Diabetes Type 2 on InsulinMENDNCT07808398
Comparing Glycemic Outcomes of Carbohydrate Counting vs. Fixed Mealtime Insulin Dosing in Hospitalized Patients With Hyperglycemia
A study testing Carbohydrate-counting-based prandial rapid-acting insulin dosing and Flexible fixed mealtime rapid-acting insulin dosing based on percentage of meal consumed in people with Diabetes Type 2 on Insulin and Hypoglycemia (Diabetic), run by Mayo Clinic.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes Type 2 on Insulin, Hypoglycemia (Diabetic), Hyperglycemia Due to Type 2 Diabetes Mellitus
- What is being tested?
- Carbohydrate-counting-based prandial rapid-acting insulin dosing and Flexible fixed mealtime rapid-acting insulin dosing based on percentage of meal consumed
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- No sites listed yet
- Study dates
- Oct 2026to May 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults ≥18 years
- Admitted to non-ICU units
- Require scheduled prandial insulin as part of basal-bolus insulin therapy with CC.
Who cannot join
- History of type 1 DM
- History of total pancreatectomy
- Use of pre-admission CC for prandial insulin administration
- Critical illness requiring ICU admission at time of recruitment.
- Admission to psychiatry services
- Pregnancy
- All forms of enteral/tube feeding or parenteral nutrition at recruitment
- Observation status at time of recruitment
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Comparing Glycemic Outcomes of Carbohydrate Counting vs. Fixed Mealtime Insulin Dosing in Hospitalized Patients With Hyperglycemia: an EHR-embedded Randomized Controlled Study
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.
- Conditions
- Diabetes Type 2 on Insulin, Hypoglycemia (Diabetic), Hyperglycemia Due to Type 2 Diabetes Mellitus
- Being tested
- Carbohydrate-counting-based prandial rapid-acting insulin dosing, Flexible fixed mealtime rapid-acting insulin dosing based on percentage of meal consumed
- Medical subject headings
- Hypoglycemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Carbohydrate-counting-based prandial rapid-acting insulin dosingOther
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.
Flexible fixed mealtime rapid-acting insulin dosing based on percentage of meal consumedOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Carbohydrate-Counting-Based Prandial Insulin Dosing | Active comparator | 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. Receives: Other: Carbohydrate-counting-based prandial rapid-acting insulin dosing |
| Flexible Fixed Mealtime Insulin Dosing | Experimental | 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. Receives: Other: Flexible fixed mealtime rapid-acting insulin dosing based on percentage of meal consumed |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From randomization to hospital discharge, up to 30 days
Secondary outcomes (14)
Number of Hyperglycemia Events Greater Than 300 mg/dL
Number of glucose values greater than 300 mg/dL from randomization to hospital discharge.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: From randomization to hospital discharge, up to 30 days
Hospital Length of Stay
Duration of hospitalization after randomization, reported in days
Measured: 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.
Measured: 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.
Measured: 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.
Measured: From randomization through 30 days after completion of study participation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2026
- Study startOct 2026 (estimated)
- Primary completionApr 2027 (estimated)
- Study completionMay 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Type 2 on InsulinStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sneha Mohan, Mayo Clinic
- Investigators
- Sneha Mohan, MBBS, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07808398
- Sponsor's protocol ID
- 25-014608
- Acronym
- MEND
- Status last verified
- Sep 2026
- First submitted
- 2 Sep 2026
- Last updated
- 8 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing Glycemic Outcomes of Carbohydrate Counting vs. Fixed Mealtime Insulin Dosing in Hospitalized Patients With Hyperglycemia: an EHR-embedded Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT07808398
- Acronym / sponsor ID
- MEND / 25-014608
- Conditions
- Diabetes Type 2 on Insulin, Hypoglycemia (Diabetic), Hyperglycemia Due to Type 2 Diabetes Mellitus
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- Oct 2026 (estimated)
- Primary completion
- Apr 2027 (estimated)
- Study completion
- May 2027 (estimated)
- First posted
- 8 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Carbohydrate-Counting-Based Prandial Insulin Dosing | Active comparator | Other: Carbohydrate-counting-based prandial rapid-acting insulin dosingParticipants 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. |
| Flexible Fixed Mealtime Insulin Dosing | Experimental | Other: Flexible fixed mealtime rapid-acting insulin dosing based on percentage of meal consumedParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adults ≥18 years
- Admitted to non-ICU units
- Require scheduled prandial insulin as part of basal-bolus insulin therapy with CC.
Key exclusion criteria (8 listed)
- History of type 1 DM
- History of total pancreatectomy
- Use of pre-admission CC for prandial insulin administration
- Critical illness requiring ICU admission at time of recruitment.
- Admission to psychiatry services
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Carbohydrate-counting-based prandial rapid-acting insulin dosingFor 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. | Other | Carbohydrate-Counting-Based Prandial Insulin Dosing |
| Flexible fixed mealtime rapid-acting insulin dosing based on percentage of meal consumedFor 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. | Other | Flexible Fixed Mealtime Insulin Dosing |
Primary outcome
Percentage of Time With Glucose in Target Range of 100 to 180 mg/dL
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.
14 secondary outcomes
Number of Hyperglycemia Events Greater Than 300 mg/dL
Time frame: From randomization to hospital discharge, up to 30 days
Rate of Hyperglycemia Events Greater Than 300 mg/dL Per Patient-Day
Time frame: From randomization to hospital discharge, up to 30 days
Percentage of Time With Glucose Greater Than 300 mg/dL
Time frame: From randomization to hospital discharge, up to 30 days
Number of Hypoglycemia Events Less Than 70 mg/dL
Time frame: From randomization to hospital discharge, up to 30 days
Rate of Hypoglycemia Events Less Than 70 mg/dL Per Patient-Day
Time frame: From randomization to hospital discharge, up to 30 days
Number of Severe Hypoglycemia Events Less Than 54 mg/dL
Time frame: From randomization to hospital discharge, up to 30 days
Rate of Severe Hypoglycemia Events Less Than 54 mg/dL Per Patient-Day
Time frame: From randomization to hospital discharge, up to 30 days
Percentage of Time With Glucose Less Than 70 mg/dL
Time frame: From randomization to hospital discharge, up to 30 days
Percentage of Time With Glucose Less Than 54 mg/dL
Time frame: From randomization to hospital discharge, up to 30 days
Average Glucose During Hospitalization
Time frame: From randomization to hospital discharge, up to 30 days
Hospital Length of Stay
Time frame: From randomization to hospital discharge, up to 30 days
All-Cause 30-Day Hospital Readmission
Time frame: Within 30 days after hospital discharge
All-Cause 30-Day Emergency Room Visit
Time frame: Within 30 days after hospital discharge
All-Cause Mortality
Time frame: From randomization through 30 days after completion of study participation
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Sneha Mohan, MBBS principal investigator
Mayo Clinic
Questions about this trial
What is this clinical trial studying?
A study testing Carbohydrate-counting-based prandial rapid-acting insulin dosing and Flexible fixed mealtime rapid-acting insulin dosing based on percentage of meal consumed in people with Diabetes Type 2 on Insulin and Hypoglycemia (Diabetic), run by Mayo Clinic.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 8 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Melissa Wang (507-266-6911, wang.melissa@mayo.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Time With Glucose in Target Range of 100 to 180 mg/dL (time frame: From randomization to hospital discharge, up to 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Sep 2026.