Pre-diabetesOGTT-CGMNCT06862128
OGTT at Home Using CGM vs at the Clinic
A study testing OGTT at home using CGM and OGTT at the clinic in people with Pre-diabetes and Diabetes, run by Linkoeping University at 3 sites in Sweden.
Trial summary
This randomized, crossover study evaluates the feasibility and accuracy of a self-administered oral glucose tolerance test (OGTT) at home using continuous glucose monitoring (CGM) compared to a standard clinic-based OGTT. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Pre-diabetes, Diabetes
- What is being tested?
- OGTT at home using CGM and OGTT at the clinic
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 3 sitesSweden
- Study dates
- 11 Jun 2025to 31 Dec 2040
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Prediabetes indicated by any of the following values:
- - Fasting venous plasma glucose ≥5.6 but <7.0 mmol/L
- - HbA1c ≥39 but <48 mmol/mol
- Access to a smart phone which is compatible with the CGM application and has working Bluetooth connectivity
- Ability to read and respond to online instructions and questionnaires in Swedish.
Who cannot join
- T2D indicated by ≥2 of the following values, measured at different occasions or through different analyses:
- - Fasting venous plasma glucose ≥7.0 mmol/L
- - Non-fasting venous plasma glucose value ≥11.1 mmol/L
- - HbA1c ≥48 mmol/mol
- Previous bariatric surgery e.g., gastric by-pass or gastric sleeve surgery
- Body mass index <20 kg/m2
Show all 12Show fewer
- Body weight <43 kg
- Current pregnancy
- Need of regular use of GLP-1 receptor agonists, SGLT-2 inhibitors, acetaminophen or ascorbic acid supplements during the study period
- Fear of needle sticks
- Shift work during the study period
- Involvement in the study design, data collection, analysis, or participant recruitment.
Trial locations and contacts
3 sites in 1 country.
Sweden3 sites
Primary Health Care Center Bra Liv Rosenhälsan
Huskvarna, Jönköping County, 55185
Primary Care Center Vårdcentralen Kärna
Linköping, Östergötland County, 58662
Primary Health Care Center Cityhälsan Centrum
Norrköping, Norrköping, 60239
About this study
Official title: Oral Glucose Tolerance Test at Home With Continuous Glucose Monitoring vs Standard Clinic-based Testing
This randomized, crossover study evaluates the feasibility and accuracy of a self-administered oral glucose tolerance test (OGTT) at home using continuous glucose monitoring (CGM) compared to a standard clinic-based OGTT. Participants with prediabetes will undergo both home-based and clinic-based OGTTs, with glucose levels measured via CGM and venous plasma glucose. The primary outcome is the correlation between CGM-based glucose values and standard OGTT results. Secondary outcomes include diagnostic agreement, metabolic hormone associations, and feasibility of home-based testing as a diagnostic tool for dysglycemia.
Read the detailed description
This study aims to evaluate the feasibility, accuracy, and diagnostic utility of a self-administered oral glucose tolerance test (OGTT) at home using continuous glucose monitoring (CGM) compared to a standard clinic-based OGTT.
Study Design Type: Randomized, crossover study Participants: 70 adults with prediabetes Intervention: Each participant will complete both a home-based OGTT with CGM and a clinic-based OGTT with venous plasma glucose measurement.
Primary Objective To evaluate the diagnostic accuracy and agreement of the 2-hour CGM glucose value from a home OGTT compared with the 2-hour venous plasma glucose value from a clinic OGTT.
Secondary Objectives To evaluate the lag-adjusted CGM timing and reproducibility across 2 home OGTTs.
Methods Participants will be randomized into two groups: one starting with a clinic-based OGTT, the other with a home-based OGTT, followed by a crossover period. CGM will continuously monitor glucose responses, and standard venous plasma glucose measurements will serve as the reference method.
Clinical Relevance A validated home-based OGTT using CGM could improve access to glucose tolerance testing, reduce patient burden, and enhance early detection of dysglycemia.
- Conditions
- Pre-diabetes, Diabetes
- Being tested
- OGTT at home using CGM, OGTT at the clinic
- Keywords
- Pre-diabetes, Diabetes, Oral glucose tolerance test, Continuous glucose monitoring, Glucose
- Medical subject headings
- Glucose Intolerance, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OGTT at home using CGMDiagnostic test
Also called OGTT-home
OGTT at home using CGM
OGTT at the clinicDiagnostic test
Also called OGTT-clinic
OGTT at the clinic
| Study group | Role | What they receive |
|---|---|---|
| OGTT at the clinic then at home | Experimental | OGTT at the clinic then at home Receives: Diagnostic Test: OGTT at home using CGM; Diagnostic Test: OGTT at the clinic |
| OGTT at home then at the clinic | Experimental | OGTT at home then at the clinic Receives: Diagnostic Test: OGTT at home using CGM; Diagnostic Test: OGTT at the clinic |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic accuracy of the 2-hour CGM glucose value during home-based OGTT compared with 2-hour venous plasma glucose during clinic-based OGTT
The diagnostic accuracy of the 2-hour interstitial glucose measured by CGM during a home-based oral glucose tolerance test (OGTT) will be evaluated against the 2-hour venous plasma glucose obtained during a clinic-based OGTT (reference standard) for the classification of normoglycemia, prediabetes, and diabetes. The 2-hour CGM value will be defined as the first CGM recording at or within 5 minutes after the 2-hour timepoint (i.e., between 120 and 125 minutes).
