Clinical Trials Logo
  1. Home
  2. Type 2 Diabetes Mellitus
  3. NCT05331339
  4. Details
NCT05331339 Clinical Trial

Real-life Efficacy of Insulia® Tool in Patients Living With Type 2 Diabetes Treated With Basal Insulin Therapy as Part of a National Telemedicine Program (ETAPES)

Type 2 Diabetes Mellitus Clinical Trial

— INSULIA  

Official title:
Effectiveness in Real Life of the Insulia® Digital Tool in Patients With Type 2 Diabetes Treated With Basal Insulin Therapy as Part of a National Telemedicine Program (ETAPES)

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT05331339
Other study ID # 2022/0004
Secondary ID
Status Completed
Phase
First received
Last updated
Start date November 2, 2022
Est. completion date December 2, 2022

Study information
Verified date February 2023
Source Centre Hospitalier Sud Francilien
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The purpose of this study was to evaluate the INSULIA digital tool (automation of basal insulin dose calculation in type 2 diabetes) within the framework of a French national telemedicine experimentation program (ETAPES) in a single-center study. The assumption is that a better metabolic control with this tool.

Description:

Basal insulin titration in people with type 2 diabetes is of major importance to obtain the optimal dose to regulate fasting blood glucose without hypoglycemia. Significant inertia in treatment optimization has been observed among both general practitioners and diabetologists. The INSULIA tool (automation of basal insulin dose calculation in type 2 diabetes) within the framework of a French national telemedicine experimentation program (ETAPES) has been supported by the health authorities. The data collected are of a single-center cohort of adult patients with type 2 diabetes who used this tool between 2018 and 2021. It is supposed that a better metabolic control with this tool and aimed to understand factors associated with better results.

Recruitment information / eligibility
Status Completed
Enrollment 68
Est. completion date December 2, 2022
Est. primary completion date December 2, 2022
Accepts healthy volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Age = 18 years old. - Patients with type 2 diabetes. - Initiation or adjustment of basal insulin. - Prescription of Insulia® for more than 6 months (between august 2018 and june 2021) - Informed patient not opposed to the research Exclusion Criteria: Patient opposed to the research

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
France Centre Hospitalier Sud Francilien Corbeil-essonnes Cedex

Sponsors (1)
Lead Sponsor Collaborator
Centre Hospitalier Sud Francilien

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary HbA1c Evolution of HbA1c between baseline and 6 months after Insulia initiation at 6 months
Secondary Insulin Evolution of daily dose of basal insulin between baseline and 6 months after Insulia initiation at 6 months
Secondary HbA1c objective Percentage of patients reaching the HbA1c target after 6 months at 6 months
Secondary Mean fasting glucose Percentage of patients reaching a mean fasting glucose < 150 mg/dL for 7 days after 6 months at 6 months
See also
  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 NCT02252224 - Forxiga (Dapagliflozin) Regulatory Postmarketing Surveillance