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Insulin Degludec for the Management of Patient With Recurrent Diabetic Ketoacidosis

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ClinicalTrials.gov Identifier: NCT03001323
Recruitment Status : Recruiting
First Posted : December 23, 2016
Last Update Posted : August 23, 2018
Sponsor:
Information provided by (Responsible Party):
Minneapolis Medical Research Foundation

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus Drug: Degludec Drug: Standard long-acting Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 42 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Insulin Degludec for the Management of Patient With Recurrent Diabetic Ketoacidosis
Actual Study Start Date : January 2017
Estimated Primary Completion Date : January 2019
Estimated Study Completion Date : January 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 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.
Drug: 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.

Fast acting insulin that patient is using will be adjusted so that total daily dose given to cover 2 or 3 meals is equal to the long-acting insulin dose. Patient will have basal bolus regimen either using carb counting or with set doses for meals.

Insulin adjustment if hypoglycemia (less than 60 mg/dl) or if fasting BG over 140 despite insulin compliance. For hypoglycemia, dose will be lowered 0.05 U/kg and for elevated fasting glucose it will be raised 0.05 U/kg.

Phone calls every month and clinic visits every 3 months for 1 year with dose adjustment as above.


Active Comparator: 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.
Drug: Standard long-acting

Discharge on once a day long-acting insulin by pen that patient is using at time of enrollment (supplied by clinic) at dose 0.3 U/kg with reduction to 0.2 U/kg for GFR <30 ml/hr.

Fast acting insulin that patient is using will be adjusted so that total daily dose given to cover 2 or 3 meals is equal to the long-acting insulin dose. Patient will have basal bolus regimen either using carb counting or with set doses for meals.

Insulin adjustment if hypoglycemia (less than 60 mg/dl) or if fasting BG over 140 despite insulin compliance. For hypoglycemia, dose will be lowered 0.05 U/kg and for elevated fasting glucose it will be raised 0.05 U/kg.

Phone calls every month and clinic visits every 3 months for 1 year with dose adjustment as above.





Primary Outcome Measures :
  1. Reduction in frequency of diabetic ketoacidosis [ Time Frame: 6 and 12 months ]

Secondary Outcome Measures :
  1. 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 [ Time Frame: 1yr -every 3 months ]
  2. Hypoglycemia frequency and severity [ Time Frame: 1 yr ]
  3. length of stay for Diabetic ketoacidosis(LOS) [ Time Frame: 1 yr ]
  4. Emergency room visit reduction for diabetes [ Time Frame: 1 yr ]
  5. Readmission to the hospital frequency [ Time Frame: 1 yr ]
  6. Basal insulin requirements [ Time Frame: 1 yr ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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:

  1. Serum bicarbonate below 18 mg/dl
  2. Anion Gap over greater than or equal to 16
  3. Serum ketones or beta hydroxybutyrate elevation > 3 mmol/L
  4. Serum glucose greater than or equal to 250 mg/dl

Exclusion Criteria:

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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03001323


Contacts
Contact: Lisa Fish, MD 612-873-8760 Lisa.Fish@hcmed.org

Locations
United States, Minnesota
Hennepin County Medical Center Recruiting
Minneapolis, Minnesota, United States, 55415
Contact: Lisa Fish, MD    612-873-8760    Lisa.Fish@hcmed.org   
Sponsors and Collaborators
Minneapolis Medical Research Foundation

Additional Information:
Responsible Party: Minneapolis Medical Research Foundation
ClinicalTrials.gov Identifier: NCT03001323     History of Changes
Other Study ID Numbers: HRS#16-4236
First Posted: December 23, 2016    Key Record Dates
Last Update Posted: August 23, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Diabetic Ketoacidosis
Diabetes Mellitus
Ketosis
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Acidosis
Acid-Base Imbalance
Diabetes Complications
Insulin, Globin Zinc
Insulin
Insulin, Long-Acting
Hypoglycemic Agents
Physiological Effects of Drugs