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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-05-31

Study Completion Date

2017-03-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Diabetes Mellitus, Type 1

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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0% Bolus Insulin Correction

Group Type ACTIVE_COMPARATOR

0% bolus insulin correction

Intervention Type OTHER

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

50% Bolus Insulin Correction

Group Type ACTIVE_COMPARATOR

50% bolus insulin correction

Intervention Type DRUG

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

100% Bolus Insulin Correction

Group Type ACTIVE_COMPARATOR

100% bolus insulin correction

Intervention Type DRUG

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

150% Bolus Insulin Correction

Group Type ACTIVE_COMPARATOR

150% bolus insulin correction

Intervention Type DRUG

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

Interventions

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50% bolus insulin correction

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

Intervention Type DRUG

100% bolus insulin correction

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

Intervention Type DRUG

150% bolus insulin correction

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

Intervention Type DRUG

0% bolus insulin correction

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

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No