Exercise-induced Glycemic Variations and Hybrid Closed-loop Systems

NCT05736263 | Unknown

• 1 other identifier: 2022-01
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

Type 1 diabetes is characterized by high risk of hypoglycemia and associated fear of hypoglycemia. Hypoglycemia risk is higher during and after physical activity, especially aerobic activity of long duration. Fear of hypoglycemia can result in avoidance of exercise or overcompensatory eating, both related to worse metabolic control and increased cardiometabolic risk. Hybrid closed-loop (HCL)systems have significantly improved risk of hypoglycemia. They also offer the possibility to set a temporary target for physical activity, further reducing the risk of hypoglycemia during physical activity. Although temporary target seems to work rather well with moderate-intensity aerobic exercise, little data is available for other types of exercise, like resistance exercise, high-intensity interval exercise, combined modalities of exercise, in which the temporary target seems to perform less well. The present study aims to test the performance of current HCL systems under different exercise conditions and evaluate the relationship between different exercise variables (recorded during exercise), physical activity variables (measured by accelerometry) and glycemic variations in HCL system users.

Conditions

Type 1 Diabetes; Exercise

Keywords

Exercise-induced glycemic variations; hybrid closed-loop systems; Type 1 Diabetes

Outcome Measures

Primary Outcomes (2)

• CGM-derived percentage time in range (TIR) during and after exercise trials

  percentage of time spent in the glycemic control area 70-180 mg/dl continuously measured by CGM on exercise days

  3 hours

• Comparison of CGM-derived percentage time in range (TIR) when temporary target is enabled or disabled during exercise

  Effect of enabling/disabling the temporary exercise target on time in range during and after exercise trials.

  3 hours

Secondary Outcomes (7)

• CGM-derived percentage time in glycemic range range (TIR 70-180 mg/dl), during and after exercise trials

  Immediate (3 hours) and delayed (24 hours) glucose response to exercise

• CGM-derived percentage time in tight glycemic range range 80-140 mg/dl, during and after exercise trials

  Glucose response 24 hours after exercise

• CGM-derived percentage time above range (TAR > 180 mg/dl) during and after exercise trials

  Immediate (3 hours) and delayed (24 hours) glucose response to exercise

• CGM-derived percentage time above range (TAR >250 mg/dl) during and after exercise trials

  Immediate (3 hours) and delayed (24 hours) glucose response to exercise

• Calculation of Hypo/hyperglycemia risk from CGM data

  Immediate (3 hours) and delayed (24 hours) glucose response to exercise

Other Outcomes (3)

• Associations between physical activity and glycemic variations

  7 days

• Associations between sleep quantity and glycemic variations

  7 days

• Associations between sleep quality and glycemic variations

  7 days

Study Arms (4)

Moderate intensity exercise

EXPERIMENTAL

Individuals with type 1 diabetes on intensive insulin treatment with hybrid closed-loop systems will perform moderate-intensity aerobic exercise

Behavioral: Moderate intensity exercise

High intensity interval exercise

EXPERIMENTAL

Individuals with type 1 diabetes on intensive insulin treatment with hybrid closed-loop systems will perform High intensity interval exercise

Behavioral: High intensity interval exercise

Combined exercise

EXPERIMENTAL

Individuals with type 1 diabetes on intensive insulin treatment with hybrid closed-loop systems will perform combined exercise

Behavioral: Combined exercise

Resistance exercise

EXPERIMENTAL

Individuals with type 1 diabetes on intensive insulin treatment with hybrid closed-loop systems will perform resistance exercise

Behavioral: Resistance exercise

Interventions

Moderate intensity exercise BEHAVIORAL

moderate intensity aerobic exercise trial

Moderate intensity exercise

High intensity interval exercise BEHAVIORAL

High intensity interval exercise trial

High intensity interval exercise

Combined exercise BEHAVIORAL

Combined aerobic and resistance exercise trial

Combined exercise

Resistance exercise BEHAVIORAL

Resistance exercise trial

Resistance exercise

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 years and ≤ 65 years old
• T1DM duration ≥ 1 year;
• Automated insulin pump therapy (Hybrid closed-loop) ≥ 12 weeks; HbA1c \< 10 %
• Physically able to complete the study protocol

You may not qualify if:

• severe diabetic nephropathy, retinopathy and neuropathy;
• acute cardiovascular events in the last 6 months;
• presence of diabetic foot ulcers;
• severe hypoglycemia, diabetic ketoacidosis in the past month;
• severe visual impairment; systemic steroid therapy;
• pregnancy;
• any major life-threatening disease.

