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

Diabetes Mellitus, Type 1 Clinical Trial

— FIT  

Official title:

Optimal Insulin Correction Factor in Post- High Intensity Exercise Hyperglycemia in Adults With Type 1 Diabetes: The FIT Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03057470
• Other study ID #: FIT
• Status: Recruiting
• Phase: Phase 4
• First received: December 23, 2016
• Last updated: February 17, 2017
• Start date: May 2016
• Est. completion date: March 2017

Study information

• Verified date: February 2017
• Source: LMC Diabetes & Endocrinology Ltd.
• Contact: Ronnie Aronson, MD
• Phone: 416-645-2929
• Email: aronsonresearch[@]LMC.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

FIT is an open-label, repeated measures cross-over study. 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. Following a 2 week screening phase, patients will enter an 8 week transition to insulin glargine U300 (Toujeo®) if on another basal insulin, in order to optimize their insulin dose and determine their individual insulin correction factor. The final phase of the study is the intervention phase, which consists of 4 separate visits. At each visit, the patient will perform 15 minutes of high intensity exercise in the morning. If they become hyperglycemic following exercise (blood glucose >8.0 mmol/L), they will receive one of four insulin correction doses (0% 50%, 100%, or 150% of their usual correction factor) in a randomized order. They will be monitored in the clinical pharmacology unit by study staff for the rest of the day and overnight. The patient will wear a continuous glucose monitor (CGM) during each intervention visit. The primary outcome of the study is the greatest net reduction in plasma glucose (YSI) following a 50%, 100% and 150% bolus insulin correction of post-exercise hyperglycemia, compared to no bolus insulin correction. Key secondary outcomes include the mean time spent in post-exercise hyperglycemia (>8.0 mmol/L), post-exercise euglycemia (4.0-8.0 mmol/L) and post-exercise hypoglycaemia (≤ 3.9 mmol/L) within 180 minutes and 24 hours following bolus insulin correction.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 18
• Est. completion date: March 2017
• Est. primary completion date: March 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

Inclusion Criteria

• 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

Exclusion Criteria

• 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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Hyperglycemia

Intervention

Drug:
• 50% bolus insulin correction
Patients will receive 50% of their usual bolus insulin correction for post-exercise hyperglycemia
• 100% bolus insulin correction
Patients will receive 100% of their usual bolus insulin correction for post-exercise hyperglycemia
• 150% bolus insulin correction
Patients will receive 150% of their usual bolus insulin correction for post-exercise hyperglycemia

Other:
• 0% bolus insulin correction
Patients will receive no bolus insulin correction for post-exercise hyperglycemia

Locations

Country	Name	City	State
Canada	LMC Bayview	Toronto	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
LMC Diabetes & Endocrinology Ltd.	Sanofi

Country where clinical trial is conducted

Canada, 

References & Publications (1)

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reduction In Plasma Glucose (YSI)		147 days
Secondary	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