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New study aims to unlock secrets of blood sugar control before diabetes develops

NCT ID NCT07288372

Knowledge-focused Sponsor: Shanghai 6th People's Hospital Source: ClinicalTrials.gov ↗

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study will enroll about 225 adults aged 18-70 who are at risk for or may have early blood sugar problems, but not yet diagnosed with diabetes. Participants will wear a continuous glucose monitor for 10-14 days and take two at-home meal tests, followed by a standard glucose drink test at the hospital. The goal is to learn how home monitoring compares to hospital tests and how the body controls blood sugar, which could improve early detection and management of type 2 diabetes.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 225 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Dec 2025

An estimate. Start dates often move.

Expected to finish

Aug 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

This monocentric, prospective, observational study will enroll 225 adult participants (aged 18-70 years) who are at high risk for diabetes or present with abnormal glucose metabolism, but have not been previously diagnosed with diabetes. Participants must meet specific eligibility criteria, including having diabetes-related symptoms, impaired fasting glucose, elevated HbA1c in the pre-diabetes range, or established risk factors (e.g., obesity, family history of diabetes, hypertension, or dyslipidemia). Key Exclusion Criteria include a prior diagnosis of diabetes, use of medications affecting glucose metabolism, significant organ dysfunction, or pregnancy. Upon enrollment, all participants will undergo a standardized 75g Oral Glucose Tolerance Test (OGTT). Based on the OGTT results, they will be retrospectively categorized into three natural groups for comparative analysis: Normal Glucose Tolerance (NGT), Pre-Diabetes (Pre-DM), and Newly Diagnosed Type 2 Diabetes (T2DM).

Ages

18 to 70 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: To be eligible to participate in this study, an individual must meet ALL of the following criteria: * Is aged between 18 and 70 years, inclusive. * And meets at least ONE of the following conditions: * Presents with diabetes-related clinical symptoms or signs (e.g., unexplained ·polydipsia, polyphagia, polyuria, weight loss) and has been advised by a ·clinician to undergo an OGTT for diagnostic clarification. * Has indicators of abnormal glucose metabolism:Impaired Fasting Glucose (IFG): Fasting venous plasma glucose ≥ 6.1 mmol/L and \< 7.0 mmol/L.and/or Glycated hemoglobin (HbA1c) in the pre-diabetes range of 5.7% to 6.4%. * Has at least one of the following diabetes risk factors:Body Mass Index (BMI) ≥ 24 kg/m²；Has a first-degree relative (parent, sibling, or child) with a history of diabetes；Has a history of hypertension (or undergoing antihypertensive treatment) or dyslipidemia. Exclusion Criteria: * An individual who meets ANY of the following criteria will be excluded from participation in this study: * Previously diagnosed with diabetes. * Use of medications that significantly affect glucose metabolism or gastrointestinal hormones (e.g., GLP-1 receptor agonists, DPP-4 inhibitors, glucocorticoids) within a specified washout period prior to enrollment. * History of gastrointestinal surgery (e.g., gastrectomy) or chronic pancreatic disease. * Presence of severe hepatic or renal impairment (e.g., ALT \> 3 times the upper limit of normal, or eGFR \< 45 mL/min/1.73m²). * Pregnant or lactating women, or women planning to become pregnant during the study period. * Known allergy to soy (as the standardized meal may contain soy-based components).

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Conditions

The condition(s) this trial relates to.

glucose metabolism disease prediabetes syndrome type 2 diabetes mellitus

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Glucose metabolism disorders Type 2 diabetes

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  2. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

More trials for these conditions

Other studies related to the condition(s) this trial covers.