Evaluation of Virtual Versus Traditional Study Conducted... | NCT03260868

ID	Type	Description	Link
U1111-1188-5647	Other Identifier	UTN

Status Module

Description Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Virtual	Experimental	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.	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	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.	Drug: Insulin glargine, 300 units per milliliter (U/mL) Drug: Background therapy: Rapid Acting meal time insulin analogs (Humalog, Novolog or Apidra)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Insulin glargine, 300 units per milliliter (U/mL)	Drug	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).

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change From Baseline in Glycated Hemoglobin A1c (HbA1c) to Week 24	Change in HbA1c was calculated by subtracting baseline value from Week 24 value.	Baseline, Week 24

Secondary Outcomes

Measure	Description	Time Frame
Change From Baseline in Glycated Hemoglobin A1c to Week 16	Change in HbA1c was calculated by subtracting baseline value from Week 16 value.	Baseline, Week 16
Change From Baseline in Fasting Plasma Glucose (FPG) to Week 16 and Week 24

Eligibility Module

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.

Name	Affiliation	Role
Clinical Sciences & Operations	Sanofi	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Investigational Site Number 8400002		West Des Moines	Iowa	50265	United States
Investigational Site Number 8400004

IPD Sharing Statement Module

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Virtual	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.
FG001

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Mar 13, 2017	Nov 21, 2019

Arm/Group Information

ID	Title	Description
BG000	Virtual	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.
BG001	Traditional	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.
BG002	Total	Total of all reporting groups

Units	Counts
Participants	BG0008 BG0017 BG00215

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Continuous

Mean

Standard Deviation

years

Title

Denominators

Categories

Title	Measurements
	OG0000.10± 0.76 OG0010.33± 0.57

Secondary

Change From Baseline in Glycated Hemoglobin A1c to Week 16

Change in HbA1c was calculated by subtracting baseline value from Week 16 value.

Analysis was performed on ITT population. Here, 'overall number of participants analyzed' signifies participants with available data for the outcome measure.

Posted

Mean

Standard Deviation

percentage of HbA1c

Baseline, Week 16

ID	Title	Description
OG000	Virtual	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.
OG001	Traditional	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.

Units	Counts
Participants

Secondary

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.

Analysis was performed on ITT population. Here, "number analyzed" signifies participants with available data for each time point.

Posted

Mean

Standard Deviation

millimole per liter (mmol/L)

Baseline, Week 16, Week 24

ID	Title	Description
OG000	Virtual	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.
OG001	Traditional	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.

Units	Counts
Participants

Secondary

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.

Data were not collected due to data transfer issues therefore analysis was not performed for this outcome.

Posted

At Week 24

ID	Title	Description
OG000	Virtual	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.
OG001	Traditional	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.

Units	Counts

Secondary

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.

Data were not collected due to data transfer issues therefore analysis was not performed for this outcome.

Posted

Baseline, Week 24

ID	Title	Description
OG000	Virtual	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.
OG001	Traditional	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.

Units	Counts
Participants

Secondary

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.

Data were not collected due to data transfer issues therefore analysis was not performed for this outcome.

Posted

Baseline, Week 24

ID	Title	Description
OG000	Virtual	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.
OG001	Traditional	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.

Units	Counts

Secondary

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.

Data were not collected due to data transfer issues therefore analysis was not performed for this outcome.

Posted

Baseline, Week 24

ID	Title	Description
OG000	Virtual	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.
OG001	Traditional	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.

Units	Counts

Secondary

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.

Data were not collected due to data transfer issues therefore analysis was not performed for this outcome.

Posted

During 24 weeks treatment period

ID	Title	Description
OG000	Virtual	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.
OG001	Traditional	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.

Units	Counts
Participants

Secondary

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).

Data were not collected due to data transfer issues therefore analysis was not performed for this outcome.

Posted

Baseline, Week 24

ID	Title	Description
OG000	Virtual	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.
OG001	Traditional	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.

Units	Counts

Secondary

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.

Data were not collected due to data transfer issues therefore analysis was not performed for this outcome.

Posted

Baseline, Week 24

ID	Title	Description
OG000	Virtual	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.
OG001	Traditional	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.

Units	Counts

Secondary

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.

Data were not collected due to data transfer issues therefore analysis was not performed for this outcome.

Posted

At Week 24

ID	Title	Description
OG000	Virtual	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.
OG001	Traditional	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.

Secondary

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.

Data were not collected due to data transfer issues therefore analysis was not performed for this outcome.

Posted

Week 0, Week 24

ID	Title	Description
OG000	Virtual	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.
OG001	Traditional	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.

Units	Counts

Secondary

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.

Data were not collected due to data transfer issues therefore analysis was not performed for this outcome.

Posted

Baseline, Week 16, Week 24

ID	Title	Description
OG000	Virtual	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.
OG001	Traditional	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.

Units

Secondary

Average Daily Insulin Doses

Average daily insulin doses included basal insulin doses, mealtime insulin doses, and total insulin doses.

