Optimal Insulin Correction Factor in Post- High Intensity Exercise Hyperglycemia in Adults With Type 1 Diabetes (FIT)

NCT03057470 | Unknown Phase 4

• 1 other identifier: FIT
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

The overall objective of this study is to investigate the glycemic response of a 0%, 50%, 100% and 150% bolus insulin correction (based on personal insulin correction factor) of post-exercise hyperglycemia in physically active adults with type 1 diabetes (T1D) using multiple daily injections (MDI) in a controlled, but clinically representative, experimental setting.

Conditions

Diabetes Mellitus, Type 1

Keywords

Diabetes; Exercise; Insulin

Outcome Measures

Primary Outcomes (1)

• Reduction In Plasma Glucose (YSI)

  147 days

Secondary Outcomes (1)

• Investigate Glycemic Response of a 0%, 50%, 100% and 150% Bolus Insulin Correction of Post-exercise Hyperglycemia Compared to no Bolus Insulin Correction

  147 days

Study Arms (4)

0% Bolus Insulin Correction

ACTIVE COMPARATOR

0% Bolus Insulin Correction

Other: 0% bolus insulin correction

50% Bolus Insulin Correction

ACTIVE COMPARATOR

50% Bolus Insulin Correction

Drug: 50% bolus insulin correction

100% Bolus Insulin Correction

ACTIVE COMPARATOR

100% Bolus Insulin Correction

Drug: 100% bolus insulin correction

150% Bolus Insulin Correction

ACTIVE COMPARATOR

150% Bolus Insulin Correction

Drug: 150% bolus insulin correction

Interventions

50% bolus insulin correction DRUG

Patients will receive 50% of their usual bolus insulin correction for post-exercise hyperglycemia

50% Bolus Insulin Correction

100% bolus insulin correction DRUG

Patients will receive 100% of their usual bolus insulin correction for post-exercise hyperglycemia

100% Bolus Insulin Correction

150% bolus insulin correction DRUG

Patients will receive 150% of their usual bolus insulin correction for post-exercise hyperglycemia

150% Bolus Insulin Correction

0% bolus insulin correction OTHER

Patients will receive no bolus insulin correction for post-exercise hyperglycemia

0% Bolus Insulin Correction

Eligibility Criteria

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

You may qualify if:

• Male or female
• Clinical diagnosis of presumed autoimmune T1D
• Age 18-55 years, inclusive
• Duration of T1D ≥ 6 months
• Using MDI therapy for at least 6 months
• Fasting C-peptide value of \< 0.7 ng/mL (0.23 nmol/L) at screening visit
• Patient must be willing to undergo an 8-week run-in phase prior to the study period where they will be required to use MDI therapy at least 4 times per day, and switch from their usual basal insulin to insulin glargine U300
• Exercise regularly: i.e. ≥ 30 minutes of moderate or vigorous aerobic activity ≥ 3 times/week for a minimum of 90 minutes weekly
• VO2peak ≥32 ml/kg/min for females and ≥ 35 ml/kg/min for males
• HbA1c between 6.0-9.0% inclusive at screening visit.
• Insulin total daily dose (TDD) ≥ 30 U/day
• In good general health with no known conditions that could influence the outcome of the trial, and in the judgement of the Investigator is a good candidate for the study based on review of available medical history, physical examination and clinical laboratory evaluations
• Willing to adhere to the protocol requirements for the duration of the study

You may not qualify if:

• Pregnant or lactating
• Active diabetic retinopathy (proliferative diabetic retinopathy, or vitreous haemorrhage 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 run-in phase or study period
• Medications other than insulin that might impact outcome measures:
• Beta blockers
• Agents that affect hepatic glucose production such as beta adrenergic agonists and antagonists, xanthine derivatives
• Pramlintide
• Any non-insulin diabetes therapy

Sponsors & Collaborators

• LMC Diabetes & Endocrinology Ltd.: lead
• Sanofi: collaborator

Study Sites (1)

LMC Bayview

Toronto, Ontario, Canada

RECRUITING

Related Publications (3)

• 1. Robertson K, Adolfsson P, Scheiner G, Hanas R, Riddell M. Exercise in children and adolescents with diabetes. Pediatric diabetes. 2009;10(Journal Article):154. 2. Wasserman DH, Zinman B. Exercise in individuals with IDDM. Diabetes Care. 1994;17(8):924-937. 3. Galassetti P, Riddell MC. Exercise and type 1 diabetes (T1DM). Compr Physiol. 2013;3(3):1309-1336. 4. Zaharieva DP, Riddell MC. Prevention of exercise-associated dysglycemia: a case study-based approach. Diabetes Spectr. 2015;28(1):55-62. 5. Pivovarov JA, Taplin CE, Riddell MC. Current perspectives on physical activity and exercise for youth with diabetes. Pediatr Diabetes. 2015. 6. Marliss EB, Vranic M. Intense exercise has unique effects on both insulin release and its roles in glucoregulation: implications for diabetes. Diabetes. 2002;51 Suppl 1:S271-283. 7. Fahey AJ, Paramalingam N, Davey RJ, Davis EA, Jones TW, Fournier PA. The effect of a short sprint on postexercise whole-body glucose production and utilization rates in individuals with type 1 diabetes mellitus. J Clin Endocrinol Metab. 2012;97(11):4193-4200. 8. 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;4:133. 9. Iscoe KE, Riddell MC. Continuous moderate-intensity exercise with or without intermittent high-intensity work: effects on acute and late glycaemia in athletes with Type 1 diabetes mellitus. Diabetic Med. 2011;28(7):824-832. 10. Graveling AJ, Frier BM. Risks of marathon running and hypoglycaemia in Type 1 diabetes. Diabet Med. 2010;27(5):585-588. 11. Tanenberg RJ, Newton CA, Drake AJ. Confirmation of hypoglycemia in the

  BACKGROUND

• Potashner D, Brown RE, Li A, Riddell MC, Aronson R. Paradoxical Rise in Hypoglycemia Symptoms With Development of Hyperglycemia During High-Intensity Interval Training in Type 1 Diabetes. Diabetes Care. 2019 Oct;42(10):2011-2014. doi: 10.2337/dc19-0609. Epub 2019 Aug 7.

  PMID: 31391201 DERIVED

• Aronson R, Brown RE, Li A, Riddell MC. Optimal Insulin Correction Factor in Post-High-Intensity Exercise Hyperglycemia in Adults With Type 1 Diabetes: The FIT Study. Diabetes Care. 2019 Jan;42(1):10-16. doi: 10.2337/dc18-1475. Epub 2018 Nov 19.

  PMID: 30455336 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 1; Diabetes Mellitus; Motor Activity; Insulin Resistance

Condition Hierarchy (Ancestors)

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

Study Officials

• Ronnie Aronson, MD

  LMC Diabetes & Endocrinology

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ronnie Aronson, MD

CONTACT

416-645-2929; aronsonresearch@LMC.ca

Saeideh Mayanloo, BSc

CONTACT

416-645-2929; saeideh.mayanloo@LMC.ca

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 23, 2016
• First Posted: February 20, 2017
• Study Start: May 1, 2016
• Primary Completion: March 1, 2017
• Study Completion: March 1, 2017
• Last Updated: February 20, 2017

Record last verified: 2017-02

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)