Clinical trial NCT05152121: Additional Insulin for High Fat/Protein in Type 1 Diabetes
Official title: The Effect of Fat - Protein Counting on Glycemic Variability in Children and Adolescents With Type 1 Diabetes Mellitus
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 1 Diabetes
Adolescent
Keywords: type 1 diabetes
dietary fat
high energy density meal
glycemic variability
Lead sponsor: Ege University
Sponsor class: OTHER
First posted: 2021-12-09
Enrollment: 20
Sex: ALL
Minimum age (years): 9
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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).

Detailed description: Children and adolescents with T1DM between the ages of 9-18 and undergoing insulin infusion pump therapy followed in Ege University Pediatric Endocrinology Department will be randomly selected regardless of metabolic control. The selection of the cases will be made from the beginning of the study as the first 30 patients who meet the research participation criteria and agree to participate in the study. Before the research starts, the cases will be told about the application of CGMS, their responsibilities in the research, and an appointment will be given for the insertion of CGMS and this procedure will be applied to all participants. On the day of the appointment, the participant will be put on CGMS, and as long as CGMS is attached, they will be asked to measure capillary blood glucose in their diaries and record them. The subjects will be checked whether they are within the target blood glucose values for 2 days before consuming the test meal and normoglycemia will be provided. On the first day of the study, a test meal with 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 carbohydrate counting-normal bolus insulin will be given by administration. On the second day of the study, the additional insulin for fat and protein will be given as a dual wave bolus instead of the normal bolus for the test meal. Then, CGMS will be extracted from the cases, transferred to the computer, and analysis will be made by the researcher, taking into account the capillary blood glucose measurements in the diary.

Eligibility criteria: Inclusion Criteria:

1. 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.
2. Those with a body mass index between -2- + 2 SD

Exclusion Criteria:

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

Primary outcomes:
measure: AUC
timeFrame: AUC was evaluated the day where only carbs were counted and the day were fat and proteins were counted
Secondary outcomes:
measure: hypoglycemia epizode
timeFrame: Hypoglycemia was evaluated the day where only carbs were counted and the day were fat and proteins were counted
Other outcomes:
Locations:
city: İzmir
country: Turkey
facility: Ege University Faculty of Medicine Department of Pediatrics
Study officials:
affiliation: Ege University
name: Sukran Darcan, MD Prof
role: STUDY_CHAIR
affiliation: Ege University Fac Of Medicine Department of Pediatrics
name: Yasemin Atik Altınok, pHD
role: PRINCIPAL_INVESTIGATOR
affiliation: Ege University Fac Of Medicine Department of Pediatrics
name: Hafize Cetin Işıklar, Nurse
role: PRINCIPAL_INVESTIGATOR
affiliation: Ege University Fac Of Medicine Department of Pediatrics
name: Gunay Demir, MSci Nurse
role: PRINCIPAL_INVESTIGATOR
affiliation: Ege University Fac Of Medicine Department of Pediatrics
name: Samim Ozen, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.