Back to resultsEvaluation of Virtual Versus Traditional Study Conducted in a Group Pilot Study in Adult Patients With Type 1 Diabetes Mellitus (eStudy)
Primary Purpose
Type 1 Diabetes Mellitus
Status
Terminated
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
Insulin glargine, 300 units per milliliter (U/mL)
Background therapy: Rapid Acting meal time insulin analogs (Humalog, Novolog or Apidra)
Sponsored by
About this trial
This is an interventional treatment trial for Type 1 Diabetes Mellitus
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.
Sites / Locations
- Investigational Site Number 8400002
- Investigational Site Number 8400004
- Investigational Site Number 8400003
- Investigational Site Number 1240001
- Investigational Site Number 1240003
- Investigational Site Number 1240002
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Virtual
Traditional
Arm 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.
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.
Outcomes
Primary Outcome Measures
Change From Baseline in Glycated Hemoglobin A1c (HbA1c) to Week 24
Change in HbA1c was calculated by subtracting baseline value from Week 24 value.
Secondary Outcome Measures
Change From Baseline in Glycated Hemoglobin A1c to Week 16
Change in HbA1c was calculated by subtracting baseline value from Week 16 value.
Change From Baseline in Fasting Plasma Glucose (FPG) to Week 16 and Week 24
Change in FPG was calculated by subtracting baseline value from Week 16 value (for change at Week 16) and Week 24 (for change at Week 24) value.
Participant Satisfaction With Trial Experience: Was It Worth It (WIWI) Questionnaire Response at Week 24
Participant satisfaction with trial experience was measured using the WIWI questionnaire. The WIWI had 5 questions, 3 questions with level categorical response (Yes, No, and Unsure) scale, 1 question with 3 possible answers as: Better than I expected/The same as I expected/Worse than I expected, and 1 question with 3 possible answers: It improved/Stayed the same/Become worse.
Change From Baseline in Work Productivity and Impairment-Study Participation (WPAI-SP) Scores to Week 24
Effect of trial on a participants' ability to work and perform regular activities were measured using WPAI-SP. WPAI-SP had 6 items scored separately, where higher score indicated greater impairment and less productivity.
Change From Baseline in Overall Study Experience-Participation (OSEP) Part-1 Questionnaire Score to Week 24
Participant burden with trial participation was measured using the OSEP Questionnaire, administered electronically. OSEP Part-1 contained 4 items to examine perceptions of study participation. Each item was measured on an 11 point scale ranged from 0 (completely disagree) to 10 (completely agree), where higher score indicated higher perception of diabetes control.
Change From Baseline in Overall Study Experience-Participation Part-2 Questionnaire Score to Week 24
Participant burden with trial participation was measured using the OSEP Questionnaire, administered electronically. OSEP Part-2 contained 9 items to examine perceptions of study participation. Each item was measured on an 11 point scale ranged from 0 (completely disagree) to 10 (completely agree), where higher score indicated higher burden with trial participation.
Resource Use Questionnaire (RUQ) Scores
Healthcare resource use was measured using the RUQ which asked participants to report the resources used (time and expenses) during the previous 4 weeks in terms of visits to healthcare professionals.
Change From Baseline in Diabetes Treatment Satisfaction Questionnaire Status (DTSQs) to Week 24
The DTSQs was a validated questionnaire to assess participant's satisfaction with their diabetes treatment. It consisted of 8 items that were answered on a Likert scale from 0 (no satisfaction) to 6 (high satisfaction with treatment). Total treatment satisfaction score was the sum of items 1, 4-8 scores and ranged from 0 (no satisfaction) to 36 (high satisfaction with treatment).
Change From Baseline in Diabetes Treatment Satisfaction Questionnaire Change (DTSQc) Score to Week 24
DTSQc measured the relative change in treatment satisfaction from previous therapy. It consists of 8 items that were answered on a 6 point scale ranges from 3 (much less satisfied) to -3 (much more satisfied). Total treatment satisfaction score was the sum of items 1, 4-8 scores and ranged from -18 (much less satisfied) to +18 (much more satisfied), higher score indicated more satisfaction.
