Status:
TERMINATED
Evaluation of Virtual Versus Traditional Study Conducted in a Group Pilot Study in Adult Patients With Type 1 Diabetes Mellitus (eStudy)
Lead Sponsor:
Sanofi
Conditions:
Type 1 Diabetes Mellitus
Eligibility:
All Genders
18+ years
Phase:
PHASE4
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...
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 af...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
September 19 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 22 2018
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT03260868
Start Date
September 19 2017
End Date
November 22 2018
Last Update
April 7 2022
Active Locations (6)
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1
Investigational Site Number 8400002
West Des Moines, Iowa, United States, 50265
2
Investigational Site Number 8400004
Houston, Texas, United States, 77043
3
Investigational Site Number 8400003
Bridgeport, West Virginia, United States, 26330
4
Investigational Site Number 1240001
Barrie, Canada, L4M 7G1