Insulin Degludec for the Management of Patient With Recurrent Diabetic Ketoacidosis
NCT ID: NCT03001323
Last Updated: 2021-05-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
TERMINATED
NA
27 participants
INTERVENTIONAL
2017-01-31
2020-09-25
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
A Trial Comparing the Efficacy of Insulin Degludec With Insulin Glargine on Glycaemic Control Using Continuous Glucose Monitoring in Patients With Type 1 Diabetes
NCT01569841
Comparison of Different Insulin Dosing Algorithms Using Hepatic Directed Vesicle-Insulin Lispro and Insulin Degludec
NCT03938740
Early Administration of Insulin Glargine in Patients With Diabetic Ketoacidosis
NCT06007508
Insulin Degludec and Symptomatic Nocturnal Hypoglycaemia
NCT02192450
A Trial Comparing the Efficacy, Patient-reported Outcomes and Safety of Insulin Degludec 200 U/mL vs Insulin Glargine in Subjects With Type 2 Diabetes Mellitus Requiring High-dose Insulin
NCT01570751
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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:
To determine the difference in rate of recurrent Diabetic Ketoacidosis (DKA) over 6 months and 12 months in participants who have a history of previous DKA and medication adherence between groups treated with degludec vs other long-acting insulins (glargine or detemir).
Secondary outcomes:
BG control (Hba1c during study period) tested q 3 months Discharge long-acting insulin dose compared to admission dose LOS for DKA admission Number of readmissions in one year Number of ER visits Hypoglycemia -self reported, documented by glucometer or ER visit for severe hypoglycemia Adherence to study regimen from phone call information and clinic visits
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.
Study Protocol:
Investigators will obtain informed consent and enroll participants admitted to the Hennepin County Medical Center (HCMC) in this study from Jan 2016 until investigators have adequate enrollment.
Investigators will collect the initial data as following:
1. Age, sex, height, weight, BMI
2. Age at diagnosis of diabetes
3. Number previous DKA admissions in past 2 years, lifetime (even if the admission was to other hospitals)
4. Preadmission insulin dosing - long acting
5. Reason for DKA
6. Alcohol, drug use, homelessness, mental illness
7. Admission labs - HCO3, AG, BOHB, glucose, creatinine
8. Length of stay with each DKA episode( LOS)
The participants will be randomly assign to the intervention or control groups.
Intervention Group:
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. Degludec insulin will be started at study initiation during the hospitalization if the participant is randomized to this arm.
Fast acting insulin that participant 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. Participants will have basal bolus regimen either using carbohydrate counting or with set doses for meals, depending on their ability. Participants will use the fast acting insulin they were on at the time of admission.
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 to check on dose, compliance, hospital admissions, and hypoglycemia. Compliance with medication will be verified verbally.
Clinic visits every 3 months for 1 year with dose adjustment as above. Supply adequate insulin degludec until next visit.
Control Group:
Discharge on 0.3 U/kg of admission long acting insulin glargine or detemir (provided by diabetes and endocrine clinic) regardless of participant's home insulin regimen at the time of admission with reduction to 0.2 U/kg in CKD with GFR \<30 ml/hr. This will be done at the time of study initiation during the hospitalization if the participant is randomized to this arm.
Fast acting insulin adjustment with meals and insulin adjustment for hypoglycemia will be done similarly as in the intervention group. Phone calls every month to check on dose, compliance, hospital admissions, and hypoglycemia. Compliance will be assessed verbally.
Clinic visits every 3 months for 1 year with insulin dose adjustment as above. Supply adequate insulin glargine or detemir until next visit.
Study site: Hennepin County Medical Center (HCMC), Minneapolis, MN.
Data Analysis: Sample size, power calculation and statistical plan
Investigators determined that considering incidence of DKA 100 % (since all patients admitted with DKA would be eligible for screening), moreover, in order to observe 30 % reduction in DKA related hospitalization over 2 years period in intervention group and by keeping power at 80 % with confidence interval (CI) of 0.05, study will need to enroll 21 subjects in each group or 42 total sample size.
In order to mitigate the effects of loss to follow up, noncompliance and protocol deviations, intention to treat (ITT) analysis will be performed on primary and secondary outcome measure for both groups. A separate analysis will be done including those patient who will complete the trial in both groups.
Baseline data of intervention and control group will be compared. In case of significant differences, further analysis will be done to adjust for those differences prior to final analysis.
ITT analysis will be based on in ITT comparison.
Descriptive and inferential statistical methods will be used for analyzing the data using Statistical Analysis software (SAS) 9.4. For continuous variables, mean, median and variance will be reported, while for discrete variables rate, risk ratios, relative risk, rate of occurrence and percentage differences will be reported.
For primary outcome measure, investigators will use χ2 test to assess relationship between the primary outcome and some of the binary nature secondary measures. Stratification will be used for analysis as needed. In that case, chi-square tests for overall and within relevant stratifications will be conducted. To assess the difference between continuous variables (such as hemoglobin A1C, bicarbonate, anion gap, Creatinine etc.), t-test will be used for normally distributed data. Otherwise Mann-Whitney U test will be used. P-values at 95 % CI will be reported. Since it is a superiority trial, we will use one-tail test for significance.
.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
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.
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.
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.
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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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.
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.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
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
\-
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Hennepin Healthcare Research Institute
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Hennepin County Medical Center
Minneapolis, Minnesota, United States
Countries
Review the countries where the study has at least one active or historical site.
Related Links
Access external resources that provide additional context or updates about the study.
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
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
HRS#16-4236
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.