolic control and the preprandial scheme was more effective.


INTRODUCTION
One of the most significant studies to test the proposal that complications of Type 1 Diabetes Mellitus (DM1) are related to a chronic increase in blood glucose was the Diabetes Control and Complications Trial (DCCT) (1) .The DCCT showed that intensive insulin therapy to maintain glucose levels close to normal is certainly effective in minimizing the development and progression of complications of DM (1) .Association (2) .

RESULTS
The characteristics of groups A and B are shown in Table 1.The Mann-Whitney test confirmed the homogeneity of the sample in terms of HbA1c levels at baseline (p=0.548).These values were used as a control parameter for the subsequent analyses.With respect to the glycemic profiles, mean pre-and postprandial glycemic levels and glycemic variation were higher than desired in the two groups over time and no significant difference was observed over time in either group or between periods (nonparametric Friedman test, p>0.05).

Analysis of the variation in HbA1c
concentration over time by the Friedman test showed a significant difference in the first (p=0.0004)and last 6 months (p=0.002) and along the 12 months (p<0.001) of the study in group A, and a significant difference in the first (p=0.028)and last 6 months (p=0.006) and along the 12 months (p=0.002) of the study in group B, irrespective of the current scheme.Tables 4 and 5 4).When changing from Scheme 2 to Scheme 1, the comparisons showed seven declines, two of them significant, and two nonsignificant increases (Table 5).
been raised regarding the difficulties in implementing the rigid controls recommended by the DCCT and also regarding their implications in clinical practice, educational programs, self-monitoring, quality of life and treatment costs, especially at services where no resources or trained professionals are available.Alternative strategies for the control of DM that take into account individual limitations and deficits in the health system related to human and financial resources are necessary and are the main objective of the present study.The objective of the present study was to evaluate the effectiveness of two different home blood glucose monitoring schemes in improving glucose control in patients with DM1 undergoing a monthly therapeutic adjustment regimen over a period of 12 months of participation in educational groups.
and postprandial times (90 to 120 min after meals) and at 3 am every 2 weeks over a period of 6 months.The effectiveness of the monitoring schemes in promoting metabolic control was evaluated by the measurement of glycated hemoglobin (HbA1c) concentration and the results obtained during 12 months were compared to baseline values (November 2003).The patients and their caregivers participated in monthly educational group meetings with the multi-professional team.The meetings of groups A and B were held on different days.The insulin regimens used consisted of 2 to 4 daily applications (before breakfast, before lunch, before dinner, and at bedtime) of intermediate-acting (NPH) and ultrarapid-acting insulin (Lispro).Lispro insulin was applied 15 min before meals.In order to create objective criteria for the therapeutic adjustment of insulin, one week of intensive monitoring consisting of 8 daily pre-and postprandial measurements (run in) was performed at the beginning of the study to determine factors indicating insulin sensitivity and to calculate correction factors to be applied during the study when the number of glucose tests was reduced to twice a day.The same scheme was repeated at the time of inversion of the groups as wash-out.The project was approved by the Ethics Committee of HC-FMUSP (process No.521/01).The data of this study were collected using seven different instruments containing data regarding identification, socio-demographic and clinical variables, insulin treatment regimen and adjustments, capillary blood glucose levels, daily problems, glucose profile, anthropometric measurements, and dietary record.Blood was collected from patients of groups A and B for the measurement of HbA1c (HPLC, normal range: 4.1 to 6.5%) before (baseline values) and 2, 4, 6, 8, 10 and 12 months after the beginning of the study.As a control parameter, all patients had their HbA1c levels compared to baseline values.The patients were instructed regarding the correct technique for capillary blood glucose testing.Finger punctures were performed with Soft Touch Lancets and Advantage System strips were used for glucose testing (both from Boehringer Mannheim Corporation).The quality of the glucose measurements was determined according to the recommendations of the American Diabetes level and housing conditions.Along the study, all other analyses consisted of the interpretation of intragroup data.The nonparametric Friedman test was applied to study the variation in HbA1c and mean glucose levels between the different periods and over time.These analyses were performed separately for each group during the course of the two schemes.When a significant difference in HbA1c concentration was detected, Bonferroni multiple comparisons were performed to identify between which two months the difference occurred.The Wilcoxon test was used for intragroup comparisons of two schemes.
Scheme 2 also showed three nonsignificant increases and nine declines, one of them significant.Interscheme comparisons revealed six increases, two of them significant and three declines, one of them significant when changing from Scheme 1 to Scheme 2 (Table Home blood glucose monitoring… Grossi SAA, Lottenberg SA, Lottenberg AM, Manna TD, Kuperman H. Rev Latino-am Enfermagem 2009 março-abril; 17(2):194-200 www.eerp.usp.br/rlaeThedata were analyzed under the supervision of a statistician, using SPSS for Windows, version 10.0.

Table 1 -
Characteristics of groups A and B

Table 2 .
Variation in HbA1c concentration over time
#baseline; *scheme 2; ** scheme1; Friedman test: p=0.002A significant decline in mean HbA1c levels over time was also observed in group B.

Table 4 .
Multiple comparisons of mean HbA1c in group A * Statistically significant; ** Change from Scheme 1 to Scheme 2

Table 5 .
Multiple comparisons of mean HbA1c in group B * Statistically significant; ** Change from Scheme 2 to Scheme 1