Evaluation of Virtual Versus Traditional Study Conducted in a Group Pilot Study in Adult Patients With Type 1 Diabetes Mellitus (eStudy)

What Was Tested

The trial (phase 4) is built around Insulin Glargine and Insulin Aspart.

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.

It had two arms (groups): Virtual (experimental) and Traditional (active comparator).

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.

The registry classes the interventions as drug.

Who Took Part

15 actual participants took part.

It was open to people of any sex aged from 18 years with no upper age limit.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Participants with Type 1 diabetes mellitus (T1DM) diagnosed at least one year before the screening visit. Participants with access to or experience with mobile technology (eg, tablet or smart phone). ESign the consent on the study web portal.

The full record lists 4 inclusion and 12 exclusion criteria; among the exclusions: age less than (\<) 18 years at screening (visit 1 - step 1); type 2 diabetes mellitus; participants who received \<6 months treatment with any basal plus (+) meal-time insulin.

How the Study Was Run

Design: randomized, parallel-group and open-label.

The participants were allocated by chance, so the Insulin Glargine group and the comparison group should start out alike.

The Insulin Glargine group and the comparison group ran side by side rather than switching.

Nothing was hidden in this open-label Insulin Glargine study: the participants and staff both knew the treatment.

It started in 2017-09-19 with completion listed for 2018-11-22.

It ran at 6 sites in United States (3) and Canada (3).

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Change From Baseline in Glycated Hemoglobin A1c (HbA1c) to Week 24 (time frame: Baseline, Week 24).

It also tracked 16 secondary outcomes, for example Change From Baseline in Glycated Hemoglobin A1c to Week 16, Change From Baseline in Fasting Plasma Glucose (FPG) to Week 16 and Week 24, Participant Satisfaction With Trial Experience: Was It Worth It (WIWI) Questionnaire Response at Week 24, Change From Baseline in Work Productivity and Impairment-Study Participation (WPAI-SP) Scores to Week 24, Change From Baseline in Overall Study Experience-Participation (OSEP) Part-1 Questionnaire Score to Week 24 and Change From Baseline in Overall Study Experience-Participation Part-2 Questionnaire Score to Week 24.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Insulin Glargine and Insulin Aspart in 15 people.

Its size is small, so on its own it can only give an early look.

It ended early (terminated); results are posted on the registry, and this page does not restate them.

More context: the Insulin Glargine compound page and the Insulin Aspart compound page, all human trials.