scholarly journals A Single Load of Fructose Attenuates the Risk of Exercise-Induced Hypoglycemia in Adults With Type 1 Diabetes on Ultra-Long-Acting Basal Insulin: A Randomized, Open-Label, Crossover Proof-of-Principle Study

Diabetes Care ◽  
2020 ◽  
Vol 43 (9) ◽  
pp. 2010-2016
Author(s):  
Christophe Kosinski ◽  
David Herzig ◽  
Céline Isabelle Laesser ◽  
Christos T. Nakas ◽  
Andreas Melmer ◽  
...  
Keyword(s):  
Type 1 Diabetes ◽  
Basal Insulin ◽  
Open Label ◽  
Exercise Induced ◽  
Long Acting ◽  
Proof Of Principle

scholarly journals A single load of fructose attenuates the risk of exercise-induced hypoglycaemia in adults with type 1 diabetes on ultra-long-acting basal insulin - a randomised, open-label, crossover proof-of-principle study

2020 ◽  
Author(s):  
Christophe Kosinski ◽  
David Herzig ◽  
Céline Isabelle Laesser ◽  
Christos Nakas ◽  
Andreas Melmer ◽  
...  
Keyword(s):  
Type 1 Diabetes ◽  
Plasma Glucose ◽  
Basal Insulin ◽  
Primary Outcome ◽  
Open Label ◽  
Fructose Intake ◽  
Lactate Levels ◽  
Exercise Induced ◽  
Long Acting

<b>Objective</b> <p>While the adjustment of insulin is an established strategy to reduce the risk of exercise-associated hypoglycaemia for individuals with type 1 diabetes, it is not easily feasible for those treated with ultra-long acting basal insulin. The present study determined whether pre-exercise intake of fructose attenuates the risk of exercise-induced hypoglycaemia in individuals with type 1 diabetes using insulin degludec.</p> <p><b>Research design and method</b></p> <p>Fourteen male adults with type 1 diabetes completed two 60min aerobic cycling sessions with or without prior intake (30min) of 20g of fructose, in a randomised two-period crossover design. Exercise was performed in the morning in a fasted state without prior insulin reduction, and after 48h of standardised diet. The primary outcome was time to hypoglycaemia (plasma glucose ≤3.9mmol/L) during exercise.</p> <p><b>Results</b></p> <p>Intake of fructose resulted in one hypoglycaemic event at 60min compared to six hypoglycaemic events at 27.5±9.4min of exercise in the control condition, translating into a risk reduction of 87.8% (hazard ratio 0.12 [95% CI 0.02; 0.66]; p=0.015). Mean plasma glucose during exercise was 7.3±1.4mmol/L with fructose and 5.5±1.1mmol/L during control (p<0.001). Lactate levels were higher at rest in the 30min following fructose intake (p<0.001) but were not significantly different from control during exercise (p=0.32). Substrate oxidation during exercise did not significantly differ between the conditions (p=0.73 for carbohydrate and p=0.48 for fat oxidation). Fructose was well tolerated.</p> <p><b>Conclusions</b></p> <p>Pre-exercise intake of fructose is an easily feasible, effective and well-tolerated strategy to alleviate the risk of exercise-induced hypoglycaemia whilst avoiding hyperglycaemia in individuals with type 1 diabetes on ultra-long acting insulin. </p>

scholarly journals A single load of fructose attenuates the risk of exercise-induced hypoglycaemia in adults with type 1 diabetes on ultra-long-acting basal insulin - a randomised, open-label, crossover proof-of-principle study

2020 ◽  
Author(s):  
Christophe Kosinski ◽  
David Herzig ◽  
Céline Isabelle Laesser ◽  
Christos Nakas ◽  
Andreas Melmer ◽  
...  
Keyword(s):  
Type 1 Diabetes ◽  
Plasma Glucose ◽  
Basal Insulin ◽  
Primary Outcome ◽  
Open Label ◽  
Fructose Intake ◽  
Lactate Levels ◽  
Exercise Induced ◽  
Long Acting

