Clinical trial NCT03260868: Evaluation of Virtual Versus Traditional Study Conducted in a Group Pilot Study in Adult Patients With Type 1 Diabetes Mellitus (eStudy)
Official title: Evaluation of Virtual Versus Traditional Study Conduct in a 6-month, Multicenter, Randomized, Open-label, Two-parallel Group Pilot Study in Adult Patients With Type 1 Diabetes Mellitus
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Type 1 Diabetes Mellitus
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2017-08-24
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Change From Baseline in Glycated Hemoglobin A1c (HbA1c) to Week 24
timeFrame: Baseline, Week 24
Secondary outcomes:
measure: Change From Baseline in Glycated Hemoglobin A1c to Week 16
timeFrame: Baseline, Week 16
measure: Change From Baseline in Fasting Plasma Glucose (FPG) to Week 16 and Week 24
timeFrame: Baseline, Week 16, Week 24
measure: Participant Satisfaction With Trial Experience: Was It Worth It (WIWI) Questionnaire Response at Week 24
timeFrame: At Week 24
measure: Change From Baseline in Work Productivity and Impairment-Study Participation (WPAI-SP) Scores to Week 24
timeFrame: Baseline, Week 24
measure: Change From Baseline in Overall Study Experience-Participation (OSEP) Part-1 Questionnaire Score to Week 24
timeFrame: Baseline, Week 24
measure: Change From Baseline in Overall Study Experience-Participation Part-2 Questionnaire Score to Week 24
timeFrame: Baseline, Week 24
measure: Resource Use Questionnaire (RUQ) Scores
timeFrame: During 24 weeks treatment period
measure: Change From Baseline in Diabetes Treatment Satisfaction Questionnaire Status (DTSQs) to Week 24
timeFrame: Baseline, Week 24
measure: Change From Baseline in Diabetes Treatment Satisfaction Questionnaire Change (DTSQc) Score to Week 24
timeFrame: Baseline, Week 24
measure: Hypoglycemia Fear Survey-II (HFS-II) Scores
timeFrame: At Week 24
measure: Diabetes Distress Scale (DDS) Scores
timeFrame: Week 0, Week 24
measure: Change From Baseline in 7-Point Self-Monitoring of Plasma Glucose (SMPG) Profiles at Week 16 and Week 24 Per Time Point
timeFrame: Baseline, Week 16, Week 24
measure: Average Daily Insulin Doses
timeFrame: During 24 weeks treatment period
measure: Overall Study Experience-Sites (OSES) Questionnaire Part-1: Hours Spent by Investigator
timeFrame: During 24 weeks treatment period
measure: Overall Study Experience-Sites Questionnaire Part-2 Scores for Site-Perceived Participant Relationship and Satisfaction at Week 24
timeFrame: At Week 24
measure: Number of Participants With At Least One Hypoglycemic Events (Any, Severe Documented Symptomatic, Probable Symptomatic, Asymptomatic, Pseudo-hypoglycemia: Any Time of the Day) During 24 Week Treatment Period
timeFrame: During 24 weeks treatment period
Other outcomes:
Locations:
city: West Des Moines
country: United States
facility: Investigational Site Number 8400002
state: Iowa
city: Houston
country: United States
facility: Investigational Site Number 8400004
state: Texas
city: Bridgeport
country: United States
facility: Investigational Site Number 8400003
state: West Virginia
city: Barrie
country: Canada
facility: Investigational Site Number 1240001
city: Oakville
country: Canada
facility: Investigational Site Number 1240003
city: Thornhill
country: Canada
facility: Investigational Site Number 1240002
Study officials:
affiliation: Sanofi
name: Clinical Sciences & Operations
role: STUDY_DIRECTOR
References: