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Trial · NCT06120881

Registered outcomes11

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

ListOutcomeTime frameDescription
PrimaryAcceptability of Higher Metformin Dose measured with the Acceptability of Intervention Measure (AIM)Measured at 3 months
The perception that a higher dose of Metformin is agreeable or satisfactory measured with the 4-item Acceptability of Intervention Measure (AIM). A 4-item measure of perceived intervention acceptability. Items are measured on a 5-point Likert scale (Completely Disagree-Completely Agree). Score is calculated mean. The greater the score, the better the acceptability.
PrimaryFeasibility of Higher Metformin Dose measured with the Feasibility of Intervention Measure (FIM)Measured at 3 months
The extent to which a higher dose Metformin study can be successfully carried out measured with 4-item Feasibility of Intervention Measure (FIM). A 4-item instrument to assess perceived intervention feasibility. Items are measured on a 5-point Likert scale (Completely Disagree-Completely Agree). Score is calculated mean. The greater the score, the better the feasibility.
SecondaryGlycemic ChangeBaseline (0) to 3 monthsChange in serum HbA1C at 3 months adjusted for the baseline value youth with T2D on higher dose of metformin compared to standard dose
SecondaryTime in target glucose rangeBaseline (0) to 3 monthsTime spent in target glucose range of 70 to 180 mg/dL
SecondaryTime above high glucose rangeBaseline (0) to 3 monthsPercent of readings and time \>250 mg/dL
SecondaryTime above glucose rangeBaseline (0) to 3 monthsPercent of readings and time 181-250 mg/dL
SecondaryTime in glucose rangeBaseline (0) to 3 monthsPercent of readings and time 70-180 mg/dL
SecondaryTime below glucose rangeBaseline (0) to 3 monthsPercent of readings and time 54-69 mg/dL
SecondaryTime below low glucose rangeBaseline (0) to 3 monthsPercent of readings and time \<54 mg/dl
SecondaryGlucose management indicatorBaseline (0) to 3 months
Continuous glucose monitoring (CGM) metric that indicates average blood glucose. Glucose Management Indicator (GMI) approximates the laboratory A1C level expected based on average glucose measured using CGM values. Average glucose is derived from 14 or more days of CGM readings.
SecondaryCo-efficient of variation of glucoseBaseline (0) to 3 monthsCGM metric that measures variability in CGM values

Source ClinicalTrials.govtrials-2026-11-12-0.5.0

Sources 3

  • ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
  • ClinicalTrials.govNo license stated
  • NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
  • ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
  • ClinicalTrials.govnone stated
  • NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

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