Insulin Degludec for the Management of Patient With Recurrent Diabetic Ketoacidosis

NCT03001323 | Terminated

• 1 other identifier: HRS#16-4236
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

• Reduction in frequency of diabetic ketoacidosis

  6 and 12 months

Secondary Outcomes (6)

• 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

• length of stay for Diabetic ketoacidosis(LOS)

  1 yr

• Emergency room visit reduction for diabetes

  1 yr

• Readmission to the hospital frequency

  1 yr

Study Arms (2)

Degludec

EXPERIMENTAL

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

Standard long-acting

ACTIVE COMPARATOR

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

Interventions

Degludec DRUG

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.

Degludec

Standard long-acting DRUG

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.

Standard long-acting

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hennepin Healthcare Research Institute: lead

Study Sites (1)

Hennepin County Medical Center

Minneapolis, Minnesota, 55415, United States

Location

Related Links

• Risk related with DKA - mortality related to DKA
• Hyperglycemic crisis
• Analysis of socioeconomic and psychological factors to analyze factors leading to insulin non compliance.
• To identify the factors that influence recurrent (one or more previous episodes) diabetic ketoacidosis (DKA), which we refer to as recurrent DKA.
• Degludec pharmacology
• Safety and efficacy of degludec

MeSH Terms

Conditions

Diabetes Mellitus

Interventions

insulin degludec

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 14, 2016
• First Posted: December 23, 2016
• Study Start: January 1, 2017
• Primary Completion: January 20, 2019
• Study Completion: September 25, 2020
• Last Updated: May 17, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)