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

Sanofi

Status and phase: Terminated; Phase 4

Conditions: Type 1 Diabetes Mellitus

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT03260868

U1111-1188-5647 (Other Identifier)

MSC15146

Details and patient eligibility

About

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.

Full 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.

Enrollment: 15 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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15 participants in 2 patient groups

Virtual

Experimental group

Description:

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.

Treatment:

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 group

Description:

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.

Treatment:

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

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