Recruiting

FIT Untethered

Sponsor:

LMC Diabetes & Endocrinology Ltd.

Code:

NCT03838783

Conditions

Type 1 Diabetes Mellitus

Eligibility Criteria

Sex: All

Age: 18 - 55

Healthy Volunteers: Not accepted

Interventions

Insulin Degludec

Study Details

Brief summary:

The overall objective of this study is to evaluate glycemic control and patient-reported outcomes in patients with Type 1 diabetes (T1D) who use insulin degludec and continuous subcutaneous insulin infusion in a combination untethered regimen during moderate or high-intensity exercise.

Conditions

Type 1 Diabetes Mellitus

Study ID

NCT03838783

Start date

May 15, 2018

Status verified date

Feb, 2019

Completion date

Jun 30, 2019

Anticipated

Primary completion date

Apr 30, 2019

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 55

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Adults with clinical diagnosis of T1D
  • Age 18-55 years, inclusive
  • Diagnosis of T1D ≥ 6 months
  • A1c ≤ 8.5% at screening visit
  • Using stable CSII therapy for ≥ 6 months
  • Exercise regularly (≥ 3 times per week of moderate or vigorous exercise)
  • VO2peak ≥ 30 ml/kg/min for females and ≥ 32 ml/kg/min for males
  • Willing to adhere to the protocol requirements for the duration of the study
  • Written informed consent
  • Fasting C-peptide value of < 0.7 ng/mL (0.23 nmol/L) at screening visit

Exclusion Criteria:

  • Pregnant or lactating
  • Already using a split regimen of combination CSII and basal insulin injection
  • Active diabetic retinopathy (proliferated diabetic retinopathy, or vitreous hemorrhage 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 study period
  • Medications other than insulin that might impact outcome measures:

  • Beta blockers
  • Any agents that affect hepatic glucose production, including all beta adrenergic agonists or antagonists, all xanthine derivatives
  • Pramlintide
  • Any non-insulin diabetes therapy

Study Design

Enrollment

30 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

no intervention: Usual CSII

Continue to use the established CSII insulin therapy

experimental: Untethered CSII

Basal dosing - total CSII basal dose will be delivered by 50% through continuing CSII therapy used prior to study enrollment and 50% through the addition of once daily insulin degludec injected in the morning; Bolus dosing - continue the established bolus insulin dose

Interventions

Insulin Degludec

50% of the patient's daily basal insulin dose delivered through once daily insulin degludec injected in the morning; 50% of the basal insulin to be delivered through previously established CSII

Primary outcome measure

  • Time in range within 6 hours [ Time Frame: 6 hours ]

Central Contacts and Locations

Central contacts

Ronnie Aronson, MD

416-645-2929aronsonresearch@lmc.ca

Locations

LMC Diabetes & Endocrinology Ltd.

Recruiting

Toronto, Ontario, Canada, M4G 3E8

More Information

Sponsor

LMC Diabetes & Endocrinology Ltd.

Last update posted

Feb 12, 2019

Last verified

Feb, 2019

Keywords

  • Exercise
  • Insulin Degludec
  • Continuous glucose monitoring (CGM)
  • Continuous Subcutaneous Insulin Infusion (CSII)

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 2019-02-12.