Diagnostic accuracy will be assessed using sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV), and Cohen's kappa coefficient for overall classification agreement, each reported with 95% CIs. Systematic bias and limits of agreement between the two continuous glucose measurements will further be assessed using Bland-Altman analysis.
Measured: 2 hours after the start of the OGTT
Secondary outcomes (2)
Diagnostic accuracy of the lag-adjusted 2-hour CGM glucose value during home-based OGTT compared with 2-hour venous plasma glucose during clinic-based OGTT
The diagnostic accuracy of a lag-adjusted CGM glucose value during a home-based oral glucose tolerance test (OGTT) will be evaluated against the 2-hour venous plasma glucose during a clinic-based OGTT (reference standard) for the classification of normoglycemia, prediabetes, and diabetes. The lag-adjusted timepoint will be identified from the clinic-based OGTT as the CGM recording between 120 and 140 minutes showing the highest concordance with the 2-hour venous plasma glucose, assessed using Lin's concordance correlation coefficient (CCC), and applied accordingly during the home-based OGTT. Diagnostic accuracy will be assessed using sensitivity, specificity, PPV, NPV, and Cohen's kappa, each with 95% CIs, and Bland-Altman analysis will be used to assess systematic bias and limits of agreement.
Measured: 0-20 minutes after the 2-hour timepoint of the OGTT (lag-adjusted)
Reproducibility of home-based OGTT using CGM
Reproducibility of the 2-hour CGM glucose value across the two home-based OGTTs will be assessed using intraclass correlation coefficients (ICC), and agreement in glycemic classification (normoglycemia, prediabetes, and diabetes) will be assessed using weighted Cohen's kappa. Both the unadjusted and lag-adjusted 2-hour CGM values will be evaluated.
Measured: 2 hours and 2 hours plus 0-20 minutes lag-adjustment after the start of the OGTT
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2025
- Study start11 Jun 2025
- Primary completion21 May 2026
- Study completion31 Dec 2040 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pre-diabetesStudies of the same condition, open and under way.
- More trials run by Linkoeping UniversityThe sponsor's other registered studies.
- 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Linkoeping University
- Sponsor type
- Other government
- Collaborators
- Region Jönköping County, Region Östergötland
- Responsible party
- Principal investigator, Peder af Geijerstam, Linkoeping University
- Investigators
- Peder af Geijerstam, MD, PhD, Principal investigator, Linkoeping University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06862128
- Sponsor's protocol ID
- ogtt_cgm
- Acronym
- OGTT-CGM
- Status last verified
- Aug 2026
- First submitted
- 1 Mar 2025
- Last updated
- 5 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: If suitable according to ethical guidelines.
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oral Glucose Tolerance Test at Home With Continuous Glucose Monitoring vs Standard Clinic-based Testing
- ClinicalTrials.gov ID
- NCT06862128
- Acronym / sponsor ID
- OGTT-CGM / ogtt_cgm
- Conditions
- Pre-diabetes, Diabetes
- Keywords
- Pre-diabetes, Diabetes, Oral glucose tolerance test, Continuous glucose monitoring, Glucose
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Linkoeping UniversityOther government
- Collaborators
- Region Jönköping County, Region Östergötland
- Study start
- 11 Jun 2025 (actual)
- Primary completion
- 21 May 2026 (actual)
- Study completion
- 31 Dec 2040 (estimated)
- First posted
- 6 Mar 2025 (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.
This randomized, crossover study evaluates the feasibility and accuracy of a self-administered oral glucose tolerance test (OGTT) at home using continuous glucose monitoring (CGM) compared to a standard clinic-based OGTT. Participants with prediabetes will undergo both home-based and clinic-based OGTTs, with glucose levels measured via CGM and venous plasma glucose. The primary outcome is the correlation between CGM-based glucose values and standard OGTT results. Secondary outcomes include diagnostic agreement, metabolic hormone associations, and feasibility of home-based testing as a diagnostic tool for dysglycemia.
Detailed description
This study aims to evaluate the feasibility, accuracy, and diagnostic utility of a self-administered oral glucose tolerance test (OGTT) at home using continuous glucose monitoring (CGM) compared to a standard clinic-based OGTT.
Study Design Type: Randomized, crossover study Participants: 70 adults with prediabetes Intervention: Each participant will complete both a home-based OGTT with CGM and a clinic-based OGTT with venous plasma glucose measurement.
Primary Objective To evaluate the diagnostic accuracy and agreement of the 2-hour CGM glucose value from a home OGTT compared with the 2-hour venous plasma glucose value from a clinic OGTT.
