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De klinische studie NCT06832059 voor Type 2 diabetes is rekruterend. Bekijk de kaartweergave van de Klinische Studies Radar en de AI-ontdekkingstools voor alle details. Of stel hier een vraag. | ||
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Kaartweergave
Precision Nutrition Versus Standard Dietary Care: Continuous Glucose Monitoring as a Tool for Guided Nutrition Care in Type 2 Diabetes - The PRECISE-DIET Trial. -A Pilot Study 20 Dieet
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De klinische studie NCT06832059 is een interventioneel studie bij Type 2 diabetes met de status rekruterend. Het doel is om 20 deelnemers te includeren vanaf 18 november 2025. De studie wordt geleid door Steno Diabetes Center Copenhagen en de voltooiing is gepland op 31 augustus 2026. Laatste update op ClinicalTrials.gov: 10 februari 2026.
Beknopte samenvatting
The primary aim of this pilot study is to assess the feasibility of a 12-week dietary intervention combined with the use of CGM in adults with T2D. The results of the pilot study will provide insights into recruitment, design, and the effectiveness of the intervention for the future long-term (12-month) PRECISE-DIET STUDY
Uitgebreide beschrijving
In recent decades, there has been a significant rise in the development and use of glucose lowering drugs aimed at improving glycemic control in individuals with type 2 diabetes (T2D). Despite medical advancements, more than one-third of the danish population with T2D have a hemoglobin A1c (HbA1c) exceeding the recommended thresholds. One limiting factor in supporting individuals achieve their glycaemic target may be...Toon meer
Officiële titel
Precision Nutrition Versus Standard Dietary Care: Continuous Glucose Monitoring as a Tool for Guided Nutrition Care in Type 2 Diabetes - The PRECISE-DIET Trial. -A Pilot Study
Aandoeningen
Type 2 diabetesAndere studie-ID's
- H-24083559
NCT-ID
Startdatum (Werkelijk)
2025-11-18
Laatste update geplaatst
2026-02-10
Verwachte einddatum
2026-08-31
Inschrijving (Geschat)
20
Studietype
Interventioneel
FASE
N.v.t.
Status
Rekruterend
Trefwoorden
Type 2 diabetes
Dietary intervention
CGM
continuous glucose monitoring
Dietary intervention
CGM
continuous glucose monitoring
Primaire doel
Behandeling
Toewijzing
N.v.t.
Interventiemodel
Enkele groep
Blindering
Geen (Open-label)
Armen / Interventies
| Deelnemersgroep/Studiearm | Interventie/Behandeling |
|---|---|
ExperimenteelPrecise diet intervention The precise diet intervention for 12 weeks (n=20). | The precise diet intervention The intervention includes training and education in CGM use and reduction in overall carbohydrate intake guided by individualized flexible nutrition recommendations, with adjustments made according to postprandial blood glucose responses. Staff will guide participants in the daily carbohydrate intake with personalized adjustments to accommodate individual needs by the individuals. The primary goal is to minimize the ...Toon meer |
Primaire uitkomst
Secundaire uitkomst
| Uitkomstmaat | Beschrijving van de uitkomstmaat | Tijdsbestek |
|---|---|---|
Fidelity testing | Participants will be invited to a workshop to evaluate the intervention and its components. Procedures from fidelity testing will be applied in the evaluation. These specific topics will be evaluated:
* Study design
o Is the design appropriate? E.g., number of visits, CGM use, dietetic feedback?
* Sampling strategy
o E.g., how many participated, recruitment methods, sample diversity?
* Treatment receipt
* "What is learned?"
* Is the intervention relevant to and accepted by the participants?
* Treatment enactment
* What is actually used and done?
* Do participants' "behavioural skills" improve? | 12 weeks after baseline |
| Uitkomstmaat | Beschrijving van de uitkomstmaat | Tijdsbestek |
|---|---|---|
HbA1c (mmol/mol) | Assessed from blood samples | Measured at baseline and after 12 weeks |
Time in range (TIR) | Time spent in time in range 3.9 mmol/l - 10.0 mmol/l from CGM data | Measured at baseline and after 12 weeks |
Time above range (TAR) | Time spent in time above range 10.1-13.9 mmol/l from CGM data | Measured at baseline and after 12 weeks |
Time below range (TBR) | Time spent in time below range \<3.9 mmol/l from from CGM data | Measured at baseline and after 12 weeks |
Coefficient of variation (CV) | Percentage coefficient of variation in glucose differences | Measured at baseline and after 12 weeks |
Estimated HbA1c | Estimated HbA1c (14-days average of the CGM data) | Measured at baseline and after 12 weeks |
Body mass index (kg/m^2) | Calculated from body weight (kg) and height (m). | Measured at baseline and after 12 weeks |
Body weight (kg) | Measured on a digital scale | Measured at baseline and after 12 weeks |
Waist circumference (cm) | Measured using tape measure. | Measured at baseline and after 12 weeks |
Hip circumference (cm) | Measured using tape measure | Measured at baseline and after 12 weeks |
Systolic blood pressure (mmHg) | Measured under resting | Measured at baseline and after 12 weeks |
Diastolic blood pressure (mmHg) | Measured under resting | Measured at baseline and after 12 weeks |
Self-reported diabetes distress | Assessed from the Problem Areas in Diabetes Scale comprising of twenty emotional-distress questions. Each item can be rated from 0 to 5. | Measured at baseline and after 12 weeks |
Self-reported treatment satisfaction | Assessed from the questionnaire Diabetes Treatment Satisfaction Questionnaire (DTSQ). | Measured at baseline and after 12 weeks |
Dietary intake | Dietary intake (total energy intake and macronutrient composition based on 3-days' diet records) | Measured at baseline and after 12 weeks |
Deelname-assistent
Geschiktheidscriteria
Leeftijd van deelnemers
Volwassene, Oudere volwassene
Minimumleeftijd
18 Years
Geslachten die in aanmerking komen voor de studie
Allen
T2D
- Diabetes duration of ≥12 months
- ≥18 years of age
- HbA1c ≥58 mmol/mol
- Attending the SDCC outpatient clinic
- Provided voluntary signed informed consent.
- Inability to understand the patient information.
- Complications which do not permit to lowering HbA1c to <58 mmol/mol.
- Treatment with insulin.
- Low daily carbohydrate intake (defined as below 25 E% or 100 g/day) prior to study inclusion.
- Systematic use of corticosteroids.
- Using or requiring a specialized diet (e.g., kidney diet).
- Circumstances that affect HbA1c (e.g., liver disease and anaemia).
- Known or suspected drug or alcohol abuse (judged by the investigator).
- Pregnancy or breastfeeding or plans of pregnancy within the study period.
- Participation in other clinical trials.
Steno Diabetes Center CopenhagenVerantwoordelijke instantie
Bettina Ewers, Hoofdonderzoeker, Head of Nutrition and PhD, Steno Diabetes Center Copenhagen
Centraal Contactpersoon
Contact: Bettina Ewers, PhD, 0045 30912997, [email protected]
1 Studielocaties in 1 landen
Steno Diabetes Center Copenhagen, Herlev, 2730, Denmark
Bettina Ewers, PhD, Contact, 0045 30912997, [email protected]
Rekruterend