Additional Insulin for High Fat/Protein in Type 1 Diabetes

NCT05152121 | Completed

• 1 other identifier: 16-12.1/44
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

Aim: Dietary carbohydrate is the predominant macronutrient affecting postprandial blood glucose excursions, dietary fat and protein can also significantly impact the postprandial glycemic profile. The aim of this study is to compare the impact of additional dose of extended insulin bolus; using Pankowsko algorithm (PA) to usual standard carbohydrate counting (CC) on postprandial glucose excursions for high fat /high energy density mixed meal for 12 hours. Methods: In this single-center, non-blinded, randomized, crossover study a high fat, high energy density test meal containing 80 gram carbohydrate (34%), 70 gram fat (66%) and 35 g protein (14%) was given using standard carbohydrate counting (CC) on the first test day and PA was used for the second test day for the same meal. Two methods were compared on postprandial early (0-120 min), late (120-720 min) and total (0-720 min) glucose response in 20 patients with type 1 diabetes mellitus (T1DM), aged 9-18 years on continuous subcutan insulin infusion (CSII) therapy using continuous glucose monitoring system (CGMS).

Conditions

Type 1 Diabetes; Adolescent

Keywords

type 1 diabetes; dietary fat; high energy density meal; glycemic variability

Outcome Measures

Primary Outcomes (1)

• AUC

  The primary outcomes were glucose area under the curve (AUC) and % of time spent in normoglycemia according to CC; PA and modified PA algorithms.

  AUC was evaluated the day where only carbs were counted and the day were fat and proteins were counted

Secondary Outcomes (1)

• hypoglycemia epizode

  Hypoglycemia was evaluated the day where only carbs were counted and the day were fat and proteins were counted

Study Arms (1)

carb counting

OTHER

Patients using insulin infusion pumps will be placed CGMS for 2 days before starting the study to check whether they are within the target blood glucose levels and normoglycemia will be provided. The content of the first day of the study; The test meal, which is 80 g carbohydrate (29.3%), 70.2 g fat (57.9%), 34.7 g protein (12.7%), will be consumed in the evening meal and normal bolus insulin will be given according to carbohydrate counting. On the second day of the study, instead of the normal bolus for the test meal, the additional insulin for fat-protein by dual wave bolus that.The data obtained will be analyzed by evaluating the CGMS data of all patients by a pediatric endocrinologist experienced in diabetes, CGMS and insulin infusion pump therapy.

Other: Carb and fat counting

Interventions

Carb and fat counting OTHER

In the 7 days leading up to the study, participants were contacted to review blood glucose levels with CGMS, food and activity diary. basal rates and insulin carbohydrate ratio and sensitivity factor were changed according to the CGMS values and normoglycemia was achieved.In the study day same meals were served which included high fat, high energy density test meal containing 80 gram carbohydrate (34%), 70 gram fat (66%) and 35 g protein (14%).The participants had to have no glucose fluctuations 2 hours before study entry based on CGMS, no correction boluses for at least 4 hours before the test meal consumption and fasting glycemia in the range of 70-180 mg/dL on both study days.The participants received the test meal calculating insulin dose by CC on the first study day and calculating insulin dose by and fat/protein counting in the second study day. The test meal consumption was completed in 20 minutes under supervision by a caregiver and a dietician of the research team

carb counting

Eligibility Criteria

• Age: 9 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Children-adolescents with Type 1 DM between the ages of 9-18 and undergoing insulin infusion pump therapy followed by Ege University Faculty of Medicine, Department of Pediatric Endocrine.
• Those with a body mass index between -2- + 2 SD

You may not qualify if:

• Cases that do not accept to fill in the 'Informed Consent Form'
• Cases with diseases accompanying T1DM (autoimmune diseases such as celiac, cystic fibrosis, etc.)
• Body mass index \<-2 SD and\> +2 SD

Sponsors & Collaborators

• Ege University: lead

Study Sites (1)

Ege University Faculty of Medicine Department of Pediatrics

Izmir, 35100, Turkey (Türkiye)

Location

Related Publications (19)

• Diabetes Control and Complications Trial Research Group; Nathan DM, Genuth S, Lachin J, Cleary P, Crofford O, Davis M, Rand L, Siebert C. The effect of intensive treatment of diabetes on the development and progression of long-term complications in insulin-dependent diabetes mellitus. N Engl J Med. 1993 Sep 30;329(14):977-86. doi: 10.1056/NEJM199309303291401.

  PMID: 8366922 BACKGROUND

• Gingras V, Bonato L, Messier V, Roy-Fleming A, Smaoui MR, Ladouceur M, Rabasa-Lhoret R. Impact of macronutrient content of meals on postprandial glucose control in the context of closed-loop insulin delivery: A randomized cross-over study. Diabetes Obes Metab. 2018 Nov;20(11):2695-2699. doi: 10.1111/dom.13445. Epub 2018 Jul 18.

  PMID: 29931719 BACKGROUND

• American Diabetes Association. 5. Facilitating Behavior Change and Well-being to Improve Health Outcomes: Standards of Medical Care in Diabetes-2021. Diabetes Care. 2021 Jan;44(Suppl 1):S53-S72. doi: 10.2337/dc21-S005.

  PMID: 33298416 BACKGROUND

• Smart CE, Annan F, Higgins LA, Jelleryd E, Lopez M, Acerini CL. ISPAD Clinical Practice Consensus Guidelines 2018: Nutritional management in children and adolescents with diabetes. Pediatr Diabetes. 2018 Oct;19 Suppl 27:136-154. doi: 10.1111/pedi.12738. No abstract available.

  PMID: 30062718 BACKGROUND

• Pankowska E, Szypowska A, Lipka M, Szpotanska M, Blazik M, Groele L. Application of novel dual wave meal bolus and its impact on glycated hemoglobin A1c level in children with type 1 diabetes. Pediatr Diabetes. 2009 Aug;10(5):298-303. doi: 10.1111/j.1399-5448.2008.00471.x. Epub 2008 Oct 20.

  PMID: 19175902 BACKGROUND

• Danne T, Nimri R, Battelino T, Bergenstal RM, Close KL, DeVries JH, Garg S, Heinemann L, Hirsch I, Amiel SA, Beck R, Bosi E, Buckingham B, Cobelli C, Dassau E, Doyle FJ 3rd, Heller S, Hovorka R, Jia W, Jones T, Kordonouri O, Kovatchev B, Kowalski A, Laffel L, Maahs D, Murphy HR, Norgaard K, Parkin CG, Renard E, Saboo B, Scharf M, Tamborlane WV, Weinzimer SA, Phillip M. International Consensus on Use of Continuous Glucose Monitoring. Diabetes Care. 2017 Dec;40(12):1631-1640. doi: 10.2337/dc17-1600.

  PMID: 29162583 BACKGROUND

• Bell KJ, Smart CE, Steil GM, Brand-Miller JC, King B, Wolpert HA. Impact of fat, protein, and glycemic index on postprandial glucose control in type 1 diabetes: implications for intensive diabetes management in the continuous glucose monitoring era. Diabetes Care. 2015 Jun;38(6):1008-15. doi: 10.2337/dc15-0100.

  PMID: 25998293 BACKGROUND

• Jones SM, Quarry JL, Caldwell-McMillan M, Mauger DT, Gabbay RA. Optimal insulin pump dosing and postprandial glycemia following a pizza meal using the continuous glucose monitoring system. Diabetes Technol Ther. 2005 Apr;7(2):233-40. doi: 10.1089/dia.2005.7.233.

  PMID: 15857224 RESULT

• Wolever TM, Mullan YM. Sugars and fat have different effects on postprandial glucose responses in normal and type 1 diabetic subjects. Nutr Metab Cardiovasc Dis. 2011 Sep;21(9):719-25. doi: 10.1016/j.numecd.2010.12.005. Epub 2011 Feb 16.

  PMID: 21330118 RESULT

• Pankowska E, Blazik M, Groele L. Does the fat-protein meal increase postprandial glucose level in type 1 diabetes patients on insulin pump: the conclusion of a randomized study. Diabetes Technol Ther. 2012 Jan;14(1):16-22. doi: 10.1089/dia.2011.0083. Epub 2011 Oct 20.

  PMID: 22013887 RESULT

• Smart CE, Evans M, O'Connell SM, McElduff P, Lopez PE, Jones TW, Davis EA, King BR. Both dietary protein and fat increase postprandial glucose excursions in children with type 1 diabetes, and the effect is additive. Diabetes Care. 2013 Dec;36(12):3897-902. doi: 10.2337/dc13-1195. Epub 2013 Oct 29.