Data were not collected due to data transfer issues therefore analysis was not performed for this outcome.

Posted

During 24 weeks treatment period

ID	Title	Description
OG000	Virtual	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.
OG001	Traditional	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.

Units	Counts
Participants	OG000

Secondary

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)

Data were not collected due to data transfer issues therefore analysis was not performed for this outcome.

Posted

During 24 weeks treatment period

ID	Title	Description
OG000	Virtual	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.
OG001	Traditional	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.

Units	Counts
Participants

Secondary

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.

Data were not collected due to data transfer issues therefore analysis was not performed for this outcome.

Posted

At Week 24

ID	Title	Description
OG000	Virtual	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.
OG001	Traditional	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.

Units	Counts

Secondary

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).

Analysis was done on safety population which included all randomized participants who did actually receive at least one dose of investigational medicinal product (IMP), regardless of the amount of IMP administered.

Posted

Count of Participants

Participants

During 24 weeks treatment period

ID	Title	Description
OG000	Virtual	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/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Virtual	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.	0	8	1	8	2	8
EG001	Traditional	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.	0	6	1	6	4	6

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Obstructive Pancreatitis	Gastrointestinal disorders	MedDRA 21.1	Systematic Assessment	EG0001 events1 affected8 at risk EG0010 events0 affected6 at risk
Cholecystitis Acute	Hepatobiliary disorders	MedDRA 21.1	Systematic Assessment	EG0001 events1 affected8 at risk EG0010 events0 affected6 at risk
Escherichia Bacteraemia	Infections and infestations	MedDRA 21.1	Systematic Assessment	EG0001 events1 affected8 at risk EG0010 events0 affected6 at risk
Loss Of Consciousness	Nervous system disorders	MedDRA 21.1	Systematic Assessment	EG0000 events0 affected8 at risk EG0011 events1 affected6 at risk
Acute Respiratory Failure	Respiratory, thoracic and mediastinal disorders	MedDRA 21.1	Systematic Assessment	EG0001 events1 affected8 at risk EG0010 events0 affected6 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Diarrhoea	Gastrointestinal disorders	MedDRA 21.1	Systematic Assessment	EG0000 events0 affected8 at risk EG0011 events1 affected6 at risk
Oedema Peripheral	General disorders	MedDRA 21.1	Systematic Assessment	EG0000 events0 affected8 at risk EG0011 events1 affected6 at risk
Cholelithiasis	Hepatobiliary disorders	MedDRA 21.1	Systematic Assessment	EG0001 events1 affected8 at risk EG0010 events0 affected6 at risk
Gastroenteritis Viral	Infections and infestations	MedDRA 21.1	Systematic Assessment	EG0000 events0 affected8 at risk EG0011 events1 affected6 at risk
Nasopharyngitis	Infections and infestations	MedDRA 21.1	Systematic Assessment	EG0000 events0 affected8 at risk EG0012 events2 affected6 at risk
Upper Respiratory Tract Infection	Infections and infestations	MedDRA 21.1	Systematic Assessment	EG0001 events1 affected8 at risk EG0011 events1 affected6 at risk
Alcohol Poisoning	Injury, poisoning and procedural complications	MedDRA 21.1	Systematic Assessment	EG0000 events0 affected8 at risk EG0011 events1 affected6 at risk
Head Injury	Injury, poisoning and procedural complications	MedDRA 21.1	Systematic Assessment	EG0000 events0 affected8 at risk EG0011 events1 affected6 at risk
Blood Pressure Increased	Investigations	MedDRA 21.1	Systematic Assessment	EG0001 events1 affected8 at risk EG0010 events0 affected6 at risk
Intervertebral Disc Degeneration	Musculoskeletal and connective tissue disorders	MedDRA 21.1	Systematic Assessment	EG0000 events0 affected8 at risk EG0011 events1 affected6 at risk
Vertebral Osteophyte	Musculoskeletal and connective tissue disorders	MedDRA 21.1	Systematic Assessment	EG0000 events0 affected8 at risk EG0011 events1 affected6 at risk
Intermittent Claudication	Vascular disorders	MedDRA 21.1	Systematic Assessment	EG0001 events1 affected8 at risk EG0010 events0 affected6 at risk

ID	Term
D003920	Diabetes Mellitus
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases
D004700	Endocrine System Diseases
D001327	Autoimmune Diseases
D007154	Immune System Diseases

ID	Term
D000069036	Insulin Glargine
D061268	Insulin Lispro
D061267	Insulin Aspart
C479079	insulin glulisine

ID	Term
D049528	Insulin, Long-Acting
D061385	Insulins
D010187	Pancreatic Hormones
D036361	Peptide Hormones
D006728	Hormones
D006730	Hormones, Hormone Substitutes, and Hormone Antagonists
D010455	Peptides
D000602	Amino Acids, Peptides, and Proteins
D061266	Insulin, Short-Acting