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

Phase 4

• Conditions: Diabetes Mellitus, Type 1
• Interventions: Other: 0% bolus insulin correction; Drug: 50% bolus insulin correction; Drug: 100% bolus insulin correction; Drug: 150% bolus insulin correction

• Registration Number: NCT03057470
• Lead Sponsor: LMC Diabetes & Endocrinology Ltd.

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.

Study Timeline

• Study Start: 2016-05
• Study First Submitted: 2016-12-23
• Status Verified: 2017-02
• Study First Submitted QC: 2017-02-17
• Last Update Submitted: 2017-02-17
• Study First Posted: 2017-02-20
• Last Update Posted: 2017-02-20
• Primary Completion: 2017-03
• Study Completion: 2017-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 18

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
0% Bolus Insulin Correction	0% bolus insulin correction	0% Bolus Insulin Correction
50% Bolus Insulin Correction	50% bolus insulin correction	50% Bolus Insulin Correction
100% Bolus Insulin Correction	100% bolus insulin correction	100% Bolus Insulin Correction
150% Bolus Insulin Correction	150% bolus insulin correction	150% Bolus Insulin Correction

Primary Outcome Measures

Name	Time	Method
Reduction In Plasma Glucose (YSI)	147 days

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

LMC Bayview; 🇨🇦 Toronto, Ontario, Canada