Type2 Diabetes MellitusNCT03104738
Basal Insulin Strategies Before Surgery
A study testing 25% reduction of basal insulin dose in people with Type2 Diabetes Mellitus, run by Ohio State University.
Trial summary
Many patients with Type 2 Diabetes Mellitus (T2DM) are currently being managed with Basal Insulin (BI). However, there is little evidence to support guidelines on dosing adjustments in the preoperative period. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Type2 Diabetes Mellitus
- What is being tested?
- 25% reduction of basal insulin dose
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 20 Nov 2013to 18 Aug 2016
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Subjects who have volunteered and consented to participation in the study during their outpatient preoperative anesthesia appointment.
- Type II Diabetics taking once-daily evening basal insulin (glargine or detemir)
- Patients that will undergo general anesthesia
- Patients who have been on basal insulin for ≥ 3months
Who cannot join
- Inability to read, comprehend, and sign informed consent
- Patients with Type I Diabetes
- Patients who take short-acting insulin boluses which make up greater than 20% of their total daily insulin dose
- Patients who have been on chronic steroids ≥ 5 mg/dl prednisone daily or equivalent for ≥ 1 month within the past 12 months
- Pregnant patients
- Patients on twice-daily dosing of basal insulin
Show all 10Show fewer
- Patient who take basal insulin in the morning
- Patients with a history of severe hypoglycemia, defined as any event in the previous year requiring assistance of another person to actively administer carbohydrate, glucagons, or other resuscitative actions
- Patients that will undergo cardiac, transplant, or brain surgeries
- Prisoners
About this study
Official title: A Comparison of the Impact of Basal Insulin Dosing Strategies on Next-day Surgery Blood Glucose Control
Many patients with Type 2 Diabetes Mellitus (T2DM) are currently being managed with Basal Insulin (BI). However, there is little evidence to support guidelines on dosing adjustments in the preoperative period. The Society for Ambulatory Anesthesia does not advise a reduction in the dose of BI preoperatively, unless there is a specific history of hypoglycemia. The Endocrine Society suggests a 50% reduction in BI dose the evening before surgery. The authors hypothesized that a 25% reduction in BI dose the evening before surgery will result in better perioperative blood glucose control compared with our institutional 50% decrease.
Read the detailed description
A total of 40 subjects diagnosed with T2DM taking once-daily evening BI, scheduled to undergo elective surgery under general anesthesia will be consented and randomized in a 1:1 ratio to received either 50% or 25% reduction of their regular evening BI dose on the evening before surgery. Blood glucose levels (BGL) will be recorded perioperatively according to institutional guidelines.
- Conditions
- Type2 Diabetes Mellitus
- Being tested
- 25% reduction of basal insulin dose
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
25% reduction of basal insulin doseOther
Subjects will be instructed to reduce their basal insulin dose to 75% instead of our institutional 50%.
Subject must check their own blood sugar before reporting to the hospital for their surgery. If the value is less than 70 or subjects are having symptoms of hypoglycemia, subjects will be instructed to immediately ingest 4-8 oz of fruit juice (without pulp) and call their doctor or the hospital.
| Study group | Role | What they receive |
|---|---|---|
| 50% reduction of basal insulin dose | No intervention | This is the institutional standard of care. The evening before surgery, 20 subjects will reduce their basal insulin dose to 50%. |
| 25% reduction of basal insulin dose | Experimental | The evening before surgery, 20 subjects will reduce their basal insulin dose to 25%. Receives: Other: 25% reduction of basal insulin dose |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pre-operative Fasting Blood Glucose, as Measured by Standardized Point of Care Capillary Blood Glucose (CBG) Device in the Pre-op Holding Area.
Capillary blood glucose before surgery, considering a fasting period up to 8 hours prior fasting blood glucose
Measured: Hospital arrival - Anesthesia start time. The time period did not exceed 4 hours, considering that surgeries were scheduled to be morning cases.
Secondary outcomes (10)
Incidence of Preoperative Hypoglycemia
Capillary blood glucose level <80 mg/dl
Measured: Hospital arrival - Anesthesia start time. The time period did not exceed 4 hours, considering that surgeries were scheduled to be morning cases.
