A pilot non-inferiority randomized controlled trial to assess automatic adjustments of insulin doses in adolescents with type 1 diabetes on multiple daily injections therapy.
Adolescent
Algorithms
Automation
Blood Glucose
/ analysis
Blood Glucose Self-Monitoring
/ instrumentation
Child
Diabetes Mellitus, Type 1
/ blood
Drug Administration Schedule
Drug Dosage Calculations
Equivalence Trials as Topic
Feasibility Studies
Female
Humans
Injections, Subcutaneous
Insulin
/ administration & dosage
Insulin Infusion Systems
Male
Pilot Projects
Quebec
Treatment Outcome
decision support system
learning algorithm
multiple daily injections
treatment adjustments
Journal
Pediatric diabetes
ISSN: 1399-5448
Titre abrégé: Pediatr Diabetes
Pays: Denmark
ID NLM: 100939345
Informations de publication
Date de publication:
09 2020
09 2020
Historique:
received:
21
01
2020
revised:
15
04
2020
accepted:
11
05
2020
pubmed:
18
5
2020
medline:
3
8
2021
entrez:
18
5
2020
Statut:
ppublish
Résumé
Multiple daily injections (MDI) therapy for type 1 diabetes involves basal and bolus insulin doses. Non-optimal insulin doses contribute to the lack of satisfactory glycemic control. We aimed to evaluate the feasibility of an algorithm that optimizes daily basal and bolus doses using glucose monitoring systems for MDI therapy users. We performed a pilot, non-inferiority, randomized, parallel study at a diabetes camp comparing basal-bolus insulin dose adjustments made by camp physicians (PA) and a learning algorithm (LA), in children and adolescents on MDI therapy. Participants wore a glucose sensor and underwent 11 days of daily dose adjustments in either arm. Algorithm adjustments were reviewed and approved by a physician. The last 7 days were examined for outcomes. Twenty-one youths (age 13.3 [SD, 3.7] years; 13 females; HbA1c 8.6% [SD, 1.8]) were randomized to either group (LA [n = 10] or PA [n = 11]). The algorithm made 293 adjustments with a 92% acceptance rate from the camp physicians. In the last 7 days, the time in target glucose (3.9-10 mmol/L) in LA (39.5%, SD, 20.7) was similar to PA (38.4%, SD, 15.6) (P = .89). The number of hypoglycemic events per day in LA (0.3, IQR, [0.1-0.6]) was similar to PA (0.2, IQR, [0.0-0.4]) (P = .42). There was no incidence of severe hypoglycemia nor ketoacidosis. In this pilot study, glycemic outcomes in the LA group were similar to the PA group. This algorithm has the potential to facilitate MDI therapy, and longer and larger studies are warranted.
Sections du résumé
BACKGROUND
Multiple daily injections (MDI) therapy for type 1 diabetes involves basal and bolus insulin doses. Non-optimal insulin doses contribute to the lack of satisfactory glycemic control. We aimed to evaluate the feasibility of an algorithm that optimizes daily basal and bolus doses using glucose monitoring systems for MDI therapy users.
METHODS
We performed a pilot, non-inferiority, randomized, parallel study at a diabetes camp comparing basal-bolus insulin dose adjustments made by camp physicians (PA) and a learning algorithm (LA), in children and adolescents on MDI therapy. Participants wore a glucose sensor and underwent 11 days of daily dose adjustments in either arm. Algorithm adjustments were reviewed and approved by a physician. The last 7 days were examined for outcomes.
RESULTS
Twenty-one youths (age 13.3 [SD, 3.7] years; 13 females; HbA1c 8.6% [SD, 1.8]) were randomized to either group (LA [n = 10] or PA [n = 11]). The algorithm made 293 adjustments with a 92% acceptance rate from the camp physicians. In the last 7 days, the time in target glucose (3.9-10 mmol/L) in LA (39.5%, SD, 20.7) was similar to PA (38.4%, SD, 15.6) (P = .89). The number of hypoglycemic events per day in LA (0.3, IQR, [0.1-0.6]) was similar to PA (0.2, IQR, [0.0-0.4]) (P = .42). There was no incidence of severe hypoglycemia nor ketoacidosis.
CONCLUSIONS
In this pilot study, glycemic outcomes in the LA group were similar to the PA group. This algorithm has the potential to facilitate MDI therapy, and longer and larger studies are warranted.
