Flexible Insulin Therapy Untethered Insulin Regimen in Avidly Exercising Patients With Type 1 Diabetes: FIT Untethered

• Status: Unknown status
• Trial end date: 2019-06-30
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: LMC Diabetes & Endocrinology Ltd.
• Treatments: Insulin; Insulin, Globin Zinc; Insulin, Long-Acting

Criteria

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