Clinical trial NCT05443204: Evaluation of Glycemic Control by Flash Monitoring of Glucose (MFG) in Malnourished Patients With Type 2 Diabetes
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Diabetes Type 2
Malnutrition
Keywords: Diabetes type 2
Malnutrition
MFG
Lead sponsor: Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud
Sponsor class: OTHER
First posted: 2022-07-05
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Patients will be assigned in a 1:1 ratio
Primary purpose: TREATMENT

Brief summary: 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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: MFG discharge - mean interstitial glucose
timeFrame: During 14 days after taking the supplement
measure: MFG discharge - hyperglycaemia
timeFrame: During 14 days after taking the supplement
measure: MFG discharge - hypoglycaemia
timeFrame: During 14 days after taking the supplement
measure: MFG discharge - GMI
timeFrame: During 14 days after taking the supplement
measure: MFG discharge - hypoglycaemic events
timeFrame: During 14 days after taking the supplement
Secondary outcomes:
measure: Postprandial glucose intersticial monitoringdiabetes specific supplement
timeFrame: During the 4 hours after taking standard formula and the one specific for diabetes
Other outcomes:
Locations:
city: Málaga
country: Spain
facility: Hospital Regional Universitario de Málaga
Study officials:
affiliation: Hospital Regional Universitario de Málaga - FIMABIS
name: Gabriel Olveira Fuster, MD, PhD.
role: PRINCIPAL_INVESTIGATOR
References: