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Type 1 DiabetesPhase 4NCT01971047

Safety and Efficacy Study of Correcting Hyperglycemia in Patients With Diabetes Having Out-patient Surgery

A Phase 4 study testing Regular Insulin and Humalog in people with Type 1 Diabetes and Type 2 Diabetes, run by Emory University at 1 site in United States.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

The purpose of this study is to compare the safety and efficacy of intravenous (IV) administration of FDA approved regular human insulin and subcutaneous (SC) administration of humalog, a rapid-acting insulin analog (a synthetic insulin), for correction of hyperglycemia (high blood sugar) during the immediate… Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Type 1 Diabetes, Type 2 Diabetes
What is being tested?
Regular Insulin and Humalog
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
1 siteUnited States
Study dates
Oct 2013to Sep 2018
Phase
Phase 4
Are there results?
None posted in the registry

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 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Male or female patients between the ages of 18 and 80 years with type 1 and type 2 diabetes
  • patients undergoing ambulatory surgery
  • a known history of diabetes for > 3 months treated with diet, oral antidiabetic agents and/or insulin therapy
  • subjects with an admission/randomization Blood glucose> 180 and < 400 mg/dl
  • Patients willing and able to provide informed consent

Who cannot join

  • Age < 18 or > 80
  • Subjects with increased blood glucose concentration, but without a history of diabetes (stress hyperglycemia)
  • Patients on an insulin pump
  • Patients with a history of clinically significant hepatic disease (cirrhosis, jaundice, end-stage liver disease, portal hypertension) and end- stage renal disease
  • Current or recent (within 3 months) treatment with oral or injectable corticosteroid, parenteral nutrition and immunosuppressive treatment
  • Mental condition rendering the subject unable to understand the nature, scope and possible consequences of the study
  • Female subjects whom are pregnant or breast-feeding at time of qualifying outpatient procedure

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Emory Healthcare Ambulatory Surgical Center

    Atlanta, Georgia, 30322

Other trials in United States

About this study

Official title: The Safety and Efficacy of Correcting Preoperative Hyperglycemia in Ambulatory Surgical Patients With Diabetes: A Randomized Controlled Clinical Trial

The purpose of this study is to compare the safety and efficacy of intravenous (IV) administration of FDA approved regular human insulin and subcutaneous (SC) administration of humalog, a rapid-acting insulin analog (a synthetic insulin), for correction of hyperglycemia (high blood sugar) during the immediate preoperative period in patients with diabetes having outpatient surgery at the Emory Ambulatory Surgical Center (ASC).

In this randomized controlled clinical trial patients with diabetes will be administered corrective doses of IV regular insulin or SC humalog for preoperative hyperglycemia to determine whether SC humalog results in improved intra and post-operative blood sugar control.The most common current practice at Emory University in the ambulatory surgical setting is IV administration of regular insulin for treatment of pre-operative hyperglycemia. Subjects will not be paid for their participation and will be assured of treatment for their hyperglycemia regardless of study participation.

Read the detailed description

Investigators plan to randomize a total of 200 male and female subjects with type 1 and type 2 diabetes,having an out patient surgical procedure, meeting inclusion criteria to receive corrective doses of IV regular insulin (Group I) or SC humalog insulin (Group II). The dosing formula is per Emory University Outpatient Surgical Center protocol for treating hyperglycemia and is the same for both groups. All patients with diabetes will undergo a blood sugar measurement upon arrival to the ASC using the Accuchek blood glucose meter. An admission blood sugar of >180 in a patient with diabetes qualifies the patient for study screening. Subjects will be approached after confirmation of eligibility for the study. Randomization, then treatment, will occur immediately following written informed consent. Demographic data will be recorded.A medical history with detailed history of diabetes will be obtained and surgical and anesthesia details and length of stay recorded. Blood sugar levels will be checked hourly until the patient is ready for discharge. Subsequent treatment will follow the hyperglycemia protocol. All blood sugar results and doses of insulin will be recorded. The subject's participation will end at the time of discharge from the Ambulatory Surgical Center.

