Recruiting

Insulin Correction Factor

Sponsor:

LMC Diabetes & Endocrinology Ltd.

Code:

NCT03057470

Conditions

Diabetes Mellitus, Type 1

Eligibility Criteria

Sex: All

Age: 18 - 55

Healthy Volunteers: Not accepted

Interventions

50% bolus insulin correction

100% bolus insulin correction

150% bolus insulin correction

0% bolus insulin correction

Study Details

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

Study ID

NCT03057470

Start date

May, 2016

Status verified date

Feb, 2017

Completion date

Mar, 2017

Anticipated

Primary completion date

Mar, 2017

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 55

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

18 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: 0% Bolus Insulin Correction

0% Bolus Insulin Correction

active comparator: 50% Bolus Insulin Correction

50% Bolus Insulin Correction

active comparator: 100% Bolus Insulin Correction

100% Bolus Insulin Correction

active comparator: 150% Bolus Insulin Correction

150% Bolus Insulin Correction

Interventions

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

0% bolus insulin correction

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

Primary outcome measure

  • Reduction In Plasma Glucose (YSI) [ Time Frame: 147 days ]

Central Contacts and Locations

Central contacts

Ronnie Aronson, MD

416-645-2929aronsonresearch@LMC.ca

Saeideh Mayanloo, BSc

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

Locations

LMC Bayview

Recruiting

Toronto, Ontario, Canada

Contacts

Ronnie Aronson, MD

416-645-2929torontoresearch@lmc.ca

More Information

Sponsor

LMC Diabetes & Endocrinology Ltd.

Last update posted

Feb 20, 2017

Last verified

Feb, 2017

Keywords

  • Diabetes
  • Exercise
  • Insulin

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by LMC Diabetes & Endocrinology Ltd. on 2017-02-20.