Insulin Degludec for the Management of Patient With Recurrent Diabetic Ketoacidosis
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 27
- 试验地点
- 1
- 主要终点
- Reduction in frequency of diabetic ketoacidosis
研究概览
简要总结
Given the longer half life of insulin degludec compared to glargine /levemir ,investigators believe that insulin degludec will reduce the rate of recurrent DKA. The investigator will randomize participants to control and intervention group. Control group will receive Lantus/Levemir and intervention group will receive degludec. The investigators will call participants monthly and see them in the clinic every three months.The investigators will follow them for 1 year and evaluate if there will be a difference in rate of DKA in between these two groups.
详细描述
Hypothesis:
Use of a longer-lasting basal insulin (degludec) in patients with recurrent Diabetic Ketoacidosis (DKA) will reduce the rate of recurrent DKA and improve adherence to daily administration in patients who have had 2 or more episode of DKA in the past 2 years.
STUDY DESIGN AND METHODS:
Patients admitted with Diabetic Ketoacidosis (DKA) to Hennepin County Medical Center (HCMC) who have a prior episode of DKA within 2 years will be offered enrollment in a prospective, randomized unblinded trial to determine whether long acting insulin degludec will reduce the rate of recurrent DKA and improve compliance over the period of 1 year when compared with the control group who will stay on their pre-study long acting insulin (glargine or detemir).
Primary Outcomes:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients age >18 year with previous diagnosis of Diabetes Mellitus and previous admission for DKA in any facility within the prior 2 years who meet the criteria for DKA at the time of admission and are willing to participate in the study protocol will be enrolled in the study.
- •DKA is defined as:
- •Serum bicarbonate below 18 mg/dl
- •Anion Gap over greater than or equal to 16
- •Serum ketones or beta hydroxybutyrate elevation > 3 mmol/L
- •Serum glucose greater than or equal to 250 mg/dl
排除标准
- •Patients with no previous DKA, patients who are not willing to consent to participate in the study protocol for 1 year, pregnant women, dementia, and end stage renal disease on dialysis.
研究组 & 干预措施
Degludec
Discharge on once a day degludec insulin by pen (supplied by Novo) at dose 0.3 U/kg with reduction to 0.2 U/kg for GFR <30 ml/hr.
干预措施: Degludec (Drug)
Standard long-acting
Discharge on 0.3 U/kg of admission long acting insulin glargine or detemir (provided by diabetes and endocrine clinic) regardless of their home insulin regimen at the time of admission with reduction to 0.2 U/kg in CKD with GFR <30 ml/hr.
干预措施: Standard long-acting (Drug)
结局指标
主要结局
Reduction in frequency of diabetic ketoacidosis
时间窗: 6 and 12 months
次要结局
- Readmission to the hospital frequency(1 yr)
- Basal insulin requirements(1 yr)
- A1c(Hemoglobin A1c) level Discharge long-acting insulin dose compared to admission dose LOS for DKA admission Number of readmissions in one year Number of ER visits Hypoglycemia(1yr -every 3 months)
- Hypoglycemia frequency and severity(1 yr)
- Emergency room visit reduction for diabetes(1 yr)
- length of stay for Diabetic ketoacidosis(LOS)(1 yr)