Hypoglycemia Fear Survey-II (HFS-II) Scores
Fear of hypoglycemia was measured with HFS-II at Week 24. The HFS-II comprises 33 items: 15 items explore behaviors that participants were engaged in to avoid low blood sugar and its negative consequences and 18 items related to concern/worry that participants had about their hypoglycemia. Responses to each item were made on a 5-point Likert scale ranges from 0 equal (=) "Never" to 4 = "Always". Total HFS mean score was determined by computing the mean of all 33 items and the score ranged from 0 to 4, where higher score indicated more fear/worry.
Diabetes Distress Scale (DDS) Scores
Diabetes-related distress was measured using DDS. The DDS contained 17 items related to potential problem areas that people with diabetes may experience. Participants were asked to consider the degree to which each of the items might have distressed or bothered them during the past month, and respond for each item on a 7 point scale ranges from 1 (not a problem) to 6 (a very serious problem), higher score indicated more diabetes related distress.
Change From Baseline in 7-Point Self-Monitoring of Plasma Glucose (SMPG) Profiles at Week 16 and Week 24 Per Time Point
7-point SMPG profiles were measured at the following 7 points at each visit (Baseline, Week 16, and Week 24): before breakfast, 2 hours after breakfast, before lunch, 2 hours after lunch, before dinner, 2 hours after dinner, and bedtime. For each time point, the value at each visit was calculated as the average of values obtained for the same time point across profiles performed in the week before the visit.
Average Daily Insulin Doses
Average daily insulin doses included basal insulin doses, mealtime insulin doses, and total insulin doses.
Overall Study Experience-Sites (OSES) Questionnaire Part-1: Hours Spent by Investigator
An OSES questionnaire was completed by Site Investigator and had 2 parts. The OSES Part-1 contained quantitative 1 item (question) to examine resource requirements which was: Approximately how much time did you spend with this participant (in person or via phone) during this scheduled visit/communication? (hours)
Overall Study Experience-Sites Questionnaire Part-2 Scores for Site-Perceived Participant Relationship and Satisfaction at Week 24
An OSES questionnaire was completed by site investigator and had two parts. OSES Part-2 contains 2 items to examine investigator-participant relationship and satisfaction with care. Both items were assessed on a scale of 0 [completely disagree] to 10 [completely agree]), where highest score indicated a good relationship and satisfaction with care.
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
Severe hypoglycemia was an event in which the participant required the assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions. Documented symptomatic hypoglycemia: an event during which typical symptoms of hypoglycemia were accompanied by a measured plasma glucose concentration of <=3.9 mmol/L (70 mg/dL) or <3.0 mmol/L (54 mg/dL). Asymptomatic hypoglycemia: an event not accompanied by typical symptoms of hypoglycemia but with a measured plasma glucose concentration <=3.9 mmol/L (70 mg/dL) or <3.0 mmol/L (54 mg/dL). Probable symptomatic hypoglycemia: an event during which symptoms of hypoglycemia were not accompanied by plasma glucose determination but was presumably caused by a plasma glucose concentration. Pseudo-hypoglycemia: an event with any of the typical symptoms of hypoglycaemia with plasma glucose concentration >3.9 mmol/L (70 mg/dL).
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03260868
Brief Title
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
2. Study Status
Record Verification Date
March 2022
Overall Recruitment Status
Terminated
Why Stopped
Due to "prolonged low participant recruitment"
Study Start Date
September 19, 2017 (Actual)
Primary Completion Date
November 22, 2018 (Actual)
Study Completion Date
November 22, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sanofi
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 1 Diabetes Mellitus
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
15 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Virtual
Arm Type
Experimental
Arm 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.
Arm Title
Traditional
Arm Type
Active Comparator
Arm 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.
Intervention Type
Drug
Intervention Name(s)
Insulin glargine, 300 units per milliliter (U/mL)
Other Intervention Name(s)
Toujeo ®
Intervention Description
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
Intervention Name(s)
Background therapy: Rapid Acting meal time insulin analogs (Humalog, Novolog or Apidra)
Intervention Description
Subcutaneous injection.
Primary Outcome Measure Information:
Title
Change From Baseline in Glycated Hemoglobin A1c (HbA1c) to Week 24
Description
Change in HbA1c was calculated by subtracting baseline value from Week 24 value.
