Type 2 Diabetes MellitusPOMANCT06148376
Application of a Protocol of Personalized Medicine in Patients With Type 2 Diabetes Mellitus and Multiple Doses of Insulin in Routine Clinical Care
An observational study of Type 2 Diabetes Mellitus and Multiple Dose Insulin Therapy, run by Hospital Arnau de Vilanova at 2 sites in Spain.
Trial summary
The goal of this observational study is to test a protocol of personalized medicine in routine clinical practice in people with type 2 diabetes (T2DM) treated with multiple dose insulin injections (MDI). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Type 2 Diabetes Mellitus, Multiple Dose Insulin Therapy
- What is being tested?
- Personalized treatment
- How many people
- 239 participants
- Where
- 2 sitesSpain
- Study dates
- 1 Dec 2023to 30 Sep 2025
- How long will I take part?
- 6 Months
- 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: All the patients in our territory treated with multiple dose insulin therapy without exclusion criteria are elegible to participate.
Who may be able to join
- Type 2 diabetes treated with multiple dose insulin therapy
Who cannot join
- Gestation or planning gestation in the following 12 months
- Glucocorticoid use for an acute condition
- Transient insulinisationt (less than 6 months)
- Any condition that prevents the patient or their caregiver from following up for 6 months
- Severe mental illness
- Drug or alcohol abuse
Trial locations and contacts
2 sites in 1 country.
Spain2 sites
Hospital Universitari Arnau de Vilanova
Lleida, 25198
Centres Atenció Primària Lleida, Alt Pirineu i Aran
Lleida
About this study
The goal of this observational study is to test a protocol of personalized medicine in routine clinical practice in people with type 2 diabetes (T2DM) treated with multiple dose insulin injections (MDI).
The main question[s] it aims to answer are:
Read more
- Are c-peptide titers and B-cell autoimmunity useful to help the decision of suspending prandial insulin in patients with T2DM treated with MDI?
Participants will:
- Wear a continuous glucose monitor for 10-14 days
- Will be asked for a C-peptide and GAD antibody test (GADA)
- Will stop prandial insulin and switch to other diabetes treatments if needed if c-peptide is > 0.7 mmol/L and/or C-peptide is > 0.3 mmol/L and GADA are negative
- Will be followed-up by their GP in routine clinical practice
- Will be assessed after 6 months (CGM, HbA1c, quality of life (QoL)
Read the detailed description
An algorithm will be applied in which, depending on the presence/absence of pancreatic autoimmunity and the estimation of pancreatic reserve, the same treatment will be maintained and CGM (continuous glucose monitoring) will be initiated or the prandial insulin and the treatment will be adjusted following the main clinical guidelines.
- Being tested
- Personalized treatment
- Keywords
- Type 2 Diabetes Meliitus, Multiple dose insulin therapy, personalized medicine
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Personalized treatmentOther
Discontinue prandial insulin treatment
| Study group | Role | What they receive |
|---|---|---|
| MDI T2DM | Patients wit type 2 diabetes (T2DM) treated with multiple dose insulin therapy (MDI) Receives: Other: Personalized treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of patients whose prandial insulin is withdrawn
Percentage of patients whose prandial insulin is withdrawn
Measured: At 6 months from the inclusion
Secondary outcomes (5)
Glucose control
HbA1c, continuous glucose monitoring data
Measured: 6 months
Number of severe hypoglycaemia events
Severe hypoglycemia defined in Seaquist ER, Anderson J, Childs B, et al. Hypoglycemia and diabetes: a report of a workgroup of the American Diabetes Association and the Endocrine Society. Diabetes Care. 2013;36(5):1384-1395.
Measured: 6 months
Diabetes quality of life
ESDQoL
Measured: 6 months
Adherence to trearment
ARMS-E questionnaire
Measured: 6 months
Diabetes treatment satisfaction
DTSQs, DTSQc questionnaire
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Nov 2023
- Study start1 Dec 2023
- Primary completion30 Sep 2025
- Study completion30 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Prospective
- Enrolment
- 239 participants (actual)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Hospital Arnau de Vilanova
- Sponsor type
- University, hospital or other
- Collaborators
- Institut Catala de Salut
- Responsible party
- Principal investigator, Marta Hernandez Garcia, Hospital Arnau de Vilanova
- Investigators
- Marta Hernández, MD PhD, Principal investigator, Hospital Arnau de Vilanova
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06148376
- Sponsor's protocol ID
- 2965LO
- Acronym
- POMA
- Status last verified
- Mar 2026
- First submitted
- 18 Nov 2023
- Last updated
- 11 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Gine-Balcells R, Vlacho B, Vidal-Perez OC, Lecube A, Franch-Nadal J, Mauricio D, Mollo-Iniesta A, Hernandez M; POMA Study Group. Implementation of a Personalized Medicine Approach in Patients With Type 2 Diabetes Mellitus Receiving Multiple Daily Insulin Injections (POMA Project): Protocol for a Before-and-After Intervention Study. JMIR Res Protoc. 2026 Feb 24;15:e85375. doi: 10.2196/85375.