Incidence of Preoperative Hypoglycemia Requiring Ingestion of Juice Prior to Arrival to the Hospital
Capillary blood glucose level <70 mg/dl
Measured: Basal insulin dose administration the evening before surgery - Hospital arrival the morning of the surgery. The time period did not exceed 12 hours, considering a fasting period up to 8 hours and a preoperative period up to 4 hours.
Incidence of Preoperative Hyperglycemia
Capillary blood glucose level >179 mg/dl
Measured: Hospital arrival - Anesthesia start time. The time period did not exceed 4 hours, considering that surgeries were scheduled to be morning cases
Incidence of Intraoperative Hyperglycemia
Capillary or arterial/venous blood glucose level >179 mg/dl
Measured: Anesthesia start time - Anesthesia stop time. The time period did not exceed 10 hours, considering type of surgeries or procedures.
Incidence of Patients Requiring Initiation of Perioperative IV Insulin Drip
Measured: Hospital arrival - 24 hours postoperatively.
Incidence of Hyperglycemia in the Post-anesthesia Care Unit (PACU) to 24 Hours Post-operatively
Capillary or arterial/venous blood glucose level >179 mg/dl
Measured: Anesthesia stop time - 24 hours postoperatively.
Incidence of Symptomatic Hypoglycemia Requiring Treatment in the PACU to 24 Hours Post-operatively
Capillary or arterial/venous blood glucose level <70 mg/dl
Measured: Anesthesia stop time - 24 hours postoperatively.
Incidence of Hypoglycemia in the PACU to 24 Hours Post-operatively
Capillary or arterial/venous blood glucose level <80 mg/dl
Measured: Anesthesia stop time - 24 hours postoperatively.
Incidence of Surgical Delay or Cancellation Due to Hyperglycemia
Measured: Hospital arrival - Surgery start date/time. The time period did not exceed 4 hours, considering that surgeries were scheduled to be morning cases
Mean 24-hour Glucose Postoperatively
Measured: Anesthesia stop time - 24 hours postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2017
- Study start20 Nov 2013
- Primary completion18 Aug 2016
- Study completion18 Aug 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Type2 Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by Ohio State UniversityThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Open-label randomized controlled trial
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ohio State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Barbara Rogers, Ohio State University
- Investigators
- Barbara Rogers, MD, Principal investigator, Ohio State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03104738
- Sponsor's protocol ID
- 2013H0232
- Status last verified
- Sep 2019
- First submitted
- 28 Mar 2017
- Last updated
- 6 Sep 2019
- Results posted
- Yes, on ClinicalTrials.gov
- 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 6 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison of the Impact of Basal Insulin Dosing Strategies on Next-day Surgery Blood Glucose Control
- ClinicalTrials.gov ID
- NCT03104738
- Acronym / sponsor ID
- 2013H0232
- Conditions
- Type2 Diabetes Mellitus
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Ohio State UniversityUniversity, hospital or other
- Study start
- 20 Nov 2013 (actual)
- Primary completion
- 18 Aug 2016 (actual)
- Study completion
- 18 Aug 2016 (actual)
- First posted
- 7 Apr 2017 (actual)
- Results
- Posted 5 Nov 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Many patients with Type 2 Diabetes Mellitus (T2DM) are currently being managed with Basal Insulin (BI). However, there is little evidence to support guidelines on dosing adjustments in the preoperative period. The Society for Ambulatory Anesthesia does not advise a reduction in the dose of BI preoperatively, unless there is a specific history of hypoglycemia. The Endocrine Society suggests a 50% reduction in BI dose the evening before surgery. The authors hypothesized that a 25% reduction in BI dose the evening before surgery will result in better perioperative blood glucose control compared with our institutional 50% decrease.
Detailed description
A total of 40 subjects diagnosed with T2DM taking once-daily evening BI, scheduled to undergo elective surgery under general anesthesia will be consented and randomized in a 1:1 ratio to received either 50% or 25% reduction of their regular evening BI dose on the evening before surgery. Blood glucose levels (BGL) will be recorded perioperatively according to institutional guidelines.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Open-label randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| 50% reduction of basal insulin dose | No intervention | –This is the institutional standard of care. The evening before surgery, 20 subjects will reduce their basal insulin dose to 50%. |
| 25% reduction of basal insulin dose | Experimental | Other: 25% reduction of basal insulin doseThe evening before surgery, 20 subjects will reduce their basal insulin dose to 25%. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Subjects who have volunteered and consented to participation in the study during their outpatient preoperative anesthesia appointment.
