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Diabetes Mellitus, Type 1NCT02548494

Early Administration of Long-acting Insulin Treatment of Diabetic Ketoacidosis in Pediatric Type 1 Diabetes

A study testing Glargine, IV insulin and Electrolyte Correction in people with Diabetes Mellitus, Type 1 and Diabetic Ketoacidosis, run by Chattanooga-Hamilton County Hospital Authority at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

The management goals of diabetic ketoacidosis (DKA) in the pediatric type 1 diabetes (T1DM) population are fluid and electrolyte repletion, insulin administration, and correction of acidosis in order to stabilize the patient. Read more about this study

Who is it for?
Ages 1 year to 21 years
What is being tested?
Glargine, IV insulin and Electrolyte Correction
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
17 participants
Where
1 siteUnited States
Study dates
Nov 2015to 1 Feb 2019
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 1 year to 21 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • T1DM
  • Hyperglycemia >200 mg/dl
  • Bicarbonate ≤ 15 mmol/L
  • pH < 7.3
  • Ketonemia
  • Ketonuria
Show all 9Show fewer
  • Glucosuria
  • Admission to PICU (Pediatric Intensive Care Unit)
  • Ages 1-21 years

Who cannot join

  • Patients who received glargine within the last 24 hours
  • Patients with sepsis

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Children's @ Erlanger

    Chattanooga, Tennessee, 37403

Other trials in United States

About this study

Official title: Early Administration of Long-acting Insulin Glargine for the Treatment of Diabetic Ketoacidosis in Pediatric Type 1 Diabetes: A Randomized Double Blind Trial

The management goals of diabetic ketoacidosis (DKA) in the pediatric type 1 diabetes (T1DM) population are fluid and electrolyte repletion, insulin administration, and correction of acidosis in order to stabilize the patient. Traditionally, a rapid-acting insulin IV infusion is begun immediately and continued until the acidosis is corrected and hyperglycemia normalized. Once the acidosis is corrected, patients are able to be transitioned to a subcutaneous insulin regimen.

The role that a subcutaneous long-acting insulin such as glargine has in the acute treatment of DKA has not been extensively studied. While giving glargine during the treatment of DKA is becoming more common place, few studies have examined the potential risks and benefits of its use. This study will investigate the effects of early administration of glargine during DKA in patients with newly diagnosed TIDM.

The design of this study is a prospective, double-blind study of children ages 2-21 who are admitted to the hospital in DKA with a diagnosis of T1DM. The control group will receive all traditional methods of treatment for DKA, including a placebo subcutaneous injection. The study group will receive the same treatment, but will be supplemented with a subcutaneous glargine injection.

Being tested
Glargine, IV insulin, Electrolyte Correction, Correction of Fluid Loss
Medical subject headings
Diabetes Mellitus, Type 1, Diabetic Ketoacidosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • GlargineDrug

    Also called Lantus

    The control group will receive all traditional methods of treatment for DKA, including a placebo subcutaneous injection. The study group will receive the same treatment, but will be supplemented with a subcutaneous glargine injection.

  • IV insulinDrug

    The intravenous infusion of insulin at a weight-based fixed rate until ketosis has subsided.

  • Electrolyte CorrectionOther

    If the potassium level is greater than 6 mEq/L, do not administer potassium supplement. If the potassium level is 4.5-6 mEq/L, administer 10 mEq/h of potassium chloride. If the potassium level is 3-4.5 mEq/L, administer 20 mEq/h of potassium chloride.

