Type 2 Diabetes Mellitus Clinical Trial
Official title:
Evaluation of the Impact of a Mobile Health App to Improve Self-control and Health Outcomes of Patients With Type 2 Diabetes Mellitus: Pilot Study "NOVAME"
The objective of this project is to evaluate the effectiveness and cost effectiveness of a health app (NOVAME) designed to improve the self-control of patients with T2DM and their health outcomes. The central focus of NOVAME is the continuous support to the patient and monitoring through the app that will act as a personalized and dynamic virtual coach that will help the patient to adopt healthy habits and change their behaviors through training plans in different areas: exercise physical, healthy eating, therapeutic education and emotional management The design of the evaluation is the randomized clinical trial, in the intervention arm patients will use the app NOVAME and in the control group, patients don't receive any additional educational or supporting activities beyond the usual activities provided by the Canary Islands Health Service (CIHS). The main outcome measure is the change in HbA1c at 3 months, requiring a total of 197 patients to detect a difference of at least 0.4% considering a 10% loss. As secondary measures HbA1c is collected at 12 months and other biochemical results (lipids and glucose), BMI and a series of questionnaires to measure changes in life habits (diet, physical activity), anxiety and depression, knowledge about their disease , degree of empowerment, satisfaction and usability of the app, .. Will be collected at 3 and 12 months. The differences between the arms will be measured with mixed generalized linear models. The cost effectiveness will be calculated by calculating life years adjusted for quality (QALY) and the cost of the disease, including the use of resources reported by patients. The benefits of the technology will be expressed in terms of HbA1c and QALY.
n/a
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT02771093 -
An Exploratory Study of the Effects of Trelagliptin and Alogliptin on Glucose Variability in Patients With Type 2 Diabetes Mellitus
|
Phase 4 | |
| Completed |
NCT02545842 -
Assessment Study of Three Different Fasting Plasma Glucose Targets in Chinese Patients With Type 2 Diabetes Mellitus (BEYOND III/FPG GOAL)
|
Phase 4 | |
| Recruiting |
NCT03436212 -
Real-Life Home Glucose Monitoring Over 14 Days in T2D Patients With Intensified Therapy Using Insulin Pump.
|
N/A | |
| Completed |
NCT03244800 -
A Study to Investigate Different Doses of 0382 in Overweight and Obese Subjects With Type 2 Diabetes Mellitus.
|
Phase 2 | |
| Completed |
NCT03960424 -
Diabetes Management Program for Hispanic/Latino
|
N/A | |
| Withdrawn |
NCT02769091 -
A Study in Adult Patients With Nonalcoholic Steatohepatitis Who Also Have Type 2 Diabetes
|
Phase 2 | |
| Recruiting |
NCT06065540 -
A Research Study to See How Well CagriSema Compared to Semaglutide, Cagrilintide and Placebo Lowers Blood Sugar and Body Weight in People With Type 2 Diabetes Treated With Metformin With or Without an SGLT2 Inhibitor
|
Phase 3 | |
| Recruiting |
NCT05008276 -
Puberty, Diabetes, and the Kidneys, When Eustress Becomes Distress (PANTHER Study)
|
||
| Completed |
NCT04091373 -
A Study Investigating the Pharmacokinetics of a Single Dose Administration of Cotadutide
|
Phase 1 | |
| Completed |
NCT03296800 -
Study to Evaluate Effects of Probenecid, Rifampin and Verapamil on Bexagliflozin in Healthy Subjects
|
Phase 1 | |
| Recruiting |
NCT06212778 -
Relationship Between Nutritional Status, Hand Grip Strength, and Fatigue in Hospitalized Older Adults With Type 2 Diabetes Mellitus.
|
||
| Completed |
NCT05979519 -
Fresh Carts for Mom's to Improve Food Security and Glucose Management
|
N/A | |
| Recruiting |
NCT05579314 -
XW014 in Healthy Subjects and Patients With Type 2 Diabetes Mellitus (T2DM)
|
Phase 1 | |
| Completed |
NCT03859934 -
Metabolic Effects of Melatonin Treatment
|
Phase 1 | |
| Terminated |
NCT03684642 -
Efficacy and Safety of Efpeglenatide Versus Dulaglutide in Patients With Type 2 Diabetes Mellitus Inadequately Controlled With Metformin
|
Phase 3 | |
| Completed |
NCT03248401 -
Effect of Cilostazol on Carotid Atherosclerosis Estimated by 3D Ultrasound in Patients With Type 2 Diabetes
|
Phase 4 | |
| Completed |
NCT03644134 -
A Personalized Intervention to Manage Physiological Stress and Improve Sleep Patterns
|
N/A | |
| Completed |
NCT05295160 -
Fasting-Associated Immune-metabolic Remission of Diabetes
|
N/A | |
| Completed |
NCT02836873 -
Safety and Efficacy of Bexagliflozin in Type 2 Diabetes Mellitus Patients With Moderate Renal Impairment
|
Phase 3 | |
| Completed |
NCT02226003 -
Efficacy and Safety of Ertugliflozin (MK-8835/PF-04971729) With Sitagliptin in the Treatment of Participants With Type 2 Diabetes Mellitus (T2DM) With Inadequate Glycemic Control on Diet and Exercise (MK-8835-017)
|
Phase 3 |