- Type II Diabetics taking once-daily evening basal insulin (glargine or detemir)
- Patients that will undergo general anesthesia
- Patients who have been on basal insulin for ≥ 3months
Key exclusion criteria (10 listed)
- Inability to read, comprehend, and sign informed consent
- Patients with Type I Diabetes
- Patients who take short-acting insulin boluses which make up greater than 20% of their total daily insulin dose
- Patients who have been on chronic steroids ≥ 5 mg/dl prednisone daily or equivalent for ≥ 1 month within the past 12 months
- Pregnant patients
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 |
|---|---|---|
| 25% reduction of basal insulin doseSubjects will be instructed to reduce their basal insulin dose to 75% instead of our institutional 50%. Subject must check their own blood sugar before reporting to the hospital for their surgery. If the value is less than 70 or subjects are having symptoms of hypoglycemia, subjects will be instructed to immediately ingest 4-8 oz of fruit juice (without pulp) and call their doctor or the hospital. | Other | 25% reduction of basal insulin dose |
Primary outcome
Pre-operative Fasting Blood Glucose, as Measured by Standardized Point of Care Capillary Blood Glucose (CBG) Device in the Pre-op Holding Area.
Time frame: Hospital arrival - Anesthesia start time. The time period did not exceed 4 hours, considering that surgeries were scheduled to be morning cases.
Capillary blood glucose before surgery, considering a fasting period up to 8 hours prior fasting blood glucose
10 secondary outcomes
Incidence of Preoperative Hypoglycemia
Time frame: Hospital arrival - Anesthesia start time. The time period did not exceed 4 hours, considering that surgeries were scheduled to be morning cases.
Incidence of Preoperative Hypoglycemia Requiring Ingestion of Juice Prior to Arrival to the Hospital
Time frame: Basal insulin dose administration the evening before surgery - Hospital arrival the morning of the surgery. The time period did not exceed 12 hours, considering a fasting period up to 8 hours and a preoperative period up to 4 hours.
Incidence of Preoperative Hyperglycemia
Time frame: Hospital arrival - Anesthesia start time. The time period did not exceed 4 hours, considering that surgeries were scheduled to be morning cases
Incidence of Intraoperative Hyperglycemia
Time frame: Anesthesia start time - Anesthesia stop time. The time period did not exceed 10 hours, considering type of surgeries or procedures.
Incidence of Patients Requiring Initiation of Perioperative IV Insulin Drip
Time frame: Hospital arrival - 24 hours postoperatively.
Incidence of Hyperglycemia in the Post-anesthesia Care Unit (PACU) to 24 Hours Post-operatively
Time frame: Anesthesia stop time - 24 hours postoperatively.
Incidence of Symptomatic Hypoglycemia Requiring Treatment in the PACU to 24 Hours Post-operatively
Time frame: Anesthesia stop time - 24 hours postoperatively.
Incidence of Hypoglycemia in the PACU to 24 Hours Post-operatively
Time frame: Anesthesia stop time - 24 hours postoperatively.
Incidence of Surgical Delay or Cancellation Due to Hyperglycemia
Time frame: Hospital arrival - Surgery start date/time. The time period did not exceed 4 hours, considering that surgeries were scheduled to be morning cases
Mean 24-hour Glucose Postoperatively
Time frame: Anesthesia stop time - 24 hours postoperatively
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Sep 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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. This study is not recruiting at the moment.
Barbara Rogers, MD principal investigator
Ohio State University
Questions about this trial
What is this clinical trial studying?
A study testing 25% reduction of basal insulin dose in people with Type2 Diabetes Mellitus, run by Ohio State University.
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 4 inclusion and 10 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: finished, as of the sponsor's last update on 6 Sep 2019. 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?
Yes. Results are posted in the registry (first posted 5 Nov 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Pre-operative Fasting Blood Glucose, as Measured by Standardized Point of Care Capillary Blood Glucose (CBG) Device in the Pre-op Holding Area. (time frame: Hospital arrival - Anesthesia start time. The time period did not exceed 4 hours, considering that surgeries were scheduled to be morning cases.). 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 6 Sep 2019.