Time Frame
Baseline, Week 24
Secondary Outcome Measure Information:
Title
Change From Baseline in Glycated Hemoglobin A1c to Week 16
Description
Change in HbA1c was calculated by subtracting baseline value from Week 16 value.
Time Frame
Baseline, Week 16
Title
Change From Baseline in Fasting Plasma Glucose (FPG) to Week 16 and Week 24
Description
Change in FPG was calculated by subtracting baseline value from Week 16 value (for change at Week 16) and Week 24 (for change at Week 24) value.
Time Frame
Baseline, Week 16, Week 24
Title
Participant Satisfaction With Trial Experience: Was It Worth It (WIWI) Questionnaire Response at Week 24
Description
Participant satisfaction with trial experience was measured using the WIWI questionnaire. The WIWI had 5 questions, 3 questions with level categorical response (Yes, No, and Unsure) scale, 1 question with 3 possible answers as: Better than I expected/The same as I expected/Worse than I expected, and 1 question with 3 possible answers: It improved/Stayed the same/Become worse.
Time Frame
At Week 24
Title
Change From Baseline in Work Productivity and Impairment-Study Participation (WPAI-SP) Scores to Week 24
Description
Effect of trial on a participants' ability to work and perform regular activities were measured using WPAI-SP. WPAI-SP had 6 items scored separately, where higher score indicated greater impairment and less productivity.
Time Frame
Baseline, Week 24
Title
Change From Baseline in Overall Study Experience-Participation (OSEP) Part-1 Questionnaire Score to Week 24
Description
Participant burden with trial participation was measured using the OSEP Questionnaire, administered electronically. OSEP Part-1 contained 4 items to examine perceptions of study participation. Each item was measured on an 11 point scale ranged from 0 (completely disagree) to 10 (completely agree), where higher score indicated higher perception of diabetes control.
Time Frame
Baseline, Week 24
Title
Change From Baseline in Overall Study Experience-Participation Part-2 Questionnaire Score to Week 24
Description
Participant burden with trial participation was measured using the OSEP Questionnaire, administered electronically. OSEP Part-2 contained 9 items to examine perceptions of study participation. Each item was measured on an 11 point scale ranged from 0 (completely disagree) to 10 (completely agree), where higher score indicated higher burden with trial participation.
Time Frame
Baseline, Week 24
Title
Resource Use Questionnaire (RUQ) Scores
Description
Healthcare resource use was measured using the RUQ which asked participants to report the resources used (time and expenses) during the previous 4 weeks in terms of visits to healthcare professionals.
Time Frame
During 24 weeks treatment period
Title
Change From Baseline in Diabetes Treatment Satisfaction Questionnaire Status (DTSQs) to Week 24
Description
The DTSQs was a validated questionnaire to assess participant's satisfaction with their diabetes treatment. It consisted of 8 items that were answered on a Likert scale from 0 (no satisfaction) to 6 (high satisfaction with treatment). Total treatment satisfaction score was the sum of items 1, 4-8 scores and ranged from 0 (no satisfaction) to 36 (high satisfaction with treatment).
Time Frame
Baseline, Week 24
Title
Change From Baseline in Diabetes Treatment Satisfaction Questionnaire Change (DTSQc) Score to Week 24
Description
DTSQc measured the relative change in treatment satisfaction from previous therapy. It consists of 8 items that were answered on a 6 point scale ranges from 3 (much less satisfied) to -3 (much more satisfied). Total treatment satisfaction score was the sum of items 1, 4-8 scores and ranged from -18 (much less satisfied) to +18 (much more satisfied), higher score indicated more satisfaction.
Time Frame
Baseline, Week 24
Title
Hypoglycemia Fear Survey-II (HFS-II) Scores
Description
Fear of hypoglycemia was measured with HFS-II at Week 24. The HFS-II comprises 33 items: 15 items explore behaviors that participants were engaged in to avoid low blood sugar and its negative consequences and 18 items related to concern/worry that participants had about their hypoglycemia. Responses to each item were made on a 5-point Likert scale ranges from 0 equal (=) "Never" to 4 = "Always". Total HFS mean score was determined by computing the mean of all 33 items and the score ranged from 0 to 4, where higher score indicated more fear/worry.