Secondary Objectives To evaluate the lag-adjusted CGM timing and reproducibility across 2 home OGTTs.
Methods Participants will be randomized into two groups: one starting with a clinic-based OGTT, the other with a home-based OGTT, followed by a crossover period. CGM will continuously monitor glucose responses, and standard venous plasma glucose measurements will serve as the reference method.
Clinical Relevance A validated home-based OGTT using CGM could improve access to glucose tolerance testing, reduce patient burden, and enhance early detection of dysglycemia.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| OGTT at the clinic then at home | Experimental | Diagnostic Test: OGTT at home using CGM, Diagnostic Test: OGTT at the clinicOGTT at the clinic then at home |
| OGTT at home then at the clinic | Experimental | Diagnostic Test: OGTT at home using CGM, Diagnostic Test: OGTT at the clinicOGTT at home then at the clinic |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Prediabetes indicated by any of the following values:
- - Fasting venous plasma glucose ≥5.6 but <7.0 mmol/L
- - HbA1c ≥39 but <48 mmol/mol
- Access to a smart phone which is compatible with the CGM application and has working Bluetooth connectivity
- Ability to read and respond to online instructions and questionnaires in Swedish.
Key exclusion criteria (12 listed)
- T2D indicated by ≥2 of the following values, measured at different occasions or through different analyses:
- - Fasting venous plasma glucose ≥7.0 mmol/L
- - Non-fasting venous plasma glucose value ≥11.1 mmol/L
- - HbA1c ≥48 mmol/mol
- Previous bariatric surgery e.g., gastric by-pass or gastric sleeve surgery
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 |
|---|---|---|
| OGTT at home using CGMAlso: OGTT-homeOGTT at home using CGM | Diagnostic test | OGTT at home then at the clinic, OGTT at the clinic then at home |
| OGTT at the clinicAlso: OGTT-clinicOGTT at the clinic | Diagnostic test | OGTT at home then at the clinic, OGTT at the clinic then at home |
Primary outcome
Diagnostic accuracy of the 2-hour CGM glucose value during home-based OGTT compared with 2-hour venous plasma glucose during clinic-based OGTT
Time frame: 2 hours after the start of the OGTT
The diagnostic accuracy of the 2-hour interstitial glucose measured by CGM during a home-based oral glucose tolerance test (OGTT) will be evaluated against the 2-hour venous plasma glucose obtained during a clinic-based OGTT (reference standard) for the classification of normoglycemia, prediabetes, and diabetes. The 2-hour CGM value will be defined as the first CGM recording at or within 5 minutes after the 2-hour timepoint (i.e., between 120 and 125 minutes). Diagnostic accuracy will be assessed using sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV), and Cohen's kappa coefficient for overall classification agreement, each reported with 95% CIs. Systematic bias and limits of agreement between the two continuous glucose measurements will further be assessed using Bland-Altman analysis.
2 secondary outcomes
Diagnostic accuracy of the lag-adjusted 2-hour CGM glucose value during home-based OGTT compared with 2-hour venous plasma glucose during clinic-based OGTT
Time frame: 0-20 minutes after the 2-hour timepoint of the OGTT (lag-adjusted)
Reproducibility of home-based OGTT using CGM
Time frame: 2 hours and 2 hours plus 0-20 minutes lag-adjustment after the start of the OGTT
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2026.
- Individual participant dataSharing planned: Undecided. If suitable according to ethical guidelines.
Related trials for Pre-diabetes
RecruitingObservational study
Food-i-Sense Analytics: Integrating AI Into Continuous Glucose Monitoring Data Analysis for Precision Nutrition.
Prediabetes (Insulin Resistance, Impaired Glucose Tolerance), Artificial Intelligence Mobile Application
RecruitingPhase 3
A Study of Orforglipron in Participants With Overweight at Risk of Development of Obesity-Related Complications or Progression to Class 1 Obesity
Overweight, Prediabetic State
Enrolling by invitationEarly Phase 1
Truway Diagnostic Tools in Primary Care
Chronic Disease, Type 2 Diabetes Mellitus (T2DM), Obesity, Overweight
RecruitingObservational study
Estimated Risk of Preeclampsia in the First Trimester and Its Association With Subclinical Atherosclerosis and Cardiovascular Risk in Women With Type 1 Diabetes
Type 1 Diabetes, Preeclampsia
Recruiting
CGM-Enhanced DPP to Prevent Type 2 Diabetes in Adults With Prediabetes
PreDiabetes
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.
Peder af Geijerstam, MD, PhD principal investigator
Linkoeping University
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing OGTT at home using CGM and OGTT at the clinic in people with Pre-diabetes and Diabetes, run by Linkoeping University at 3 sites in Sweden.
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 5 inclusion and 12 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 5 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Sweden. 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?
Diagnostic accuracy of the 2-hour CGM glucose value during home-based OGTT compared with 2-hour venous plasma glucose during clinic-based OGTT (time frame: 2 hours after the start of the OGTT). 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 5 Aug 2026.