scholarly journals Thyroid Hormones, Peripheral White Blood Count, and Dose of Basal Insulin Are Associated with Changes in Nerve Conduction Studies in Adolescents with Type 1 Diabetes

Metabolites ◽  
2021 ◽  
Vol 11 (11) ◽  
pp. 795
Author(s):  
Marta Wysocka-Mincewicz ◽  
Marta Baszyńska-Wilk ◽  
Maria Mazur ◽  
Aleksandra Byczyńska ◽  
Monika Nowacka-Gotowiec
Keyword(s):  
Type 1 Diabetes ◽  
Thyroid Hormones ◽  
Nerve Conduction ◽  
Basal Insulin ◽  
Blood Count ◽  
Demographic Data ◽  
Insulin Dose ◽  
White Blood Count ◽  
Cell Counts

Type 1 diabetes (T1D) in the child population is the third most common chronic disease. Diabetic peripheral neuropathy (DPN) is a very disabling and silently developing complication. This prospective, observational study enrolled 182 (93 girls) patients with T1D, aged 16.5–18 years. The aim of the study was to assess the correlation between factors of diabetes metabolic control, blood count, thyroid hormones, thyroid-stimulating hormone (TSH), level of cortisol, vitamin D3, metabolic factors, demographic data, and nerve conduction study (NCS) parameters. We revealed that in multivariate regression models for almost all NCS parameters, beside height and diabetes duration, significant factors were basal insulin dose per kilogram of weight (BID/kg), body mass index (BMI), and thyroid hormones. For conduction velocities of the motor nerves, mean HbA1c exists in models. In all models for all NCS parameters there exists at least one parameter of peripheral white blood cell counts (predominantly monocytes). There is a significant influence of thyroid hormones, peripheral blood white cells count, and BID per weight on parameters of NCS. It is essential to take care of the proper insulin dose per weight of patients and the adequate proportion of basal to prandial insulin.

scholarly journals Multicenter, Open-Label, 2-Arm, Pilot Trial for Safe Reduction of Basal Insulin Dose Combined with SGLT2 Inhibitor in Type 1 Diabetes Mellitus: Study Protocol for a RISING-STAR Trial

2021 ◽  
Vol 14 ◽  
pp. 117955142110405
Author(s):  
Masahide Hamaguchi ◽  
Yoshitaka Hashimoto ◽  
Toru Tanaka ◽  
Goji Hasegawa ◽  
Michiyo Ishii ◽  
...  
Keyword(s):  
Diabetes Mellitus ◽  
Type 1 Diabetes ◽  
Type 1 Diabetes Mellitus ◽  
Sample Size ◽  
Basal Insulin ◽  
Insulin Dose ◽  
Sglt2 Inhibitor ◽  
Open Label ◽  
Group B

Background: The safe method of instructing insulin dose reduction in combination with SGLT2 inhibitors, dapagliflozin for patients with type 1 diabetes mellitus has not been clarified. In this study, we conducted a stratified, 2-arm, parallel comparative study with the primary endpoint of decreasing the frequency of hypoglycemia by instructing basal insulin dose reduction. Methods: The study has a multicenter, open-label, 2-arm design; 60 type 1 diabetes mellitus patients are being recruited from 7 hospitals. Study subjects have been stratified into 2 groups based on the ratio of basal insulin daily dose (Basal) to total daily insulin dose (TDD). The subjects whose Basal/TDD ratio is <0.4 are instructed not to reduce Basal but to reduce bolus insulin dose by 10% (group A), and subjects with a Basal/TDD ratio >0.4 will be instructed to reduce Basal by 10% (group B). The primary outcome is the daily frequency of hypoglycemia during the intervention period (SGLT2 inhibitor administration), as determined by self-monitoring of blood glucose. We aimed to confirm a greater reduction in frequency of hypoglycemia in group B (reduced Basal), than in group A (non-reduction of Basal and reduced insulin effect levels by 10%). Baseline hypoglycemia was set at 7 ± 6 times/month. The minimum sample size required to achieve a significance of .05 for a 1-sided t-test with a statistical power at 80% is determined. When the sample size is 26 patients in 1 group, the percentage increase in hypoglycemia exceeds 60%, and the sample size is considered sufficient. Discussion: In this pilot study, we assumed that, given a sufficient Basal, hypoglycemia would be more frequent in patients with type 1 diabetes when combined with SGLT2 inhibitors, provided the Basal was not reduced.

