Diabetes Type 2MFG-SNONCT05443204
Evaluation of Glycemic Control by Flash Monitoring of Glucose (MFG) in Malnourished Patients With Type 2 Diabetes
A study testing Fortimel energy and Nutrision Advanced Diason Energy HP in people with Diabetes Type 2 and Malnutrition, run by Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud at 1 site in Spain.
Trial summary
Evaluation of Glycemic Control by Flash Monitoring of Glucose (MFG) in Malnourished Patients With Type 2 Diabetes (MFG SNO) Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Diabetes Type 2, Malnutrition
- What is being tested?
- Fortimel energy and Nutrision Advanced Diason Energy HP
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteSpain
- Study dates
- 7 Jul 2022to 31 May 2023
- Phase
- Interventional
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients with DM2 under follow-up by the Clinical Nutrition and Dietetics Unit (UNCYD) who present malnutrition or are at risk of malnutrition and require oral nutritional supplements, for a minimum estimated period of 3 months.
Who cannot join
- Patients with DM1, steroid diabetes, pancreatic diabetes, DM2 treated with rapid insulin, glomerular filtration rate less than 30 mL/min/1.73m2, intolerance to the product, gastrectomy or gastroparesis.
- Patients who do not sign the consent informed.
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Hospital Regional Universitario de Málaga
Málaga, 29010
Viyey Kishore Doulatram Gamgaram, MD, PhD, 951290343, viyu90@hotmail.es
Gabriel Olveira Fuster, MD,PhD, 951290343, gabrielm.olveira.sspa@juntadeandalucia.es
About this study
Official title: Evaluation of Glycemic Control by Flash Monitoring of Glucose (MFG) in Malnourished Patients With Type 2 Diabetes and Oral Supplements: Standard Formula vs Specific Formula for Diabetes
Evaluation of Glycemic Control by Flash Monitoring of Glucose (MFG) in Malnourished Patients With Type 2 Diabetes (MFG SNO)
Read the detailed description
In people with malnutrition and diabetes who require oral supplementation, there is no evidence clear when choosing a specific supplement for diabetes or a standard supplement. To date, there are no studies evaluating flash glucose monitoring in people with DM2 with supplements, nor studies comparing formulas specific for diabetes with standard formulas. Patients with type 2 diabetes, malnutrition and requiring oral nutritional supplements for 3 months will be included in the study.
A standard supplement (minimum 2 per day) will be prescribed for 2 weeks, an installation of the MFG system indicating that the scans are performed at start up, at the time and two hours after taking the oral supplement at home, as it doesn't happen anymore 8 hours without scanning to avoid losing information. After 14 days participants will go to consultation to download MFG data, assess acute response after taking of the supplement in the presence of health personnel (every 15 minutes for 4 hours). Investigators will change the sensor and nutritional supplement to a specific diabetes formula, after 14 days participants will come for MFG data download and to assess acute response after taking the supplement in the presence of healthcare personnel.
The results of the study will allow us to carry out a more appropriate treatment in this profile of patients, which is increasingly prevalent in our consultations.
- Conditions
- Diabetes Type 2, Malnutrition
- Being tested
- Fortimel energy, Nutrision Advanced Diason Energy HP
- Keywords
- Diabetes type 2, Malnutrition, MFG
- Medical subject headings
- Diabetes Mellitus, Type 2, Malnutrition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fortimel energyOther
Standard nutritional oral supplement
Nutrision Advanced Diason Energy HPOther
Specifc nutritional oral supplement in diabetics patients
| Study group | Role | What they receive |
|---|---|---|
| Standard Formula (Fortimel) | Experimental | Fats 35% total caloric volume (VCT) Carbohydrates: 49% del VCT Proteins: 16% del VCT Density: 1.5 kcal/ ml Receives: Other: Fortimel energy |
| Specific formula for diabetes (Nutrision Advanced) | Experimental | Fats: 46% del VCT (60% monounsaturated fatty acids) Carbohydrates: 31% del VCT Proteins: 21% del VFiber: 2% VCT (80% soluble y 20% insoluble) Density: 1.5kcal/ml Receives: Other: Nutrision Advanced Diason Energy HP |
What is being measured
The primary outcome is the main question the study is designed to answer.