PubMed 41734338
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Application of a Protocol of Personalized Medicine in Patients With Type 2 Diabetes Mellitus and Multiple Doses of Insulin in Routine Clinical Care
- ClinicalTrials.gov ID
- NCT06148376
- Acronym / sponsor ID
- POMA / 2965LO
- Keywords
- Type 2 Diabetes Meliitus, Multiple dose insulin therapy, personalized medicine
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 239 participants (actual)
- Lead sponsor
- Hospital Arnau de VilanovaUniversity, hospital or other
- Collaborators
- Institut Catala de Salut
- Study start
- 1 Dec 2023 (actual)
- Primary completion
- 30 Sep 2025 (actual)
- Study completion
- 30 Sep 2025 (actual)
- First posted
- 28 Nov 2023 (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 goal of this observational study is to test a protocol of personalized medicine in routine clinical practice in people with type 2 diabetes (T2DM) treated with multiple dose insulin injections (MDI).
The main question[s] it aims to answer are:
- Are c-peptide titers and B-cell autoimmunity useful to help the decision of suspending prandial insulin in patients with T2DM treated with MDI?
Participants will:
- Wear a continuous glucose monitor for 10-14 days
- Will be asked for a C-peptide and GAD antibody test (GADA)
- Will stop prandial insulin and switch to other diabetes treatments if needed if c-peptide is > 0.7 mmol/L and/or C-peptide is > 0.3 mmol/L and GADA are negative
- Will be followed-up by their GP in routine clinical practice
- Will be assessed after 6 months (CGM, HbA1c, quality of life (QoL)
Detailed description
An algorithm will be applied in which, depending on the presence/absence of pancreatic autoimmunity and the estimation of pancreatic reserve, the same treatment will be maintained and CGM (continuous glucose monitoring) will be initiated or the prandial insulin and the treatment will be adjusted following the main clinical guidelines.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 6 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MDI T2DM | – | Other: Personalized treatmentPatients wit type 2 diabetes (T2DM) treated with multiple dose insulin therapy (MDI) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All the patients in our territory treated with multiple dose insulin therapy without exclusion criteria are elegible to participate.
Key inclusion criteria (1 listed)
- Type 2 diabetes treated with multiple dose insulin therapy
Key exclusion criteria (6 listed)
- Gestation or planning gestation in the following 12 months
- Glucocorticoid use for an acute condition
- Transient insulinisationt (less than 6 months)
- Any condition that prevents the patient or their caregiver from following up for 6 months
- Severe mental illness
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Personalized treatmentDiscontinue prandial insulin treatment | Other | MDI T2DM |
Primary outcome
Percentage of patients whose prandial insulin is withdrawn
Time frame: At 6 months from the inclusion
Percentage of patients whose prandial insulin is withdrawn
5 secondary outcomes
Glucose control
Time frame: 6 months
Number of severe hypoglycaemia events
Time frame: 6 months
Diabetes quality of life
Time frame: 6 months
Adherence to trearment
Time frame: 6 months
Diabetes treatment satisfaction
Time frame: 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 11 Mar 2026.
- Derived from this study: PubMed 41734338Gine-Balcells R, Vlacho B, Vidal-Perez OC, Lecube A, Franch-Nadal J, Mauricio D, Mollo-Iniesta A, Hernandez M; POMA Study Group. Implementation of a Personalized Medicine Approach in Patients With Type 2 Diabetes Mellitus Receiving Multiple Daily Insulin Injections (POMA Project): Protocol for a Before-and-After Intervention Study. JMIR Res Protoc. 2026 Feb 24;15:e85375. doi: 10.2196/85375.
- Individual participant dataSharing planned: No
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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.
Marta Hernández, MD PhD principal investigator
Hospital Arnau de Vilanova
2 sites 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 and Multiple Dose Insulin Therapy, run by Hospital Arnau de Vilanova at 2 sites in Spain.
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 1 inclusion and 6 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 11 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Spain. 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?
Percentage of patients whose prandial insulin is withdrawn (time frame: At 6 months from the inclusion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06148376, which also lists 1 linked publication.
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 11 Mar 2026.