scholarly journals Healthy Pregnancy and Birth during Unusually Long-Lasting Remission of Type-1 Diabetes: Case Report

2020 ◽  
Vol 3 (1) ◽  
pp. 1-5
Author(s):  
Fövényi J ◽  
Pánczél P ◽  
Thaisz E
Keyword(s):  
Type 1 Diabetes ◽  
Blood Glucose ◽  
Insulin Glargine ◽  
Basal Insulin ◽  
Insulin Dose ◽  
Challenge Test ◽  
Tolerance Test ◽  
Oral Glucose ◽  
Daily Insulin

The 26-year-old woman was diagnosed with type 1 diabetes in 2014. The diagnosis was confirmed while there was a slight increase in blood glucose and HbA1c levels using oral glucose tolerance test, determination of insulin levels and GADA testing. This was followed by a 2-year period with complete remissions and partial remissions of 2-8 U daily basal insulin glargine. Thereafter, the patient became pregnant. The minimal basal insulin used to date has been switched to human rapid-acting and NPH insulins five times daily, which had to be increased to 11 times the initial dose in the third trimester of pregnancy. After a successful spontaneous birth of a healthy baby girl, our patient wished to return to one-tenth of the maximum insulin dose that was used during pregnancy, to once daily insulin glargine. After three months, her blood glucose levels began to rise, with oral glucose challenge test showing a marked increase in blood glucose and a drastic reduction in C-peptide levels. This was when we switched to multiple daily insulin administration using glargine basal- and glulisine analogue insulins. Later, glargine was switched to insulin degludec, and with a 30-33 U total daily insulin dose and CGM for the past two years, the patient was in a satisfactory metabolic state.

scholarly journals Basal Insulin Dose in Adults with Type 1 Diabetes Mellitus on Insulin Pumps in Real-Life Clinical Practice: A Single-Center Experience

2018 ◽  
Vol 2018 ◽  
pp. 1-5 ◽  
Author(s):  
Bartłomiej Matejko ◽  
Aneta Kukułka ◽  
Beata Kieć-Wilk ◽  
Agnieszka Stąpór ◽  
Tomasz Klupa ◽  
...  
Keyword(s):  
Type 1 Diabetes ◽  
Glycemic Control ◽  
Basal Insulin ◽  
Hba1c Level ◽  
Metabolic Diseases ◽  
Insulin Dose ◽  
Real Life ◽  
Pump Therapy ◽  
Single Center Experience

Introduction. Basal insulin (BI) infusion in pump therapy of type 1 diabetes (T1DM) mimics physiological secretion during the night and between meals. The recommended percentage of the total BI to daily insulin dose (termed the %BI) ranges between 30 and 50%. We analyzed whether this recommendation was followed in adults with T1DM from a university center, and whether BI doses were linked with glycemic control. Materials and Methods. We included 260 consecutive patients with T1DM (159 women and 101 men) treated with continuous subcutaneous insulin infusion at the Department of Metabolic Diseases, Krakow, Poland. Data were downloaded from patients’ pumps and collected from medical records. We analyzed the settings of BI and the association of %BI with HbA1c level. Linear regression was performed. Results. The mean age of T1DM individuals was 26.6 ± 8.2 years, BMI was 23.1 ± 3.0 kg/m2, T1DM duration was 13.3 ± 6.4 years, and HbA1c level was 7.4%. There were 69.6% (n=181) of T1DM patients with %BI in the recommended range. The T1DM duration and HbA1c level of patients with a %BI <30% (n=23) was 9.5 years and 6.4%, respectively; for a %BI of 30–50%, it was 13.2 years and 7.4%; and for a %BI >50% (n=56), it was 15.8 years and 7.8% (p<0.001 for both three-group comparisons). Multiple regression identified %BI among independent predictors of the HbA1c level. Conclusion. In this real-life analysis, the recommendations concerning %BI dosing were not followed by almost one-third of adult T1DM patients. Low %BI was associated with better glycemic control; however, this requires further confirmation.