Sponsors & Collaborators

• University of Roma La Sapienza: lead
• University of Rome Foro Italico: collaborator
• University of Padova: collaborator

Study Sites (1)

Azienda Ospedaliera Sant'Andrea

Roma, RM, 00189, Italy

RECRUITING

Related Publications (20)

• Cryer PE. Hypoglycaemia: the limiting factor in the glycaemic management of Type I and Type II diabetes. Diabetologia. 2002 Jul;45(7):937-48. doi: 10.1007/s00125-002-0822-9. Epub 2002 Apr 26.

  PMID: 12136392 BACKGROUND

• McMahon SK, Ferreira LD, Ratnam N, Davey RJ, Youngs LM, Davis EA, Fournier PA, Jones TW. Glucose requirements to maintain euglycemia after moderate-intensity afternoon exercise in adolescents with type 1 diabetes are increased in a biphasic manner. J Clin Endocrinol Metab. 2007 Mar;92(3):963-8. doi: 10.1210/jc.2006-2263. Epub 2006 Nov 21.

  PMID: 17118993 BACKGROUND

• Goodyear LJ, Kahn BB. Exercise, glucose transport, and insulin sensitivity. Annu Rev Med. 1998;49:235-61. doi: 10.1146/annurev.med.49.1.235.

  PMID: 9509261 BACKGROUND

• Dohm GL. Invited review: Regulation of skeletal muscle GLUT-4 expression by exercise. J Appl Physiol (1985). 2002 Aug;93(2):782-7. doi: 10.1152/japplphysiol.01266.2001.

  PMID: 12133892 BACKGROUND

• Younk LM, Mikeladze M, Tate D, Davis SN. Exercise-related hypoglycemia in diabetes mellitus. Expert Rev Endocrinol Metab. 2011 Jan 1;6(1):93-108. doi: 10.1586/eem.10.78.

  PMID: 21339838 BACKGROUND

• van Bon AC, Verbitskiy E, von Basum G, Hoekstra JB, DeVries JH. Exercise in closed-loop control: a major hurdle. J Diabetes Sci Technol. 2011 Nov 1;5(6):1337-41. doi: 10.1177/193229681100500604.

  PMID: 22226250 BACKGROUND

• Toni S, Reali MF, Barni F, Lenzi L, Festini F. Managing insulin therapy during exercise in type 1 diabetes mellitus. Acta Biomed. 2006;77 Suppl 1:34-40.

  PMID: 16918069 BACKGROUND

• Riddell MC, Milliken J. Preventing exercise-induced hypoglycemia in type 1 diabetes using real-time continuous glucose monitoring and a new carbohydrate intake algorithm: an observational field study. Diabetes Technol Ther. 2011 Aug;13(8):819-25. doi: 10.1089/dia.2011.0052. Epub 2011 May 20.

  PMID: 21599515 BACKGROUND

• Breton M, Farret A, Bruttomesso D, Anderson S, Magni L, Patek S, Dalla Man C, Place J, Demartini S, Del Favero S, Toffanin C, Hughes-Karvetski C, Dassau E, Zisser H, Doyle FJ 3rd, De Nicolao G, Avogaro A, Cobelli C, Renard E, Kovatchev B; International Artificial Pancreas Study Group. Fully integrated artificial pancreas in type 1 diabetes: modular closed-loop glucose control maintains near normoglycemia. Diabetes. 2012 Sep;61(9):2230-7. doi: 10.2337/db11-1445. Epub 2012 Jun 11.

  PMID: 22688340 BACKGROUND

• Sherr JL, Cengiz E, Palerm CC, Clark B, Kurtz N, Roy A, Carria L, Cantwell M, Tamborlane WV, Weinzimer SA. Reduced hypoglycemia and increased time in target using closed-loop insulin delivery during nights with or without antecedent afternoon exercise in type 1 diabetes. Diabetes Care. 2013 Oct;36(10):2909-14. doi: 10.2337/dc13-0010. Epub 2013 Jun 11.

  PMID: 23757427 BACKGROUND

• Jackson M, Castle JR. Where Do We Stand with Closed-Loop Systems and Their Challenges? Diabetes Technol Ther. 2020 Jul;22(7):485-491. doi: 10.1089/dia.2019.0469. Epub 2020 May 22.

  PMID: 32069100 BACKGROUND

• Breton MD, Brown SA, Karvetski CH, Kollar L, Topchyan KA, Anderson SM, Kovatchev BP. Adding heart rate signal to a control-to-range artificial pancreas system improves the protection against hypoglycemia during exercise in type 1 diabetes. Diabetes Technol Ther. 2014 Aug;16(8):506-11. doi: 10.1089/dia.2013.0333. Epub 2014 Apr 4.

