Recruiting NA Pre-diabetes

Compares treatment options for Pre-diabetes

Official title OGTT at Home Using CGM vs at the Clinic

ClinicalTrials.gov ID: NCT06862128

What this study is testing

What it's 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.
  • Which group you join is decided by chance.

A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.

Who can take part

Ages 18 to 70

You may be able to join if

  • Prediabetes indicated by ≥2 of the following values, measured at separate occasions or through different analyses during the past 2 years:
  • \- Fasting venous plasma glucose ≥6.1 but ≤6.9 mmol/L
  • \- Non-fasting venous plasma glucose ≥7.8 but ≤11.0 mmol/L
  • \- HbA1c ≥39 but ≤47 mmol/mol
  • Access to a smart phone which is compatible with the CGM application and has working Bluetooth connectivity

You likely can't join if

  • 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
See the full eligibility criteria
Who can join
  • Prediabetes indicated by ≥2 of the following values, measured at separate occasions or through different analyses during the past 2 years:
  • \- Fasting venous plasma glucose ≥6.1 but ≤6.9 mmol/L
  • \- Non-fasting venous plasma glucose ≥7.8 but ≤11.0 mmol/L
  • \- HbA1c ≥39 but ≤47 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.
What rules you out
  • 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
  • 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.

The study team makes the final eligibility decision.

Where it's taking place

  • Huskvarna, Jönköping County, Sweden
  • Norrköping, Norrköping, Sweden
  • Linköping, Östergötland County, Sweden

Questions & answers

Do participants get paid in this trial?

This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.

Is it free to join, and do I need insurance?

Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.

How long does this study last?

The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.

Who can join this trial?

This study is enrolling all sexes, 18 years to 70 years. The study team makes the final eligibility decision.

Where is this trial taking place?

Study sites include Huskvarna, Jönköping County, Sweden; Norrköping, Norrköping, Sweden; Linköping, Östergötland County, Sweden. Enter your location above to see the nearest site and check your eligibility.

Explore other conditions

BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.