scholarly journals Insulin Basal Dose Is Associated With Better Metabolic Control in Type 1 Diabetes Children and Adolescents

2021 ◽  
Vol 5 (Supplement_1) ◽  
pp. A660-A660
Author(s):  
Abril Arellano-Llamas ◽  
Luz Elena Mejía-Carmona ◽  
Alicia Rojas-Zacarias ◽  
Oscar Ochoa-Romero ◽  
Irene Díaz-Rodríguez
Keyword(s):  
Type 1 Diabetes ◽  
Metabolic Control ◽  
Basal Insulin ◽  
Glycated Hemoglobin ◽  
Insulin Dose ◽  
Real Life ◽  
Total Daily Dose ◽  
Daily Dose ◽  
Basal Bolus

Abstract Basal insulin dose in type 1 diabetes has been established empirically, since 2011 all guidelines suggest insulin basal dose less than 50% of total insulin dose in the pediatric population. However, in real life, basal dose indication has not changed in all patients in the basal-bolus treatment scheme. Objective: To measure how the physician indicates in real-life basal insulin dose in pediatric patients with type 1 diabetes in the basal-bolus scheme, and correlate this dose with metabolic control measured by glycated hemoglobin. Methods. This was a retrospective study, subjects include pediatric T1D (2 to 16 years, non-obese, using insulin more than 0.3 UI/Kg/d), more than 1 year of diagnostic, none of them in ketoacidosis, attended during 2019. The protocol was revised and accepted in the institution. Data were analyzed with Kruskal-Wallis, U Mann Withney, Pearson correlation test. Results: There were 141 subjects, male (51%), median age 13.3 years (3.6-15.9), median evolution time since diagnosis 8 years (1-14), pre-pubertal (Tanner stage 1, 22%), total daily dose 1.02 UI/Kg/d (0.3-2.19 UI/Kg/d). Basal insulin was glargine 50.4%, and NPH 49.6%, prandial insulin was lispro 66.7%, and regular human 29.8%. Children using 50% or less basal insulin of total insulin dose was 40.4%. The basal dose was 38% of total insulin dose in children less than 6 years, and 59% in children older than 6 years. (p=0.033). Glycated hemoglobin was less than 7.5% in 12.8%. The persons with glycated hemoglobin less than 7.5% used less basal insulin 0.38 u/kg/d, than those with higher glycated hemoglobin 0.57 U/kg/d (p=0.02) with no impact in total insulin dose (0.86 vs 1.05 UI/Kg/d, p=0.129). The correlation of the percentage of insulin basal dose and glycated hemoglobin was 0.279, p=0.001, meaning, more basal insulin, worse diabetes control. Conclusion: Lower basal insulin dose percentage from total daily dose is associated with better metabolic control in children treated with the basal-bolus scheme. There is high clinical inertia in the indication of basal insulin in older children.

scholarly journals Multicenter, open-label, two-arm pilot trial for safety reduction of basal insulin dose combined with SGLT2 inhibitor in type 1 diabetes mellitus: A study protocol for RISING-STAR

