Diabetes Mellitus, Type 2 Clinical Trial
Official title:
Fit-One: A Randomized Waitlist Controlled Trial Evaluating the Effect of One Drop and Fitbit on Diabetes and Pre-diabetes Outcomes
The Fit-One trial involves three prospective, randomized waitlist-controlled studies. These studies evaluate the effects of One Drop's digital therapeutics solution with and without Fitbit devices on the social cognitive, behavioral, and health outcomes of people with diabetes. Fit-One is being tested on adults with type 1 diabetes (T1D) of all weights, and adults with type 2 diabetes (T2D) or pre-diabetes that are overweight or obese (BMI ≥ 25).
Sub-study 1 (T2D). Eligible participants (N=300) with T2D, an A1c above 7.0% and Body Mass
Index (BMI) ≥ 25 will be randomized to one of three groups. Participants assigned to group 1
(n=100) get One Drop's digital therapeutics solution (app, meter, and 'On Track' in-app
coaching) and a Fitbit Ionic smartwatch and are asked to use both for 3 months. Participants
assigned to group 2 (n=100) get One Drop's digital therapeutics solution and are asked to use
it for 3 months. After 3 months, group 2 gets a Fitbit Ionic smartwatch. Finally,
participants assigned to group 3 (n=100) are asked to manage their diabetes without an app,
coach, or activity tracker for 3 months. After 3 months, group 3 gets One Drop's digital
therapeutics solution (app, meter, and 'On Track' in-app coaching) and a Fitbit Ionic
smartwatch (n=100).
Sub-study 2 (T1D). Eligible participants (N=100) with T1D and an A1c above 7.0% will be
randomized to one of two groups. Participants assigned to group 1 (n=50) get One Drop's
digital therapeutics solution (app, meter, and 'On Call' in-app coaching) and a Fitbit Ionic
smartwatch and are asked to use both for 3 months. Participants assigned to group 2 (n=50)
get One Drop's digital therapeutics solution and are asked to use it for 3 months. After 3
months, group 2 gets a Fitbit Ionic smartwatch.
Sub-study 3 (Pre-diabetes). Eligible participants (N=100) with pre-diabetes, an A1c between
5.7-6.4% and a BMI ≥ 25 will be randomized to one of two groups. Participants assigned to
group 1 (n=50) get One Drop's digital therapeutics solution ('Revive' in-app coaching) and a
Fitbit Charge 2 and are asked to use both for 3 months. Participants assigned to group 2
(n=50) get One Drop's digital therapeutics solution and are asked to use it for 3 months.
After 3 months, group 2 gets a Fitbit Charge 2.
;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Active, not recruiting |
NCT05666479 -
CGM Monitoring in T2DM Patients Undergoing Orthopaedic Replacement Surgery
|
||
| Completed |
NCT05647083 -
The Effect of Massage on Diabetic Parameters
|
N/A | |
| Active, not recruiting |
NCT05661799 -
Persistence of Physical Activity in People With Type 2 Diabetes Over Time.
|
N/A | |
| Completed |
NCT03686722 -
Effect of Co-administration of Metformin and Daclatasvir on the Pharmacokinetis and Pharmacodynamics of Metformin
|
Phase 1 | |
| Completed |
NCT02836704 -
Comparison of Standard vs Higher Starting Dose of Insulin Glargine in Chinese Patients With Type 2 Diabetes (Glargine Starting Dose)
|
Phase 4 | |
| Completed |
NCT01819129 -
Efficacy and Safety of FIAsp Compared to Insulin Aspart in Combination With Insulin Glargine and Metformin in Adults With Type 2 Diabetes
|
Phase 3 | |
| Completed |
NCT04562714 -
Impact of Flash Glucose Monitoring in People With Type 2 Diabetes Using Non-Insulin Antihyperglycemic Therapy
|
N/A | |
| Completed |
NCT02009488 -
Treatment Differences Between Canagliflozin and Placebo in Insulin Secretion in Subjects With Type 2 Diabetes Mellitus (T2DM)
|
Phase 1 | |
| Completed |
NCT05896319 -
Hyaluronic Acid Treatment of the Post-extraction Tooth Socket Healing in Subjects With Diabetes Mellitus Type 2
|
N/A | |
| Recruiting |
NCT05598203 -
Effect of Nutrition Education Groups in the Treatment of Patients With Type 2 Diabetes
|
N/A | |
| Completed |
NCT05046873 -
A Research Study Looking Into Blood Levels of Semaglutide and NNC0480-0389 When Given in the Same Injection or in Two Separate Injections in Healthy People
|
Phase 1 | |
| Terminated |
NCT04090242 -
Impact of App Based Diabetes Training Program in Conjunction With the BD Nano Pen Needle in People With T2 Diabetes
|
N/A | |
| Completed |
NCT04030091 -
Pulsatile Insulin Infusion Therapy in Patients With Type 1 and Type 2 Diabetes Mellitus
|
Phase 4 | |
| Completed |
NCT03604224 -
A Study to Observe Clinical Effectiveness of Canagliflozin 300 mg Containing Treatment Regimens in Indian Type 2 Diabetes Participants With BMI>25 kg/m^2, in Real World Clinical Setting
|
||
| Completed |
NCT03620357 -
Continuous Glucose Monitoring & Management In Type 2 Diabetes (T2D)
|
N/A | |
| Completed |
NCT01696266 -
An International Survey on Hypoglycaemia Among Insulin-treated Patients With Diabetes
|
||
| Completed |
NCT03620890 -
Detemir Versus NPH for Type 2 Diabetes Mellitus in Pregnancy
|
Phase 4 | |
| Withdrawn |
NCT05473286 -
A Research Study Looking at How Oral Semaglutide Works in People With Type 2 Diabetes in Germany, as Part of Local Clinical Practice
|
||
| Not yet recruiting |
NCT05029804 -
Effect of Walking Exercise Training on Adherence to Disease Management and Metabolic Control in Diabetes
|
N/A | |
| Completed |
NCT04531631 -
Effects of Dorzagliatin on 1st Phase Insulin and Beta-cell Glucose Sensitivity in T2D and Monogenic Diabetes
|
Phase 2 |