Flexible Insulin Therapy Untethered Insulin Regimen in Avidly Exercising Patients With Type 1 Diabetes: FIT Untethered

NCT03838783 | Unknown Phase 4

• 1 other identifier: FIT Untethered
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

The overall objective of this study is to evaluate glycemic control and patient-reported outcomes in patients with Type 1 diabetes (T1D) who use insulin degludec and continuous subcutaneous insulin infusion in a combination untethered regimen during moderate or high-intensity exercise.

Conditions

Type 1 Diabetes Mellitus

Keywords

Exercise; Insulin Degludec; Continuous glucose monitoring (CGM); Continuous Subcutaneous Insulin Infusion (CSII)

Outcome Measures

Primary Outcomes (1)

• Time in range within 6 hours

  Percentage of time with CGM glucose between 4.0 - 10.0 mmol/L within 6 hours after the start of high-intensity or moderate-intensity, in-clinic exercise

  6 hours

Secondary Outcomes (11)

• Change in glucose within 60 mins after high-intensity exercise starts

  60 mins

• Change in glucose within 120 mins after moderate-intensity exercise starts

  120 mins

• Time spent in hypoglycemia 24 hours after exercise

  24 hours

• Time in range 24 hours after exercise

  24 hours

• Time spent in hyperglycemia 24 hours after exercise

  24 hours

Study Arms (2)

Usual CSII

NO INTERVENTION

Continue to use the established CSII insulin therapy

Untethered CSII

EXPERIMENTAL

Basal dosing - total CSII basal dose will be delivered by 50% through continuing CSII therapy used prior to study enrollment and 50% through the addition of once daily insulin degludec injected in the morning; Bolus dosing - continue the established bolus insulin dose

Drug: Insulin Degludec

Interventions

Insulin Degludec DRUG

50% of the patient's daily basal insulin dose delivered through once daily insulin degludec injected in the morning; 50% of the basal insulin to be delivered through previously established CSII

Also known as: Tresiba

Untethered CSII

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Adults with clinical diagnosis of T1D
• Age 18-55 years, inclusive
• Diagnosis of T1D ≥ 6 months
• A1c ≤ 8.5% at screening visit
• Using stable CSII therapy for ≥ 6 months
• Exercise regularly (≥ 3 times per week of moderate or vigorous exercise)
• VO2peak ≥ 30 ml/kg/min for females and ≥ 32 ml/kg/min for males
• Willing to adhere to the protocol requirements for the duration of the study
• Written informed consent
• Fasting C-peptide value of \< 0.7 ng/mL (0.23 nmol/L) at screening visit

You may not qualify if:

• Pregnant or lactating
• Already using a split regimen of combination CSII and basal insulin injection
• Active diabetic retinopathy (proliferated diabetic retinopathy, or vitreous hemorrhage in past 6 months) that could potentially be worsened by the exercise protocol
• Any evidence of unstable cardiovascular disease, disorders or abnormalities as per physician's discretion
• Currently following a very low calorie or other weight-loss diet which may impact glucose control and mask the primary and secondary outcome measures
• More than one episode of severe hypoglycemia with seizure, coma or requiring assistance of another person during the past 6 months
• Known hypoglycemia unawareness
• Use of acetaminophen (Tylenol) during the study period
• Medications other than insulin that might impact outcome measures:
• Beta blockers
• Any agents that affect hepatic glucose production, including all beta adrenergic agonists or antagonists, all xanthine derivatives
• Pramlintide
• Any non-insulin diabetes therapy

Sponsors & Collaborators

• LMC Diabetes & Endocrinology Ltd.: lead

Study Sites (1)

LMC Diabetes & Endocrinology Ltd.

Toronto, Ontario, M4G 3E8, Canada

RECRUITING

Related Publications (8)

• Doyle EA, Weinzimer SA, Steffen AT, Ahern JA, Vincent M, Tamborlane WV. A randomized, prospective trial comparing the efficacy of continuous subcutaneous insulin infusion with multiple daily injections using insulin glargine. Diabetes Care. 2004 Jul;27(7):1554-8. doi: 10.2337/diacare.27.7.1554.

  PMID: 15220227 BACKGROUND

• Binek A, Rembierz-Knoll A, Polanska J, Jarosz-Chobot P. Reasons for the discontinuation of therapy of personal insulin pump in children with type 1 diabetes. Pediatr Endocrinol Diabetes Metab. 2016 Feb 18;21(2):65-9. doi: 10.18544/PEDM-21.02.0026.

  PMID: 26901138 BACKGROUND

• Wong JC, Boyle C, DiMeglio LA, Mastrandrea LD, Abel KL, Cengiz E, Cemeroglu PA, Aleppo G, Largay JF, Foster NC, Beck RW, Adi S; T1D Exchange Clinic Network. Evaluation of Pump Discontinuation and Associated Factors in the T1D Exchange Clinic Registry. J Diabetes Sci Technol. 2017 Mar;11(2):224-232. doi: 10.1177/1932296816663963. Epub 2016 Sep 25.

  PMID: 27595711 BACKGROUND

• Benbenek-Klupa T, Matejko B, Klupa T. Metabolic control in type 1 diabetes patients practicing combat sports: at least two-year follow-up study. Springerplus. 2015 Mar 17;4:133. doi: 10.1186/s40064-015-0919-5. eCollection 2015.

  PMID: 25825689 BACKGROUND

• Delvecchio M, Zecchino C, Salzano G, Faienza MF, Cavallo L, De Luca F, Lombardo F. Effects of moderate-severe exercise on blood glucose in Type 1 diabetic adolescents treated with insulin pump or glargine insulin. J Endocrinol Invest. 2009 Jun;32(6):519-24. doi: 10.1007/BF03346499.

  PMID: 19474521 BACKGROUND

• Yardley JE, Zaharieva DP, Jarvis C, Riddell MC. The "ups" and "downs" of a bike race in people with type 1 diabetes: dramatic differences in strategies and blood glucose responses in the Paris-to-Ancaster Spring Classic. Can J Diabetes. 2015 Apr;39(2):105-10. doi: 10.1016/j.jcjd.2014.09.003. Epub 2014 Dec 6.

  PMID: 25492557 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

• Aronson R, Li A, Brown RE, McGaugh S, Riddell MC. Flexible insulin therapy with a hybrid regimen of insulin degludec and continuous subcutaneous insulin infusion with pump suspension before exercise in physically active adults with type 1 diabetes (FIT Untethered): a single-centre, open-label, proof-of-concept, randomised crossover trial. Lancet Diabetes Endocrinol. 2020 Jun;8(6):511-523. doi: 10.1016/S2213-8587(20)30114-5.

  PMID: 32445738 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 1; Motor Activity

Interventions

insulin degludec

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Ronnie Aronson, MD

CONTACT

416-645-2929; aronsonresearch@lmc.ca

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Medical Officer

Model Details: Randomization for the sequence of Interventions (A and B) will be done by an interactive system that will randomly assign patients to an intervention sequence.

Study Record Dates

• First Submitted: July 26, 2018
• First Posted: February 12, 2019
• Study Start: May 15, 2018
• Primary Completion: April 30, 2019
• Study Completion: June 30, 2019
• Last Updated: February 12, 2019

Record last verified: 2019-02

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)