2020 ◽  
Author(s):  
Masahide Hamaguchi ◽  
Yoshitaka Hashimoto ◽  
Toru Tanaka ◽  
Goji Hasegawa ◽  
Michiyo Ishii ◽  
...  
Keyword(s):  
Diabetes Mellitus ◽  
Type 1 Diabetes ◽  
Type 1 Diabetes Mellitus ◽  
Sample Size ◽  
Basal Insulin ◽  
Insulin Dose ◽  
Sglt2 Inhibitor ◽  
Open Label ◽  
Group B

Abstract Background SGLT2 inhibitor combined with insulin is a novel therapy for patients with type 1 diabetes mellitus. Without the reduction of basal insulin, hypoglycemia could occur frequently in this therapy. However, ketoacidosis is an undesirable adverse effect in cases with basal insulin reduction. Methods This was a multicenter, open-label, two-arm study. Sixty subjects with type 1 diabetes mellitus were recruited from 7 hospitals. Subjects whose basal insulin daily dose to total daily insulin dose (TDD) ratio was < 0.4 were instructed not to reduce the basal insulin dose but to reduce the bolus insulin dose by 10% (Group A), and subjects with a basal-to-TDD ratio > 0.4 were instructed to reduce the basal insulin dose by 10% (Group B). We hypothesized that the frequency of hypoglycemia would be reduced in Group B. The primary outcome was the frequency of hypoglycemia per day during the intervention period (administration of SGLT2 inhibitor) as determined by self-monitoring of blood glucose (SMBG). The baseline number of hypoglycemic attacks was set at 7 ± 6 times/month. The minimum sample size required to achieve a significance of 0.05 for a one-sided t-test with a statistical power of 80% was determined. When the sample size was 26 patients in one group, the percent increase in hypoglycemia was more than 60%; thus, the sample size was estimated to be sufficient. The secondary outcome was the frequency of ketosis before and after the intervention. We aimed to confirm that the frequency of ketosis does not increase in Group B compared with Group A. The frequency of adverse events, including the frequency of hypoglycemia detected using flash glucose monitoring (FGM), was set as the safety endpoint. Discussion The RISING-STAR study will contribute results from a two-arm randomized trial in which a reduction in basal insulin dose is indicated or no reduction in basal insulin dose is instructed for concomitant use of SGLT2 inhibitors in patients with type 1 diabetes to prevent the development of hypoglycemia.Trial registration Registered with the Japan Registry of Clinical Trials (jRCTs051190114) on March 2, 2020.

scholarly journals Pre-Exercise Blood Glucose Levels Determine the Amount of Orally Administered Carbohydrates during Physical Exercise in Individuals with Type 1 Diabetes—A Randomized Cross-Over Trial

Nutrients ◽  
2019 ◽  
Vol 11 (6) ◽  
pp. 1287 ◽  
Author(s):  
Othmar Moser ◽  
Max L. Eckstein ◽  
Alexander Mueller ◽  
Philipp Birnbaumer ◽  
Felix Aberer ◽  
...  
Keyword(s):  
Type 1 Diabetes ◽  
Blood Glucose ◽  
Glucose Concentration ◽  
Basal Insulin ◽  
Blood Glucose Concentration ◽  
Insulin Dose ◽  
Moderate Intensity ◽  
Rank Test ◽  
The Impact

The aim of the study was to assess the amount of orally administered carbohydrates needed to maintain euglycemia during moderate-intensity exercise in individuals with type 1 diabetes. Nine participants with type 1 diabetes (four women, age 32.1 ± 9.0 years, BMI 25.5 ± 3.9 kg/m2, HbA1c 55 ± 7 mmol/mol (7.2 ± 0.6%)) on insulin Degludec were randomized to cycle for 55 min at moderate intensity (63 ± 7% VO2peak) for five consecutive days on either 75% or 100% of their regular basal insulin dose. The impact of pre-exercise blood glucose concentration on the carbohydrate requirement was analyzed by one-way ANOVA stratified for pre-exercise blood glucose quartiles. The effect of the basal insulin dose on the amount of orally administered carbohydrates was evaluated by Wilcoxon matched-pairs signed-rank test. The amount of orally administered carbohydrates during the continuous exercise sessions was similar for both trial arms (75% or 100% basal insulin) with median [IQR] of 36 g (9–62 g) and 36 g (9–66 g) (p = 0.78). The amount of orally administered carbohydrates was determined by pre-exercise blood glucose concentration for both trial arms (p = 0.03). Our study elucidated the importance of pre-exercise glucose concentration related orally administered carbohydrates to maintain euglycemia during exercise in individuals with type 1 diabetes.

