NCT Number: NCT07808398
The study compares two current practices for calculating insulin dose for admitted patients: flexible fixed mealtime dosing based on percent of meal eaten and carbohydrate counting based on amount of carbohydrates eaten.
Trial opening soon.
Get Notified18 year and older
All sexes
Interventional
Not applicable
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
For each meal, the provider enters an insulin-to-carbohydrate ratio in the EHR. After the meal, nursing staff document the grams of carbohydrates consumed. The EHR calculates the rapid-acting insulin dose using the ordered insulin-to-carbohydrate ratio, along with any correctional insulin dose based on the pre-meal glucose value. The calculated insulin dose is then administered as soon as possible after meal completion.
For each meal, the EHR calculates a full fixed prandial rapid-acting insulin dose from the provider-entered insulin-to-carbohydrate ratio, assuming a full meal contains 75 grams of carbohydrates and rounding to the nearest whole-unit dose according to the protocol. After the meal, nursing staff document whether the participant consumed 0%, 25%, 50%, 75%, or 100% of the meal. The EHR then instructs nursing staff to administer the corresponding proportion of the fixed dose as soon as possible after meal completion.
Time frame: From randomization to hospital discharge, up to 30 days
Patient-level percentage of time that glucose is within the target range of 100 to 180 mg/dL. This measure will be calculated using all glucose values obtained from randomization to discharge. For each patient, the time within range will be calculated using linear interpolation between consecutive measurements. For the percentage calculation, the numerator will be the calculated time within range, and the denominator will be the total time from the first glucose measurement after randomization to the last glucose measurement before discharge.
Time frame: From randomization to hospital discharge, up to 30 days
Number of glucose values greater than 300 mg/dL from randomization to hospital discharge.
Time frame: From randomization to hospital discharge, up to 30 days
Rate of glucose values greater than 300 mg/dL, calculated as the number of hyperglycemia events divided by the number of patient-days from randomization to hospital discharge.
Time frame: From randomization to hospital discharge, up to 30 days
Patient-level percentage of time that glucose is greater than 300 mg/dL, calculated using available glucose measurements from randomization to hospital discharge with linear interpolation between consecutive measurements.
Time frame: From randomization to hospital discharge, up to 30 days
Number of glucose values less than 70 mg/dL from randomization to hospital discharge.
Time frame: From randomization to hospital discharge, up to 30 days
Rate of glucose values less than 70 mg/dL, calculated as the number of hypoglycemia events divided by the number of patient-days from randomization to hospital discharge.
Time frame: From randomization to hospital discharge, up to 30 days
Number of glucose values less than 54 mg/dL from randomization to hospital discharge.
Time frame: From randomization to hospital discharge, up to 30 days
Rate of glucose values less than 54 mg/dL, calculated as the number of severe hypoglycemia events divided by the number of patient-days from randomization to hospital discharge.
Time frame: From randomization to hospital discharge, up to 30 days
Patient-level percentage of time that glucose is less than 70 mg/dL, calculated using available glucose measurements from randomization to hospital discharge with linear interpolation between consecutive measurements.
Time frame: From randomization to hospital discharge, up to 30 days
Patient-level percentage of time that glucose is less than 54 mg/dL, calculated using available glucose measurements from randomization to hospital discharge with linear interpolation between consecutive measurements.
Time frame: From randomization to hospital discharge, up to 30 days
Mean glucose value during hospitalization, calculated using all point-of-care capillary and pertinent serum glucose values collected from randomization to hospital discharge.
Time frame: From randomization to hospital discharge, up to 30 days
Duration of hospitalization after randomization, reported in days
Time frame: Within 30 days after hospital discharge
Occurrence of all-cause hospital readmission within 30 days after hospital discharge.
Time frame: Within 30 days after hospital discharge
Occurrence of an all-cause emergency room visit within 30 days after hospital discharge.
Time frame: From randomization through 30 days after completion of study participation
Occurrence of death from any cause during study participation or within 30 days after completion of study participation.
Contact information is provided by the study sponsor or research team.
Mayo Clinic
Other
Comparing Glycemic Outcomes of Carbohydrate Counting vs. Fixed Mealtime Insulin Dosing in Hospitalized Patients With Hyperglycemia: an EHR-embedded Randomized Controlled Study
Acronym: MEND
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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