  PMID: 24702135 BACKGROUND

• Breton MD. Physical activity-the major unaccounted impediment to closed loop control. J Diabetes Sci Technol. 2008 Jan;2(1):169-74. doi: 10.1177/193229680800200127.

  PMID: 19885195 BACKGROUND

• Yardley JE, Kenny GP, Perkins BA, Riddell MC, Balaa N, Malcolm J, Boulay P, Khandwala F, Sigal RJ. Resistance versus aerobic exercise: acute effects on glycemia in type 1 diabetes. Diabetes Care. 2013 Mar;36(3):537-42. doi: 10.2337/dc12-0963. Epub 2012 Nov 19.

  PMID: 23172972 BACKGROUND

• Reddy R, Wittenberg A, Castle JR, El Youssef J, Winters-Stone K, Gillingham M, Jacobs PG. Effect of Aerobic and Resistance Exercise on Glycemic Control in Adults With Type 1 Diabetes. Can J Diabetes. 2019 Aug;43(6):406-414.e1. doi: 10.1016/j.jcjd.2018.08.193. Epub 2018 Aug 30.

  PMID: 30414785 BACKGROUND

• Guillot FH, Jacobs PG, Wilson LM, Youssef JE, Gabo VB, Branigan DL, Tyler NS, Ramsey K, Riddell MC, Castle JR. Accuracy of the Dexcom G6 Glucose Sensor during Aerobic, Resistance, and Interval Exercise in Adults with Type 1 Diabetes. Biosensors (Basel). 2020 Sep 29;10(10):138. doi: 10.3390/bios10100138.

  PMID: 33003524 BACKGROUND

• Franc S, Benhamou PY, Borot S, Chaillous L, Delemer B, Doron M, Guerci B, Hanaire H, Huneker E, Jeandidier N, Amadou C, Renard E, Reznik Y, Schaepelynck P, Simon C, Thivolet C, Thomas C, Hannaert P, Charpentier G. No more hypoglycaemia on days with physical activity and unrestricted diet when using a closed-loop system for 12 weeks: A post hoc secondary analysis of the multicentre, randomized controlled Diabeloop WP7 trial. Diabetes Obes Metab. 2021 Sep;23(9):2170-2176. doi: 10.1111/dom.14442. Epub 2021 Jun 3.

  PMID: 34009725 BACKGROUND

• Paldus B, Morrison D, Zaharieva DP, Lee MH, Jones H, Obeyesekere V, Lu J, Vogrin S, La Gerche A, McAuley SA, MacIsaac RJ, Jenkins AJ, Ward GM, Colman P, Smart CEM, Seckold R, King BR, Riddell MC, O'Neal DN. A Randomized Crossover Trial Comparing Glucose Control During Moderate-Intensity, High-Intensity, and Resistance Exercise With Hybrid Closed-Loop Insulin Delivery While Profiling Potential Additional Signals in Adults With Type 1 Diabetes. Diabetes Care. 2022 Jan 1;45(1):194-203. doi: 10.2337/dc21-1593.

  PMID: 34789504 BACKGROUND

• Riddell MC, Gallen IW, Smart CE, Taplin CE, Adolfsson P, Lumb AN, Kowalski A, Rabasa-Lhoret R, McCrimmon RJ, Hume C, Annan F, Fournier PA, Graham C, Bode B, Galassetti P, Jones TW, Millan IS, Heise T, Peters AL, Petz A, Laffel LM. Exercise management in type 1 diabetes: a consensus statement. Lancet Diabetes Endocrinol. 2017 May;5(5):377-390. doi: 10.1016/S2213-8587(17)30014-1. Epub 2017 Jan 24.

  PMID: 28126459 BACKGROUND

• Ozaslan B, Patek SD, Fabris C, Breton MD. Automatically accounting for physical activity in insulin dosing for type 1 diabetes. Comput Methods Programs Biomed. 2020 Dec;197:105757. doi: 10.1016/j.cmpb.2020.105757. Epub 2020 Sep 21.

  PMID: 33007591 BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus, Type 1; Motor Activity

Interventions

High-Intensity Interval Training; Resistance Training

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Physical Conditioning, Human; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Exercise Therapy; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities

Study Officials

• Giuseppe Pugliese

  University of Roma La Sapienza

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Giuseppe Pugliese

CONTACT

00390633775440; giuseppe.pugliese@uniroma1.it

Jonida Haxhi

CONTACT

00390633775249; jonida.haxhi@uniroma1.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: November 10, 2022
• First Posted: February 21, 2023
• Study Start: March 31, 2023
• Primary Completion: December 22, 2024
• Study Completion: December 22, 2024
• Last Updated: April 25, 2023

Record last verified: 2023-04

Locations

IT (1)