Evaluation of Virtual Versus Traditional Study Conducted in a Group Pilot Study in Adult Patients With Type 1 Diabetes Mellitus (eStudy)
- Conditions
- Type 1 Diabetes Mellitus
- Interventions
- Drug: Insulin glargine, 300 units per milliliter (U/mL)
- Registration Number
- NCT03260868
- Lead Sponsor
- Sanofi
- 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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 15
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Traditional Insulin glargine, 300 units per milliliter (U/mL) 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. Virtual Insulin glargine, 300 units per milliliter (U/mL) 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.
- Primary Outcome Measures
Name Time Method Change From Baseline in Glycated Hemoglobin A1c (HbA1c) to Week 24 Baseline, Week 24 Change in HbA1c was calculated by subtracting baseline value from Week 24 value.
- Secondary Outcome Measures
Name Time Method Change From Baseline in Glycated Hemoglobin A1c to Week 16 Baseline, Week 16 Change in HbA1c was calculated by subtracting baseline value from Week 16 value.
Participant Satisfaction With Trial Experience: Was It Worth It (WIWI) Questionnaire Response at Week 24 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 Fasting Plasma Glucose (FPG) to Week 16 and Week 24 Baseline, Week 16, 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.
Resource Use Questionnaire (RUQ) Scores During 24 weeks treatment period 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 Work Productivity and Impairment-Study Participation (WPAI-SP) Scores to Week 24 Baseline, 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 Baseline, 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 Diabetes Treatment Satisfaction Questionnaire Change (DTSQc) Score to Week 24 Baseline, 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.
Average Daily Insulin Doses During 24 weeks treatment period 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 During 24 weeks treatment period 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)
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 During 24 weeks 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).
Hypoglycemia Fear Survey-II (HFS-II) Scores At Week 24 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.
Change From Baseline in Overall Study Experience-Participation Part-2 Questionnaire Score to Week 24 Baseline, 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.
Change From Baseline in Diabetes Treatment Satisfaction Questionnaire Status (DTSQs) to Week 24 Baseline, 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).
Diabetes Distress Scale (DDS) Scores Week 0, Week 24 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 Baseline, Week 16, Week 24 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.
Overall Study Experience-Sites Questionnaire Part-2 Scores for Site-Perceived Participant Relationship and Satisfaction at Week 24 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.
Trial Locations
- Locations (6)
Investigational Site Number 1240001
🇨🇦Barrie, Canada
Investigational Site Number 1240003
🇨🇦Oakville, Canada
Investigational Site Number 8400004
🇺🇸Houston, Texas, United States
Investigational Site Number 8400002
🇺🇸West Des Moines, Iowa, United States
Investigational Site Number 8400003
🇺🇸Bridgeport, West Virginia, United States
Investigational Site Number 1240002
🇨🇦Thornhill, Canada