Time Frame
At Week 24
Title
Diabetes Distress Scale (DDS) Scores
Description
Diabetes-related distress was measured using DDS. The DDS contained 17 items related to potential problem areas that people with diabetes may experience. Participants were asked to consider the degree to which each of the items might have distressed or bothered them during the past month, and respond for each item on a 7 point scale ranges from 1 (not a problem) to 6 (a very serious problem), higher score indicated more diabetes related distress.
Time Frame
Week 0, Week 24
Title
Change From Baseline in 7-Point Self-Monitoring of Plasma Glucose (SMPG) Profiles at Week 16 and Week 24 Per Time Point
Description
7-point SMPG profiles were measured at the following 7 points at each visit (Baseline, Week 16, and Week 24): before breakfast, 2 hours after breakfast, before lunch, 2 hours after lunch, before dinner, 2 hours after dinner, and bedtime. For each time point, the value at each visit was calculated as the average of values obtained for the same time point across profiles performed in the week before the visit.
Time Frame
Baseline, Week 16, Week 24
Title
Average Daily Insulin Doses
Description
Average daily insulin doses included basal insulin doses, mealtime insulin doses, and total insulin doses.
Time Frame
During 24 weeks treatment period
Title
Overall Study Experience-Sites (OSES) Questionnaire Part-1: Hours Spent by Investigator
Description
An OSES questionnaire was completed by Site Investigator and had 2 parts. The OSES Part-1 contained quantitative 1 item (question) to examine resource requirements which was: Approximately how much time did you spend with this participant (in person or via phone) during this scheduled visit/communication? (hours)
Time Frame
During 24 weeks treatment period
Title
Overall Study Experience-Sites Questionnaire Part-2 Scores for Site-Perceived Participant Relationship and Satisfaction at Week 24
Description
An OSES questionnaire was completed by site investigator and had two parts. OSES Part-2 contains 2 items to examine investigator-participant relationship and satisfaction with care. Both items were assessed on a scale of 0 [completely disagree] to 10 [completely agree]), where highest score indicated a good relationship and satisfaction with care.
Time Frame
At Week 24
Title
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
Description
Severe hypoglycemia was an event in which the participant required the assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions. Documented symptomatic hypoglycemia: an event during which typical symptoms of hypoglycemia were accompanied by a measured plasma glucose concentration of <=3.9 mmol/L (70 mg/dL) or <3.0 mmol/L (54 mg/dL). Asymptomatic hypoglycemia: an event not accompanied by typical symptoms of hypoglycemia but with a measured plasma glucose concentration <=3.9 mmol/L (70 mg/dL) or <3.0 mmol/L (54 mg/dL). Probable symptomatic hypoglycemia: an event during which symptoms of hypoglycemia were not accompanied by plasma glucose determination but was presumably caused by a plasma glucose concentration. Pseudo-hypoglycemia: an event with any of the typical symptoms of hypoglycaemia with plasma glucose concentration >3.9 mmol/L (70 mg/dL).
Time Frame
During 24 weeks treatment period
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Sciences & Operations
Organizational Affiliation
Sanofi
Official's Role
Study Director
Facility Information:
Facility Name
Investigational Site Number 8400002
City
West Des Moines
State/Province
Iowa
ZIP/Postal Code
50265
Country
United States
Facility Name
Investigational Site Number 8400004
City
Houston
State/Province
Texas
ZIP/Postal Code
77043
Country
United States
Facility Name
Investigational Site Number 8400003
City
Bridgeport
State/Province
West Virginia
ZIP/Postal Code
26330
Country
United States
Facility Name
Investigational Site Number 1240001
City
Barrie
ZIP/Postal Code
L4M 7G1
Country
Canada
Facility Name
Investigational Site Number 1240003
City
Oakville
ZIP/Postal Code
L6M 1M1
Country
Canada
Facility Name
Investigational Site Number 1240002
City
Thornhill
ZIP/Postal Code
L4J 8L7
Country
Canada
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org
Learn more about this trial
Evaluation of Virtual Versus Traditional Study Conducted in a Group Pilot Study in Adult Patients With Type 1 Diabetes Mellitus (eStudy)
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