An interventional study of Carbohydrate-counting-based prandial rapid-acting insulin dosing and Flexible fixed mealtime rapid-acting insulin dosing based on percentage of meal consumed in Diabetes Type 2 on Insulin, Hypoglycemia (Diabetic) and Hyperglycemia Due to Type 2 Diabetes Mellitus, sponsored by Mayo Clinic. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-08.
Sponsored by Mayo Clinic · Not applicable, Interventional, and Treatment
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.
706 studies on the registry are indexed under Hypoglycemia; 94 are open to participants now.
This study's planned enrollment of 500 is above the median of 28 across 534 interventional studies indexed under Hypoglycemia.
Browse Hypoglycemia studies →Mayo Clinic is the lead sponsor of 3,269 studies on the registry; 672 are open to participants now.
Of its 452 completed or terminated interventional studies of FDA-regulated products, 321 (71%) have results posted.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion criteria
Participants randomized to this arm will receive prandial rapid-acting insulin using the standard of care carbohydrate-counting workflow. Mealtime insulin dosing will be individualized based on the ordered insulin-to-carbohydrate ratio, carbohydrate intake documented by nursing staff, and any correctional insulin needs.
Other: Carbohydrate-counting-based prandial rapid-acting insulin dosing
Participants randomized to this arm will receive prandial rapid-acting insulin using a flexible fixed-dose workflow based on the percentage of meal consumed. The mealtime insulin dose will be selected from a pre-specified fixed dose and adjusted according to observed meal intake.
Other: Flexible fixed mealtime rapid-acting insulin dosing based on percentage of meal consumed
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.
Percentage of Time With Glucose in Target Range of 100 to 180 mg/dL
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 Hyperglycemia Events Greater Than 300 mg/dL
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 Hyperglycemia Events Greater Than 300 mg/dL Per Patient-Day
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
Percentage of Time With Glucose Greater Than 300 mg/dL
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 Hypoglycemia Events Less Than 70 mg/dL
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 Hypoglycemia Events Less Than 70 mg/dL Per Patient-Day
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 Severe Hypoglycemia Events Less Than 54 mg/dL
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 Severe Hypoglycemia Events Less Than 54 mg/dL Per Patient-Day
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
Percentage of Time With Glucose Less Than 70 mg/dL
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
Percentage of Time With Glucose Less Than 54 mg/dL
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
Average Glucose During Hospitalization
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
Hospital Length of Stay
Duration of hospitalization after randomization, reported in days
Time frame: From randomization to hospital discharge, up to 30 days
All-Cause 30-Day Hospital Readmission
Occurrence of all-cause hospital readmission within 30 days after hospital discharge.
Time frame: Within 30 days after hospital discharge
All-Cause 30-Day Emergency Room Visit
Occurrence of an all-cause emergency room visit within 30 days after hospital discharge.
Time frame: Within 30 days after hospital discharge
All-Cause Mortality
Occurrence of death from any cause during study participation or within 30 days after completion of study participation.
Time frame: From randomization through 30 days after completion of study participation
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Plan to share: No
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