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

NCT ID: NCT03260868

Last Updated: 2022-04-07

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE4
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-09-19
• Study Completion Date: 2018-11-22

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.

Detailed Description

The study had a maximum study duration of 29 weeks, which consisted of a 3-week screening period (including a possible 1-week delay in first investigational medicinal product [IMP] administration after randomization in virtual group due to shipment of IMP and the virtual devices), a 24-week treatment period, and 1-week post-treatment safety follow-up period.

Conditions

Type 1 Diabetes Mellitus

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Virtual

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.

Group Type: EXPERIMENTAL

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

Intervention Type: 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).

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

Intervention Type: DRUG

Subcutaneous injection.

Traditional

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.

Group Type: ACTIVE_COMPARATOR

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

Intervention Type: 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).

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

Intervention Type: DRUG

Subcutaneous injection.

Interventions

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

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).

Intervention Type: DRUG

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

Subcutaneous injection.

Intervention Type: DRUG

Other Intervention Names

Toujeo ®

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sanofi

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Clinical Sciences & Operations

Role: STUDY_DIRECTOR

Sanofi

Locations

Investigational Site Number 8400002

West Des Moines, Iowa, United States

Investigational Site Number 8400004

Houston, Texas, United States

Investigational Site Number 8400003

Bridgeport, West Virginia, United States

Investigational Site Number 1240001

Barrie, , Canada

Investigational Site Number 1240003

Oakville, , Canada

Investigational Site Number 1240002

Thornhill, , Canada

Countries

United States; Canada

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

U1111-1188-5647

Identifier Type: OTHER

Identifier Source: secondary_id

MSC15146

Identifier Type: -

Identifier Source: org_study_id