Type 2 Diabetes MellitusINSULIANCT05331339
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)
An observational study of Type 2 Diabetes Mellitus, run by Centre Hospitalier Sud Francilien at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Type 2 Diabetes Mellitus
- How many people
- 68 participants
- Where
- 1 siteFrance
- Study dates
- 2 Nov 2022to 2 Dec 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Single-center diabetes department of a French public hospital.
Who may be able to join
- 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
Who cannot join
- Patient opposed to the research
Trial locations and contacts
1 site in 1 country.
About this study
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)
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.
Read the detailed 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.
- Conditions
- Type 2 Diabetes Mellitus
- Medical subject headings
- Diabetes Mellitus, Type 2
What is being measured
The primary outcome is the main question the study is designed to answer.
HbA1c
Evolution of HbA1c between baseline and 6 months after Insulia initiation
Measured: at 6 months
Secondary outcomes (3)
Insulin
Evolution of daily dose of basal insulin between baseline and 6 months after Insulia initiation
Measured: at 6 months
HbA1c objective
Percentage of patients reaching the HbA1c target after 6 months
Measured: at 6 months
Mean fasting glucose
Percentage of patients reaching a mean fasting glucose < 150 mg/dL for 7 days after 6 months
Measured: at 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2022
- Study start2 Nov 2022
- Primary completion2 Dec 2022
- Study completion2 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 Diabetes MellitusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Sud Francilien
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05331339
- Sponsor's protocol ID
- 2022/0004
- Acronym
- INSULIA
- Status last verified
- Nov 2024
- First submitted
- 8 Apr 2022
- Last updated
- 26 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT05331339
- Acronym / sponsor ID
- INSULIA / 2022/0004
- Conditions
- Type 2 Diabetes Mellitus
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- Centre Hospitalier Sud FrancilienUniversity, hospital or other
- Study start
- 2 Nov 2022 (actual)
- Primary completion
- 2 Dec 2022 (actual)
- Study completion
- 2 Dec 2022 (actual)
- First posted
- 15 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Single-center diabetes department of a French public hospital.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (1 listed)
- Patient opposed to the research
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
HbA1c
Time frame: at 6 months
Evolution of HbA1c between baseline and 6 months after Insulia initiation
3 secondary outcomes
Insulin
Time frame: at 6 months
HbA1c objective
Time frame: at 6 months
Mean fasting glucose
Time frame: at 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Nov 2024.
Related trials for Type 2 Diabetes Mellitus
Not yet recruitingPhase 3
Efficacy and Safety of Once-Weekly SHR-3167 Compared With Once-Daily Insulin Glargine in Adults With Insulin-Naive Type 2 Diabetes
Type 2 Diabetes
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Not yet recruitingPhase 3
A Study to Evaluate the Effectiveness and Safety of the Drug AZD6234 for Managing Weight in Adults Who Are Obese or Overweight. These Participants May or May Not Also Have Type 2 Diabetes
Obesity, Overweight
Not yet recruiting
Impact of Endoscopic Sleeve Gastroplasty (ESG) in Obese Adults With Type 2 Diabetes (T2D)
Type 2 Diabetes Mellitus (T2D), Obesity (BMI>30)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Type 2 Diabetes Mellitus, run by Centre Hospitalier Sud Francilien at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HbA1c (time frame: at 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Nov 2024.