Being tested
Regular Insulin, Humalog
Keywords
Diabetes, Surgery, anesthesiology, endocrinology
Medical subject headings
Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2, Diabetes Mellitus

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Regular InsulinDrug

    Also called Novolin

    Group 1 Treatment Arm,Follow dosing for BG >180 per the following formula:

    1. Patients with Type 2 Diabetes to receive dosage based on the formula: (BG-120)/30= # units of insulin
    2. Patients with Type 1 Diabetes to receive dosage based on the formula: (BG-120)/40=# units of insulin
    3. Patients with Type 1 Diabetes and Type 2 Diabetes over the age of 70 or with chronic kidney disease to receive dosage based on the formula: (BG-120)/50=# units of insulin
    4. Consider repeating dose if BG>240 mg/dl after 2 hours of initial dose

  • HumalogDrug

    Also called Lispro

    Group 2 treatment arm. Follow dosing for Blood glucose > 180, per the following formula:

    1. Patients with Type 2 Diabetes to receive dosage based on the formula: (BG-120)/30= # units of insulin
    2. Patients with Type 1 Diabetes to receive dosage based on the formula: (BG-120)/40=# units of insulin
    3. Patients with Type 1 Diabetes and Type 2 Diabetes over the age of 70 or with chronic kidney disease to receive dosage based on the formula: (BG-120)/50=# units of insulin
    4. Consider repeating dose if BG>240 mg/dl after 2 hours of initial dose
Study groups in NCT01971047
Study groupRoleWhat they receive
Group 1-Regular InsulinActive comparatorIntravenous Regular Insulin will be administered for a preoperative Blood glucose of greater than 180.
Receives: Drug: Regular Insulin
Group 2-HumalogActive comparatorSubcutaneous Humalog will be administered for a preoperative Blood glucose of greater than 180
Receives: Drug: Humalog

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. BG concentration differences at 1 and 2 hours post intervention and post operatively

    Compare the difference in Blood glucose concentration at one and two hours after the administration of corrective doses of regular and humalog insulin and immediately following ambulatory surgery.

    Measured: one and two hours post intervention, post operative period

Secondary outcomes (6)

  1. Number and percentage of target BG readings

    Investigators will determine the number and percentage of patients in each group with BG readings within the target range ( 80-180 mg/dl)

    Measured: From time of treatment until patient discharge (an average of three hours, less than one day)

  2. Episodes of hypoglycemia

    Investigators will assess if there is any difference in the number of hypoglycemic events between the two treatment groups and further assess the rate and frequency of hypoglycemia (<70 mg/dl) and severe hypoglycemia (<40 mg/dl).

    Measured: time of intervention to time of patient discharge (an average of three hours, less than one day)

  3. Episodes of hyperglycemia

    Investigators will calculate the number of patients and percent of BG readings with hyperglycemia (>180 mg/dl) and severe hyperglycemia (>300 mg/dl)in each group.

    Measured: time of treatment to time of patient discharge (an average of three hours, less than one day)

  4. Total dose of insulin

    Calculate total dosage of insulin administered to each patient

    Measured: time of intervention to time of patient discharge (an average of three hours, less than one day)

  5. Change in glucose concentration from baseline to one, two and three hours post treatment

    Change in glucose concentration from baseline (prior to insulin administration) to one hour, two hours and three hours (if patient present) after insulin administration

    Measured: time of baseline BG to time of last BG measurement (prior to discharge, less than one day)

  6. Number of perioperative complications

    Investigators will record the number of perioperative complications (cardiovascular, respiratory or other medical complications) or need for hospital admission

    Measured: start of surgery to time of patient discharge (less than one day)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Oct 2013 (estimated)
  2. Study startOct 2013
  3. Primary completionSep 2018 (estimated)
  4. Study completionSep 2018 (estimated)

Resources

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 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01971047
Sponsor's protocol ID
IRB00067662
Status last verified
Mar 2017
First submitted
26 Sep 2013
Last updated
15 Mar 2017
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Regular Insulin and Humalog in people with Type 1 Diabetes and Type 2 Diabetes, run by Emory University at 1 site in United States.

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 5 inclusion and 7 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: withdrawn, as of the sponsor's last update on 15 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

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.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

BG concentration differences at 1 and 2 hours post intervention and post operatively (time frame: one and two hours post intervention, post operative period). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01971047.

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 15 Mar 2017.

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