Lower Basal Insulin Dose is Associated with Better Control in Type 1 Diabetes

2017 ◽  
Vol 182 ◽  
pp. 133-136 ◽  
Author(s):  
David Strich ◽  
Lucy Balagour ◽  
Joelle Shenker ◽  
David Gillis
Keyword(s):  
Type 1 Diabetes ◽  
Basal Insulin ◽  
Insulin Dose

scholarly journals Multicenter, Open-Label, Two-Arm, Pilot Trial for Safety Reduction of Basal Insulin Dose Combined with SGLT2 Inhibitor in Type 1 Diabetes Mellitus: Study Protocol for RISING-STAR.

2020 ◽  
Author(s):  
Masahide Hamaguchi ◽  
Yoshitaka Hashimoto ◽  
Toru Tanaka ◽  
Goji Hasegawa ◽  
Michiyo Ishii ◽  
...  
Keyword(s):  
Diabetes Mellitus ◽  
Type 1 Diabetes ◽  
Type 1 Diabetes Mellitus ◽  
Basal Insulin ◽  
Insulin Dose ◽  
Sglt2 Inhibitor ◽  
Daily Insulin ◽  
Daily Insulin Dose ◽  
Daily Dose

Abstract Background: SGLT2 inhibitor combined with insulin therapy is a novel therapy for patients with type 1 diabetes mellitus. Without the reduction of basal insulin, hypoglycemia could occur frequently in this therapy. But diabetic ketoacidosis is an undesirable adverse effect in case with basal insulin reduction. The aim of this study is to explore whether the reduction of the basal insulin dose combined with SGLT2 inhibitor in patients with type 1 diabetes mellitus can reduce the frequency of hypoglycemia and be used safely. We hypothesized that with an adequate basal insulin dose, the frequency of hypoglycemia is higher if the basal insulin dose is not reduced when combined with SGLT2 inhibitor.Methods and Analysis: The study has a two-arm design; 60 subjects with type 1 diabetes mellitus are being recruited from 7 hospitals. The basal insulin dose before the start of the SGLT2 inhibitor combination therapy is the reference. Study subjects are stratified into two groups based on the ratio of basal insulin daily dose (Basal) to total daily insulin dose (TDD). The subjects are instructed to reduce the basal insulin dose by 10% or 0% for Basal to TDD ratio of <0.4 and > 0.4, respectively.The primary outcome is the frequency of hypoglycemia per day during the intervention period (administration of SGLT2 inhibitor) as determined by self-monitoring of blood glucose (SMBG). The secondary outcome is the frequency of ketosis before and after the intervention. Discussion: 10% basal insulin reduction could reduce hypoglycemia as well as could not increase ketosis in case that the ratio of basal insulin daily dose to total daily insulin dose is 0.4 or higher, which improve the efficacy and safety of SGLT2 inhibitor treatment patients with type 1 diabetes mellitus.Ethics and Dissemination: The study was approved by Kyoto Prefectural University of Medicine, Clinical Research Review Board (CRB5180001). The results will be disseminated through presentations at appropriate conferences and meetings, and published in peer-reviewed journals.Trial registration: Registered with Japan Registry of Clinical Trials (jRCTs051190114) on 2 March, 2020. https://rctportal.niph.go.jp/detail/jr?trial_id=jRCTs051190114)

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