Substances chimiques
Blood Glucose
0
Insulin
0
Types de publication
Journal Article
Randomized Controlled Trial
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
950-959Subventions
Organisme : CIHR
Pays : Canada
Informations de copyright
© 2020 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.
Références
Todd JA. Etiology of type 1 diabetes. Immunity. 2010;32(4):457-467.
Diabetes Control and Complications Trial Research Group. The relationship of glycemic exposure (HbA1c) to the risk of development and progression of retinopathy in the diabetes control and complications trial. Diabetes. 1995;44(8):968-983.
Nathan DM, Cleary PA, Backlund J-YC, et al. Intensive diabetes treatment and cardiovascular disease in patients with type 1 diabetes. N Engl J Med. 2005;353(25):2643-2653.
Foster NC, Beck RW, Miller KM, et al. State of type 1 diabetes management and outcomes from the T1D exchange in 2016-2018. Diabetes Technol Ther. 2019;21(2):66-72.
Waldhausl WK. The physiological basis of insulin treatment: clinical aspects. Diabetologia. 1986;29(12):837-849.
Nimri R, Dassau E, Segall T, et al. Adjusting insulin doses in patients with type 1 diabetes that use insulin pump and continuous glucose monitoring: variations among countries and physicians. Diabetes Obes Metab. 2018;20(10):2458-2466.
Dassau E, Pinsker JE, Kudva YC, et al. Twelve-week 24/7 ambulatory artificial pancreas with weekly adaptation of insulin delivery settings: effect on hemoglobin A1c and hypoglycemia. Diabetes Care. 2017;40(12):1719-1726.
Palisaitis E, Fathi AE, von Oettingen JE, et al. The efficacy of basal rate and carbohydrate ratio learning algorithm for closed-loop insulin delivery (artificial pancreas) in youth with type 1 diabetes in a diabetes camp. Diabetes Technol Ther. 2020;22(3):185-194.
Palerm CC et al. Prandial insulin dosing using run-to-run control: application of clinical data and medical expertise to define a suitable performance metric. Diabetes Care. 2007;30(5):1131-1136.
Breton MD, Patek SD, Lv D, et al. Continuous glucose monitoring and insulin informed advisory system with automated titration and dosing of insulin reduces glucose variability in type 1 diabetes mellitus. Diabetes Technol Ther. 2018;20(8):531-540.
Reddy M, Pesl P, Xenou M, et al. Clinical safety and feasibility of the advanced bolus calculator for type 1 diabetes based on case-based reasoning: a 6-week nonrandomized single-arm pilot study. Diabetes Technol Ther. 2016;18(8):487-493.
Owens C, Zisser H, Jovanovic L, et al. Run-to-run control of blood glucose concentrations for people with Type 1 diabetes mellitus. IEEE Trans Biomed Eng. 2006;53(6):996-1005.
Rewers MJ, Pillay K, International Society for Pediatric and Adolescent Diabetes, et al. ISPAD Clinical Practice Consensus Guidelines 2014. Assessment and monitoring of glycemic control in children and adolescents with diabetes. Pediatr Diabetes. 2014;20(S20):102-114.
Juvenile Diabetes Research Foundation Continuous Glucose Monitoring Study Group, Tamborlane WV, Beck RW, et al. Continuous glucose monitoring and intensive treatment of type 1 diabetes. N Engl J Med. 2008;359(14):1464-1476.
Pickup JC, Ford Holloway M, Samsi K. Real-time continuous glucose monitoring in type 1 diabetes: a qualitative framework analysis of patient narratives. Diabetes Care. 2015;38(4):544-550.
Heinemann L. Variability of insulin absorption and insulin action. Diabetes Technol Ther. 2002;4(5):673-682.
Association, A.D. Physical activity/exercise and diabetes mellitus. Diabetes Care. 2003;26(suppl 1):s73-s77.
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;38(6):1008-1015.
Tsoukas M, Rutkowski J, El-Fathi A, et al. Accuracy of FreeStyle Libre in adults with type 1 diabetes: the effect of sensor age. Diabetes Technol Ther. 2020;22(3):203-207.
Oskarsson P, Antuna R, Geelhoed-Duijvestijn P, Kröger J, Weitgasser R, Bolinder J. Impact of flash glucose monitoring on hypoglycaemia in adults with type 1 diabetes managed with multiple daily injection therapy: a pre-specified subgroup analysis of the IMPACT randomised controlled trial. Diabetologia. 2018;61(3):539-550.