An interventional study of The precise diet intervention in Type 2 Diabetes, sponsored by Steno Diabetes Center Copenhagen. Active, not recruiting at 1 site in Denmark. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-01.
Sponsored by Steno Diabetes Center Copenhagen · Not applicable, Interventional, and Treatment
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
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 driven by substantial postprandial increases in plasma glucose levels, which is influenced by the quantity and type of carbohydrates in meals, underscoring the critical role of dietary interventions as an integral component of T2D management.
Recent studies have demonstrated that the use of continuous glucose monitors (CGMs), which allow individuals to track their glucose profiles continuously throughout the day, improves glycemic control in T2D patients. However, these studies often exclude dietary interventions, which could potentially yield greater improvements in blood glucose regulation.
Nutritional research in recent years has focused on dietary patterns such as low-fat diets, the paleo diet, and vegan diets. Nevertheless, these studies have not sufficiently addressed individualized dietary adjustments to mitigate postprandial glucose excursions, despite their substantial importance for glycemic control.
Several clinical studies have revealed significant inter-individual variations in glycemic responses to identical standardized meals, highlighting the necessity of a personalized approach to dietary recommendations, particularly with a focus on carbohydrate intake.
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
9,359 studies on the registry are indexed under Diabetes Mellitus, Type 2; 1,318 are open to participants now.
This study's planned enrollment of 20 is below the median of 80 across 7,525 interventional studies indexed under Diabetes Mellitus, Type 2.
Browse Diabetes Mellitus, Type 2 studies →Steno Diabetes Center Copenhagen is the lead sponsor of 111 studies on the registry; 22 are open to participants now.
Counted across the registry records on this site, refreshed daily.
T2D
Exclusion Criteria:
The precise diet intervention for 12 weeks (n=20).
Other: 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 participant's time spent above 10 mmol/l
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?
Time frame: 12 weeks after baseline
HbA1c (mmol/mol)
Assessed from blood samples
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Measured at baseline and after 12 weeks
Coefficient of variation (CV)
Percentage coefficient of variation in glucose differences
Time frame: Measured at baseline and after 12 weeks
Estimated HbA1c
Estimated HbA1c (14-days average of the CGM data)
Time frame: Measured at baseline and after 12 weeks
Body mass index (kg/m^2)
Calculated from body weight (kg) and height (m).
Time frame: Measured at baseline and after 12 weeks
Body weight (kg)
Measured on a digital scale
Time frame: Measured at baseline and after 12 weeks
Waist circumference (cm)
Measured using tape measure.
Time frame: Measured at baseline and after 12 weeks
Hip circumference (cm)
Measured using tape measure
Time frame: Measured at baseline and after 12 weeks
Systolic blood pressure (mmHg)
Measured under resting
Time frame: Measured at baseline and after 12 weeks
Diastolic blood pressure (mmHg)
Measured under resting
Time frame: 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.
Time frame: Measured at baseline and after 12 weeks
Self-reported treatment satisfaction
Assessed from the questionnaire Diabetes Treatment Satisfaction Questionnaire (DTSQ).
Time frame: Measured at baseline and after 12 weeks
Dietary intake
Dietary intake (total energy intake and macronutrient composition based on 3-days' diet records)
Time frame: Measured at baseline and after 12 weeks
Changes in glucose lowering drugs
Medication status, change in doses or discontinuation of medicine
Time frame: Measured at baseline and after 12 weeks
Personality trait assesment
Assesed fromt the BIG FIVE Inventory questionnaire (BFI-44). Comprising of 44 items.
Time frame: Baseline
Physical activity
Physical activity levels measured by X3 accelerometers
Time frame: Measured at baseline and after 12 weeks
Plan to share: No
No publications or documents are linked to this record.
This study is active, not recruiting, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.
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Steno Diabetes Center Copenhagen