Trial Outcomes & Findings for Associated Factors in Perioperative Hypoglycemia in Patients With Diabetes (NCT NCT00826007)

NCT ID: NCT00826007

Last Updated: 2013-05-27

Results Overview

Blood glucose values \<70 mg/dl

• Recruitment status: COMPLETED
• Target enrollment: 587 participants
• Primary outcome timeframe: perioperative period
• Results posted on: 2013-05-27

Participant Flow

Retrospective review of patients who underwent surgical procedures at our institution from 2003-2009

Retrospective

Participant milestones

Measure	Low Normal Group Patients with diabetes who arrived in preoperative area with blood glucose values of 70-89 mg/dl	Hyperglycemia-treated Group Patients with diabetes who had preoperative blood glucose values \>249 mg/dl and were subsequently treated with insulin
Overall Study STARTED	308	279
Overall Study COMPLETED	308	279
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Associated Factors in Perioperative Hypoglycemia in Patients With Diabetes

Baseline characteristics by cohort

Measure	Low Normal Group n=308 Participants Patients with diabetes who arrived in preoperative area with blood glucose values of 70-89 mg/dl	Hyperglycemia-treated Group n=279 Participants Patients with diabetes who had preoperative blood glucose values \>249 mg/dl and were subsequently treated with insulin	Total n=587 Participants Total of all reporting groups
Age Continuous	61.34 years STANDARD_DEVIATION 14.93 • n=5 Participants	56.34 years STANDARD_DEVIATION 14.18 • n=7 Participants	58.96 years STANDARD_DEVIATION 14.57 • n=5 Participants
Sex: Female, Male Female	142 Participants n=5 Participants	137 Participants n=7 Participants	279 Participants n=5 Participants
Sex: Female, Male Male	166 Participants n=5 Participants	142 Participants n=7 Participants	308 Participants n=5 Participants
Region of Enrollment United States	308 participants n=5 Participants	279 participants n=7 Participants	587 participants n=5 Participants
Diabetes type Type 1 diabetes	37 participants n=5 Participants	47 participants n=7 Participants	84 participants n=5 Participants
Diabetes type Type 2 diabetes	217 participants n=5 Participants	175 participants n=7 Participants	392 participants n=5 Participants
Diabetes type type not documented	54 participants n=5 Participants	57 participants n=7 Participants	111 participants n=5 Participants
Renal disease Renal disease documented	85 participants n=5 Participants	54 participants n=7 Participants	139 participants n=5 Participants
Renal disease Renal disease not documented	223 participants n=5 Participants	225 participants n=7 Participants	448 participants n=5 Participants
Insulin regimen prior to preop arrival Insulin use	266 participants n=5 Participants	240 participants n=7 Participants	506 participants n=5 Participants
Insulin regimen prior to preop arrival No documented insulin use	42 participants n=5 Participants	39 participants n=7 Participants	81 participants n=5 Participants
Beta-blocker medication in regimen Documented Beta blocker use	148 participants n=5 Participants	107 participants n=7 Participants	255 participants n=5 Participants
Beta-blocker medication in regimen No documented beta blocker use	160 participants n=5 Participants	172 participants n=7 Participants	332 participants n=5 Participants

PRIMARY outcome

Timeframe: perioperative period

Blood glucose values <70 mg/dl

Outcome measures

Measure	Low Normal Group n=308 Participants Patients with diabetes who arrived in preoperative area with blood glucose values of 70-89 mg/dl	Hyperglycemia-treated Group n=279 Participants Patients with diabetes who had preoperative blood glucose values \>249 mg/dl and were subsequently treated with insulin
Hypoglycemia Incidence	53 participants	10 participants

Adverse Events

Adverse Events Not Collected

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Tamra Dukatz, CRNA, MSN

William Beaumont Hospital

Phone: 2489924741

Email: tdukatz@beaumont.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place