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

Primary Purpose

Diabetes Mellitus, Type 1

Status

Unknown status

Phase

Phase 4

Locations

Canada

Study Type

Interventional

Intervention

50% bolus insulin correction

100% bolus insulin correction

150% bolus insulin correction

0% bolus insulin correction

About this trial

This is an interventional treatment trial for Diabetes Mellitus, Type 1 focused on measuring Diabetes, Exercise, Insulin

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

LMC BayviewRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Arm Label

0% Bolus Insulin Correction

50% Bolus Insulin Correction

100% Bolus Insulin Correction

150% Bolus Insulin Correction

Arm Description

0% Bolus Insulin Correction

50% Bolus Insulin Correction

100% Bolus Insulin Correction

150% Bolus Insulin Correction

Outcomes

Primary Outcome Measures

Reduction In Plasma Glucose (YSI)

Secondary Outcome Measures

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

Full Information

NCT ID

NCT03057470

First Posted

December 23, 2016

Last Updated

February 17, 2017

Sponsor

LMC Diabetes & Endocrinology Ltd.

Collaborators

Sanofi

1. Study Identification

Unique Protocol Identification Number

NCT03057470

Brief Title

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

Acronym

FIT

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2017

Overall Recruitment Status

Unknown status

Study Start Date

May 2016 (undefined)

Primary Completion Date

March 2017 (Anticipated)

Study Completion Date

March 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

LMC Diabetes & Endocrinology Ltd.

Collaborators

Sanofi

4. Oversight

Data Monitoring Committee

5. Study Description

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.

Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Diabetes Mellitus, Type 1

Keywords

Diabetes, Exercise, Insulin

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Crossover Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

18 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

0% Bolus Insulin Correction

Arm Type

Active Comparator

Arm Description

0% Bolus Insulin Correction

Arm Title

50% Bolus Insulin Correction

Arm Type

Active Comparator

Arm Description

50% Bolus Insulin Correction

Arm Title

100% Bolus Insulin Correction

Arm Type

Active Comparator

Arm Description

100% Bolus Insulin Correction

Arm Title

150% Bolus Insulin Correction

Arm Type

Active Comparator

Arm Description

150% Bolus Insulin Correction

Intervention Type

Drug

Intervention Name(s)

50% bolus insulin correction

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

100% bolus insulin correction

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

150% bolus insulin correction

Intervention Description

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

Intervention Type

Other

Intervention Name(s)

0% bolus insulin correction

Intervention Description

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

Primary Outcome Measure Information:

Title

Reduction In Plasma Glucose (YSI)

Time Frame

147 days

Secondary Outcome Measure Information:

Title

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

Time Frame

147 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

55 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Ronnie Aronson, MD

Phone

416-645-2929

aronsonresearch@LMC.ca

First Name & Middle Initial & Last Name or Official Title & Degree

Saeideh Mayanloo, BSc

Phone

416-645-2929

Ext

9330

saeideh.mayanloo@LMC.ca

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Ronnie Aronson, MD

Organizational Affiliation

LMC Diabetes & Endocrinology

Official's Role

Principal Investigator

Facility Information:

Facility Name

LMC Bayview

City

Toronto

State/Province

Ontario

Country

Canada

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Ronnie Aronson, MD

Phone

416-645-2929

torontoresearch@lmc.ca

12. IPD Sharing Statement

Plan to Share IPD

IPD Sharing Plan Description

Only overall study data will be shared

Citations:

Citation

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

Results Reference

background

PubMed Identifier

31391201

Citation

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.

Results Reference

derived

PubMed Identifier

30455336

Citation

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.

Results Reference

derived

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

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