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Type 2 DiabetesNCT06832059

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

A study testing The precise diet intervention in people with Type 2 Diabetes, run by Steno Diabetes Center Copenhagen at 1 site in Denmark.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Type 2 Diabetes
What is being tested?
The precise diet intervention
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
1 siteDenmark
Study dates
18 Nov 2025to 30 Sep 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

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

Who may be able to join

  • T2D
  • Diabetes duration of ≥12 months
  • ≥18 years of age
  • HbA1c ≥58 mmol/mol
  • Attending the SDCC outpatient clinic
  • Provided voluntary signed informed consent.

Who cannot join

  • 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).
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  • 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.

Trial locations and contacts

1 site in 1 country.

Denmark1 site

  • Steno Diabetes Center Copenhagen

    Herlev, 2730

Other trials in Denmark

About this study

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

Read the detailed description

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

Conditions
Type 2 Diabetes
Being tested
The precise diet intervention
Keywords
Type 2 diabetes, Dietary intervention, CGM, continuous glucose monitoring
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.

  • The precise diet interventionOther

    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

Study groups in NCT06832059
Study groupRoleWhat they receive
Precise diet interventionExperimentalThe precise diet intervention for 12 weeks (n=20).
Receives: Other: The precise diet intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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
    • Is the design appropriate? E.g., number of visits, CGM use, dietetic feedback?
    • Sampling strategy
    • 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?

    Measured: 12 weeks after baseline

Secondary outcomes (15)

  1. HbA1c (mmol/mol)

    Assessed from blood samples

    Measured: Measured at baseline and after 12 weeks

  2. Time in range (TIR)

    Time spent in time in range 3.9 mmol/l - 10.0 mmol/l from CGM data

    Measured: Measured at baseline and after 12 weeks

  3. Time above range (TAR)

    Time spent in time above range 10.1-13.9 mmol/l from CGM data

    Measured: Measured at baseline and after 12 weeks

  4. Time below range (TBR)

    Time spent in time below range <3.9 mmol/l from from CGM data

    Measured: Measured at baseline and after 12 weeks

  5. Coefficient of variation (CV)

    Percentage coefficient of variation in glucose differences

    Measured: Measured at baseline and after 12 weeks

  6. Estimated HbA1c

    Estimated HbA1c (14-days average of the CGM data)

    Measured: Measured at baseline and after 12 weeks

  7. Body mass index (kg/m^2)

    Calculated from body weight (kg) and height (m).

    Measured: Measured at baseline and after 12 weeks

  8. Body weight (kg)

    Measured on a digital scale

    Measured: Measured at baseline and after 12 weeks

  9. Waist circumference (cm)

    Measured using tape measure.

    Measured: Measured at baseline and after 12 weeks

  10. Hip circumference (cm)

    Measured using tape measure

    Measured: Measured at baseline and after 12 weeks

  11. Systolic blood pressure (mmHg)

    Measured under resting

    Measured: Measured at baseline and after 12 weeks

  12. Diastolic blood pressure (mmHg)

    Measured under resting

    Measured: Measured at baseline and after 12 weeks

  13. 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: Measured at baseline and after 12 weeks

  14. Self-reported treatment satisfaction

    Assessed from the questionnaire Diabetes Treatment Satisfaction Questionnaire (DTSQ).

    Measured: Measured at baseline and after 12 weeks

  15. Dietary intake

    Dietary intake (total energy intake and macronutrient composition based on 3-days' diet records)

    Measured: Measured at baseline and after 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Feb 2025
  2. Study start18 Nov 2025
  3. Primary completion30 Sep 2026 (estimated)
  4. Study completion30 Sep 2026 (estimated)

Resources

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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
20 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06832059
Sponsor's protocol ID
H-24083559
Status last verified
Jun 2026
First submitted
9 Jan 2025
Last updated
1 Jul 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing The precise diet intervention in people with Type 2 Diabetes, run by Steno Diabetes Center Copenhagen at 1 site in Denmark.

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 6 inclusion and 10 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: under way, not looking for participants, as of the sponsor's last update on 1 Jul 2026. 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 Denmark. 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?

This study is still under way. Results are not available in the source record yet.

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?

Fidelity testing (time frame: 12 weeks after baseline). 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 NCT06832059.

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 1 Jul 2026.

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