Status:
UNKNOWN
Flexible Insulin Therapy Untethered Insulin Regimen in Avidly Exercising Patients With Type 1 Diabetes: FIT Untethered
Lead Sponsor:
LMC Diabetes & Endocrinology Ltd.
Conditions:
Type 1 Diabetes Mellitus
Eligibility:
All Genders
18-55 years
Phase:
PHASE4
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 in...
Detailed Description
FIT untethered is an open-label, randomized, repeated measures cross-over design study, testing glycemic control in "untethered" continuous subcutaneous insulin infusion (CSII) therapy compared to usu...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 15 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 30 2019
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT03838783
Start Date
May 15 2018
End Date
June 30 2019
Last Update
February 12 2019
Active Locations (1)
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1
LMC Diabetes & Endocrinology Ltd.
Toronto, Ontario, Canada, M4G 3E8