Evaluation of Virtual Versus Traditional Study Conducted in a Group Pilot Study in Adult Patients With Type 1 Diabetes Mellitus (eStudy)

NCT03260868 | Terminated Phase 4 Results FDA Drug

• 2 other identifiers: MSC15146U1111-1188-5647
• Study Type: interventional
• Target: 15
• Locations: 2 countries
• Sites: 6

Brief Summary

Primary Objective: To evaluate the effect of virtual approach via novel technologies versus traditional study conduct on glycemic control in terms of glycated hemoglobin (HbA1c). Secondary Objective: To evaluate the appropriate utilization of virtual approach via novel technologies during the study and to assess the effect of the virtual versus traditional study conduct on multiple outcomes in terms of study methodology and diabetes management.

Conditions

Type 1 Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in Glycated Hemoglobin A1c (HbA1c) to Week 24

  Change in HbA1c was calculated by subtracting baseline value from Week 24 value.

  Baseline, Week 24

Secondary Outcomes (16)

• Change From Baseline in Glycated Hemoglobin A1c to Week 16

  Baseline, Week 16

• Change From Baseline in Fasting Plasma Glucose (FPG) to Week 16 and Week 24

  Baseline, Week 16, Week 24

• Participant Satisfaction With Trial Experience: Was It Worth It (WIWI) Questionnaire Response at Week 24

  At Week 24

• Change From Baseline in Work Productivity and Impairment-Study Participation (WPAI-SP) Scores to Week 24

  Baseline, Week 24

• Change From Baseline in Overall Study Experience-Participation (OSEP) Part-1 Questionnaire Score to Week 24

  Baseline, Week 24

Study Arms (2)

Virtual

EXPERIMENTAL

Participants included in this virtual trial approach group did not visit the study sites during the study course. All study assessments, including vital signs, weight, laboratory variables, etc., were completed via the Bluetooth devices that instantly transfer the digital data.

Drug: Insulin glargine, 300 units per milliliter (U/mL); Drug: Background therapy: Rapid Acting meal time insulin analogs (Humalog, Novolog or Apidra)

Traditional

ACTIVE COMPARATOR

Participants included in this traditional trial approach group visited the study site, followed the study visit schedules for all study assessments that was performed either in-person or phone visits.

Drug: Insulin glargine, 300 units per milliliter (U/mL); Drug: Background therapy: Rapid Acting meal time insulin analogs (Humalog, Novolog or Apidra)

Interventions

Insulin glargine, 300 units per milliliter (U/mL) DRUG

Self-administered subcutaneous injection using prefilled pen once daily for 24 weeks. Dose titration to achieve fasting self-monitoring of plasma glucose (SMPG) level between 80 and 130 milligram per deciliter (mg/dL).

Also known as: Toujeo ®

Traditional; Virtual

Background therapy: Rapid Acting meal time insulin analogs (Humalog, Novolog or Apidra) DRUG

Subcutaneous injection.

Traditional; Virtual

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants with Type 1 diabetes mellitus (T1DM) diagnosed at least one year before the screening visit.
• Participants who were treated with multi-dose insulin using insulin glargine 100 U/mL (eg, Lantus or Basaglar) as basal insulin and rapid acting insulin analogues as bolus insulin.
• Participants with access to or experience with mobile technology (eg, tablet or smart phone).
• eSign the consent on the study web portal.

You may not qualify if:

• Age less than (\<) 18 years at screening (Visit 1 - Step 1).
• Type 2 diabetes mellitus.
• HbA1c \<5.4 percent (%) or greater than or equal to (\>=) 9.0% measured by the central lab at Visit 1.
• Participants who received \<6 months treatment with any basal plus (+) meal-time insulin.
• Use of any basal insulins other than insulin glargine 100 U/mL (eg, Lantus or Basaglar) within 3 months before screening.
• Use of an insulin pump within 6 months before screening.
• Use of meal-time insulin other than rapid-acting insulin analogs (Humalog, Novolog, or Apidra), eg, human regular insulin, within 30 days before screening.
• Hemoglobinopathy resulting in undetectable HbA1c by the central laboratory, or hemolytic anemia requiring transfusion of blood or plasma products within 3 months before screening.
• Participants experienced with any severe hypoglycemic episode resulting in seizure, unconsciousness, or coma, and/or leading to hospitalization during the past 6 months before screening.
• Participants with insufficient smart phone skills or unwilling to properly use the virtual tools deemed by the investigator based on the observation and experiences over the digital screening procedure-Mental disorders or any neurologic disorder that would affect participant's ability to meet the study requirements, or participants deemed unlikely to safely manage insulin dosage by the investigator.
• Known hypersensitivity/intolerance to insulin glargine, rapid-acting insulin analogs or any of their excipients.
• Pregnant or breast-feeding women, or women who intend to become pregnant during the study period.
• The above information was not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.

Sponsors & Collaborators

• Sanofi: lead

Study Sites (6)

Investigational Site Number 8400002

West Des Moines, Iowa, 50265, United States

Location

Investigational Site Number 8400004

Houston, Texas, 77043, United States

Location

Investigational Site Number 8400003

Bridgeport, West Virginia, 26330, United States

Location

Investigational Site Number 1240001

Barrie, L4M 7G1, Canada

Location

Investigational Site Number 1240003

Oakville, L6M 1M1, Canada

Location

Investigational Site Number 1240002

Thornhill, L4J 8L7, Canada

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Interventions

Insulin Glargine; Insulin Lispro; Insulin Aspart; insulin glulisine

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Insulin, Long-Acting; Insulins; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins; Insulin, Short-Acting

Limitations and Caveats

Planned analysis could not be performed due to early study termination.

Results Point of Contact

• Title: Trial Transparency Team
• Organization: Sanofi

Contact-US@sanofi.com

800-633-1610

Study Officials

• Clinical Sciences & Operations

  Sanofi

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 14, 2017
• First Posted: August 24, 2017
• Study Start: September 19, 2017
• Primary Completion: November 22, 2018
• Study Completion: November 22, 2018
• Last Updated: April 7, 2022
• Results First Posted: January 7, 2020

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will share

Locations

US (3); CA (3)