  • Correction of Fluid LossOther

    Initial correction of fluid loss is either by isotonic sodium chloride solution or by lactated Ringer solution. The recommended schedule for restoring fluids is as follows:

    • Administer 1-3 L during the first hour.
    • Administer 1 L during the second hour.
    • Administer 1 L during the following 2 hours
    • Administer 1 L every 4 hours, depending on the degree of dehydration and central venous pressure readings
Study groups in NCT02548494
Study groupRoleWhat they receive
Control GroupPlacebo comparatorThe control group will receive all traditional methods of treatment for DKA including iv insulin, correction of fluid loss, and electrolyte correction, including a placebo subcutaneous injection.
Receives: Drug: IV insulin; Other: Electrolyte Correction; Other: Correction of Fluid Loss
Treatment GroupExperimentalThe study group will receive the same treatment including iv insulin, correction of fluid loss, and electrolyte correction, but will be supplemented with a subcutaneous glargine injection.
Receives: Drug: Glargine; Drug: IV insulin; Other: Electrolyte Correction; Other: Correction of Fluid Loss

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Blood glucose

    Measured: Within 3 hrs of arrival

Secondary outcomes (7)

  1. Blood glucose

    checking for changes in levels after intervention initiation

    Measured: 4 hours after intervention initiation

  2. blood pH

    Measured: within 3 hours of arrival

  3. blood pH

    checking for changes in levels after intervention initiation

    Measured: 4 hours after intervention initiation

  4. blood bicarbonate level

    Measured: Within 3 hrs of arrival

  5. blood bicarbonate level

    checking for changes in levels after intervention initiation

    Measured: 4 hours after intervention initiation

  6. Urinalysis for levels of ketones & glucosuria

    Measured: Within 3 hrs of arrival

  7. Urinalysis for levels of ketones & glucosuria

    checking for changes in levels after intervention initiation

    Measured: 4 hours after intervention initiation

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Sep 2015 (estimated)
  2. Study startNov 2015
  3. Primary completion1 Feb 2019
  4. Study completion1 Feb 2019

Why it stopped: Project terminated due to insufficient resources for recruitment.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
17 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02548494
Sponsor's protocol ID
15-Lantus
Status last verified
Sep 2020
First submitted
9 Sep 2015
Last updated
23 Sep 2020
Results posted
No
Data monitoring committee
No
Individual data sharing
Undecided

Publications

  • Levitsky LL et al. Epidemiology, presentation, and diagnosis of type 1 diabetes mellitus in children and adolescents. In: UpToDate, Wolfsdorf J (Ed), UpToDate, Waltham, MA. (Accessed on November 3, 2014.)

  • Jeha GS, Haymond Mw. Treatment and complications of diabetic ketoacidosis in children. In: UpToDate, Waltham MA. (Accessed on November 4, 2014.)

  • Urakami T, Naito Y, Seino Y. Insulin glargine in pediatric patients with type 1 diabetes in Japan. Pediatr Int. 2014 Dec;56(6):822-828. doi: 10.1111/ped.12379. Epub 2014 Sep 16.

    PubMed 24840321

  • Shankar V, Haque A, Churchwell KB, Russell W. Insulin glargine supplementation during early management phase of diabetic ketoacidosis in children. Intensive Care Med. 2007 Jul;33(7):1173-1178. doi: 10.1007/s00134-007-0674-3. Epub 2007 May 17.

    PubMed 17508198

  • Hsia E, Seggelke S, Gibbs J, Hawkins RM, Cohlmia E, Rasouli N, Wang C, Kam I, Draznin B. Subcutaneous administration of glargine to diabetic patients receiving insulin infusion prevents rebound hyperglycemia. J Clin Endocrinol Metab. 2012 Sep;97(9):3132-7. doi: 10.1210/jc.2012-1244. Epub 2012 Jun 8.

    PubMed 22685233

  • 6Lexicomp online

Questions about this trial

What is this clinical trial studying?

A study testing Glargine, IV insulin and Electrolyte Correction in people with Diabetes Mellitus, Type 1 and Diabetic Ketoacidosis, run by Chattanooga-Hamilton County Hospital Authority at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 23 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was stopped early (reason given: Project terminated due to insufficient resources for recruitment.). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Blood glucose (time frame: Within 3 hrs of arrival). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02548494, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Sep 2020.

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