MFG discharge - mean interstitial glucose
Interstitial glucose measured in mg/dl
Measured: During 14 days after taking the supplement
MFG discharge - hyperglycaemia
hyperglycaemia measured in mg/dl
Measured: During 14 days after taking the supplement
MFG discharge - hypoglycaemia
hypoglycaemia measured in mg/dl
Measured: During 14 days after taking the supplement
MFG discharge - GMI
Measured in number of scans per day
Measured: During 14 days after taking the supplement
MFG discharge - hypoglycaemic events
Measured in number and duration per day
Measured: During 14 days after taking the supplement
Secondary outcomes (1)
Postprandial glucose intersticial monitoringdiabetes specific supplement
Glucose intersticial measured in mg/dl
Measured: During the 4 hours after taking standard formula and the one specific for diabetes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2022
- Study start7 Jul 2022
- Primary completion31 Dec 2022 (estimated)
- Study completion31 May 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Type 2Studies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patients will be assigned in a 1:1 ratio
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gabriel Olveira Fuster, MD, PhD., Principal investigator, Hospital Regional Universitario de Málaga - FIMABIS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05443204
- Sponsor's protocol ID
- MFG SNO
- Acronym
- MFG-SNO
- Status last verified
- May 2022
- First submitted
- 29 Jun 2022
- Last updated
- 7 Oct 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Glycemic Control by Flash Monitoring of Glucose (MFG) in Malnourished Patients With Type 2 Diabetes and Oral Supplements: Standard Formula vs Specific Formula for Diabetes
- ClinicalTrials.gov ID
- NCT05443204
- Acronym / sponsor ID
- MFG-SNO / MFG SNO
- Conditions
- Diabetes Type 2, Malnutrition
- Keywords
- Diabetes type 2, Malnutrition, MFG
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y SaludUniversity, hospital or other
- Study start
- 7 Jul 2022 (actual)
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 31 May 2023 (estimated)
- First posted
- 5 Jul 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.
Evaluation of Glycemic Control by Flash Monitoring of Glucose (MFG) in Malnourished Patients With Type 2 Diabetes (MFG SNO)
Detailed description
In people with malnutrition and diabetes who require oral supplementation, there is no evidence clear when choosing a specific supplement for diabetes or a standard supplement. To date, there are no studies evaluating flash glucose monitoring in people with DM2 with supplements, nor studies comparing formulas specific for diabetes with standard formulas. Patients with type 2 diabetes, malnutrition and requiring oral nutritional supplements for 3 months will be included in the study.
A standard supplement (minimum 2 per day) will be prescribed for 2 weeks, an installation of the MFG system indicating that the scans are performed at start up, at the time and two hours after taking the oral supplement at home, as it doesn't happen anymore 8 hours without scanning to avoid losing information. After 14 days participants will go to consultation to download MFG data, assess acute response after taking of the supplement in the presence of health personnel (every 15 minutes for 4 hours). Investigators will change the sensor and nutritional supplement to a specific diabetes formula, after 14 days participants will come for MFG data download and to assess acute response after taking the supplement in the presence of healthcare personnel.
The results of the study will allow us to carry out a more appropriate treatment in this profile of patients, which is increasingly prevalent in our consultations.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Patients will be assigned in a 1:1 ratio
| Arm | Type | Receives |
|---|---|---|
| Standard Formula (Fortimel) | Experimental | Other: Fortimel energyFats 35% total caloric volume (VCT) Carbohydrates: 49% del VCT Proteins: 16% del VCT Density: 1.5 kcal/ ml |
| Specific formula for diabetes (Nutrision Advanced) | Experimental | Other: Nutrision Advanced Diason Energy HPFats: 46% del VCT (60% monounsaturated fatty acids) Carbohydrates: 31% del VCT Proteins: 21% del VFiber: 2% VCT (80% soluble y 20% insoluble) Density: 1.5kcal/ml |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with DM2 under follow-up by the Clinical Nutrition and Dietetics Unit (UNCYD) who present malnutrition or are at risk of malnutrition and require oral nutritional supplements, for a minimum estimated period of 3 months.
Key exclusion criteria (2 listed)
- Patients with DM1, steroid diabetes, pancreatic diabetes, DM2 treated with rapid insulin, glomerular filtration rate less than 30 mL/min/1.73m2, intolerance to the product, gastrectomy or gastroparesis.
- Patients who do not sign the consent informed.
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 |
|---|---|---|
| Fortimel energyStandard nutritional oral supplement | Other | Standard Formula (Fortimel) |
| Nutrision Advanced Diason Energy HPSpecifc nutritional oral supplement in diabetics patients | Other | Specific formula for diabetes (Nutrision Advanced) |
Primary outcome
MFG discharge - mean interstitial glucose
Time frame: During 14 days after taking the supplement
Interstitial glucose measured in mg/dl
MFG discharge - hyperglycaemia
Time frame: During 14 days after taking the supplement
hyperglycaemia measured in mg/dl
MFG discharge - hypoglycaemia
Time frame: During 14 days after taking the supplement
hypoglycaemia measured in mg/dl
MFG discharge - GMI
Time frame: During 14 days after taking the supplement
Measured in number of scans per day
MFG discharge - hypoglycaemic events
Time frame: During 14 days after taking the supplement
Measured in number and duration per day
1 secondary outcome
Postprandial glucose intersticial monitoringdiabetes specific supplement
Time frame: During the 4 hours after taking standard formula and the one specific for diabetes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2022.
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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.
Gabriel Olveira Fuster, MD, PhD. principal investigator
Hospital Regional Universitario de Málaga - FIMABIS
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fortimel energy and Nutrision Advanced Diason Energy HP in people with Diabetes Type 2 and Malnutrition, run by Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud at 1 site 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 2 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: status not confirmed, as of the sponsor's last update on 7 Oct 2022. 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 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Viyey Kishore Doulatram Gamgaram, MD, PhD. (951290343, viyu90@hotmail.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
MFG discharge - mean interstitial glucose (time frame: During 14 days after taking the supplement). The study lists 5 primary outcomes in all. 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 7 Oct 2022.