<b>Objective</b> <p>While the adjustment of insulin is an established strategy to reduce the risk of exercise-associated hypoglycaemia for individuals with type 1 diabetes, it is not easily feasible for those treated with ultra-long acting basal insulin. The present study determined whether pre-exercise intake of fructose attenuates the risk of exercise-induced hypoglycaemia in individuals with type 1 diabetes using insulin degludec.</p> <p><b>Research design and method</b></p> <p>Fourteen male adults with type 1 diabetes completed two 60min aerobic cycling sessions with or without prior intake (30min) of 20g of fructose, in a randomised two-period crossover design. Exercise was performed in the morning in a fasted state without prior insulin reduction, and after 48h of standardised diet. The primary outcome was time to hypoglycaemia (plasma glucose ≤3.9mmol/L) during exercise.</p> <p><b>Results</b></p> <p>Intake of fructose resulted in one hypoglycaemic event at 60min compared to six hypoglycaemic events at 27.5±9.4min of exercise in the control condition, translating into a risk reduction of 87.8% (hazard ratio 0.12 [95% CI 0.02; 0.66]; p=0.015). Mean plasma glucose during exercise was 7.3±1.4mmol/L with fructose and 5.5±1.1mmol/L during control (p<0.001). Lactate levels were higher at rest in the 30min following fructose intake (p<0.001) but were not significantly different from control during exercise (p=0.32). Substrate oxidation during exercise did not significantly differ between the conditions (p=0.73 for carbohydrate and p=0.48 for fat oxidation). Fructose was well tolerated.</p> <p><b>Conclusions</b></p> <p>Pre-exercise intake of fructose is an easily feasible, effective and well-tolerated strategy to alleviate the risk of exercise-induced hypoglycaemia whilst avoiding hyperglycaemia in individuals with type 1 diabetes on ultra-long acting insulin. </p>

Long-acting Insulin Analogs Effect on gh/igf Axis of Children with Type 1 Diabetes: a Randomized, Open-label, Two-period, Cross-over Trial

2016 ◽  
Vol 124 (05) ◽  
pp. 276-282 ◽  
Author(s):  
V. Cherubini ◽  
B. Pintaudi ◽  
A. Iannilli ◽  
M. Pambianchi ◽  
L. Ferrito ◽  
...  
Keyword(s):  
Type 1 Diabetes ◽  
Insulin Analogs ◽  
Open Label ◽  
Acting Insulin ◽  
Long Acting

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 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.

The Comparative Dosing and Glycemic Control of Intermediate and Long-Acting Insulins in Adult Patients With Type 1 and 2 Diabetes Mellitus

2021 ◽  
pp. 875512252110557
Author(s):  
Anna Kabakov ◽  
Andrew Merker
Keyword(s):  
Diabetes Mellitus ◽  
Type 2 Diabetes ◽  
Type 1 Diabetes ◽  
Type 2 Diabetes Mellitus ◽  
Glycemic Control ◽  
Type 1 Diabetes Mellitus ◽  
Basal Insulin ◽  
Long Acting

Objective: The various basal insulin products possess differences in pharmacokinetics that can significantly impact glycemic control and total daily basal insulin dosing. In addition, there will be instances where transitions between the different long-acting insulins will need to be made. Because every basal insulin product is not interchangeable on a 1:1 unit-to-unit basis, it is important for health care providers to understand the expected dose adjustments necessary to maintain a similar level of glycemic control. Data Sources: A Medline and Web of Science search was conducted in September 2021 using the following keywords and medical subjecting headings: NPH, glargine, detemir, type 1 diabetes mellitus, and type 2 diabetes mellitus. Study Selection and Data Extraction: Included articles were those that followed adult patients with type 1 diabetes mellitus and/or type 2 diabetes mellitus and compared the following types of insulin: “NPH and glargine,” “NPH and detemir,” and “glargine and detemir” for at least 4 weeks, had documented basal insulin (BI) doses, and excluded pregnant patients. Data synthesis: Twenty-five articles were found that include adult type 1 and/or type 2 diabetes mellitus patients. Once daily NPH can be converted unit-to-unit to glargine or detemir. Twice daily NPH converted to glargine or detemir requires an initial 20% reduction in BI dose. An increase in dose of BI is recommended when transitioning from glargine to detemir. Glargine and detemir consistently resulted in improved glycemic control with lower incidence of hypoglycemic events compared with NPH. Conclusions: When transitioning between long-acting insulins, the doses are not always interchangeable on a 1:1 basis. Unit dose adjustments are likely if transitioning between BIs and can influence short-term parameters in the acute care setting and long-term parameters in the outpatient setting.

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