  PMID: 24170749 RESULT

• Wolpert HA, Atakov-Castillo A, Smith SA, Steil GM. Dietary fat acutely increases glucose concentrations and insulin requirements in patients with type 1 diabetes: implications for carbohydrate-based bolus dose calculation and intensive diabetes management. Diabetes Care. 2013 Apr;36(4):810-6. doi: 10.2337/dc12-0092. Epub 2012 Nov 27.

  PMID: 23193216 RESULT

• Paterson MA, Smart CEM, Lopez PE, Howley P, McElduff P, Attia J, Morbey C, King BR. Increasing the protein quantity in a meal results in dose-dependent effects on postprandial glucose levels in individuals with Type 1 diabetes mellitus. Diabet Med. 2017 Jun;34(6):851-854. doi: 10.1111/dme.13347. Epub 2017 Mar 19.

  PMID: 28257160 RESULT

• van der Hoogt M, van Dyk JC, Dolman RC, Pieters M. Protein and fat meal content increase insulin requirement in children with type 1 diabetes - Role of duration of diabetes. J Clin Transl Endocrinol. 2017 Oct 10;10:15-21. doi: 10.1016/j.jcte.2017.10.002. eCollection 2017 Dec.

  PMID: 29204367 RESULT

• Neu A, Behret F, Braun R, Herrlich S, Liebrich F, Loesch-Binder M, Schneider A, Schweizer R. Higher glucose concentrations following protein- and fat-rich meals - the Tuebingen Grill Study: a pilot study in adolescents with type 1 diabetes. Pediatr Diabetes. 2015 Dec;16(8):587-91. doi: 10.1111/pedi.12224. Epub 2014 Oct 20.

  PMID: 25330823 RESULT

• Paterson MA, Smart CE, Lopez PE, McElduff P, Attia J, Morbey C, King BR. Influence of dietary protein on postprandial blood glucose levels in individuals with Type 1 diabetes mellitus using intensive insulin therapy. Diabet Med. 2016 May;33(5):592-8. doi: 10.1111/dme.13011. Epub 2015 Dec 6.

  PMID: 26499756 RESULT

• Evans M, Smart CEM, Paramalingam N, Smith GJ, Jones TW, King BR, Davis EA. Dietary protein affects both the dose and pattern of insulin delivery required to achieve postprandial euglycaemia in Type 1 diabetes: a randomized trial. Diabet Med. 2019 Apr;36(4):499-504. doi: 10.1111/dme.13875. Epub 2019 Feb 20.

  PMID: 30537305 RESULT

• Lopez PE, Evans M, King BR, Jones TW, Bell K, McElduff P, Davis EA, Smart CE. A randomized comparison of three prandial insulin dosing algorithms for children and adolescents with Type 1 diabetes. Diabet Med. 2018 Oct;35(10):1440-1447. doi: 10.1111/dme.13703. Epub 2018 Jun 19.

  PMID: 29873107 RESULT

• Kordonouri O, Hartmann R, Remus K, Blasig S, Sadeghian E, Danne T. Benefit of supplementary fat plus protein counting as compared with conventional carbohydrate counting for insulin bolus calculation in children with pump therapy. Pediatr Diabetes. 2012 Nov;13(7):540-4. doi: 10.1111/j.1399-5448.2012.00880.x. Epub 2012 Jul 6.

  PMID: 22765260 RESULT

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Interventions

Qa-SNARE Proteins

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Q-SNARE Proteins; SNARE Proteins; Membrane Fusion Proteins; Membrane Proteins; Proteins; Amino Acids, Peptides, and Proteins; Vesicular Transport Proteins

Study Officials

• Sukran Darcan, MD Prof

  Ege University

  STUDY CHAIR

• Yasemin Atik Altınok, pHD

  Ege University Fac Of Medicine Department of Pediatrics

  PRINCIPAL INVESTIGATOR

• Hafize Cetin Işıklar, Nurse

  Ege University Fac Of Medicine Department of Pediatrics

  PRINCIPAL INVESTIGATOR

• Gunay Demir, MSci Nurse

  Ege University Fac Of Medicine Department of Pediatrics

  PRINCIPAL INVESTIGATOR

• Samim Ozen, MD,PhD

  Ege University Fac Of Medicine Department of Pediatrics

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dietician PhD

Study Record Dates

• First Submitted: November 29, 2021
• First Posted: December 9, 2021
• Study Start: July 1, 2017
• Primary Completion: April 30, 2018
• Study Completion: December 31, 2019
• Last Updated: December 30, 2021

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)