Early Glargine (Lantus) in DKA Management in Children With Type 1 Diabetes

• Status: Completed
• Trial end date: 2021-02-28
• Target enrollment: 0
• Participant gender: All

Summary

A frequent complication in the management of diabetic ketoacidosis (DKA) in children with type 1 diabetes is rebound hyperglycemia (blood glucose over 180 mg/dL) which increases the risk of re-developing DKA and can lengthen the hospital stay. The investigators want to study whether giving the long-acting insulin glargine (Lantus®) early in DKA management (versus after complete resolution of the DKA) helps prevent rebound hyperglycemia and makes the transition to insulin injections easier. Participants will also have the option to wear a continuous glucose monitor (CGM) during the study to help us understand blood glucose control during and after DKA.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University of Colorado, Denver
• Treatments: Insulin Glargine

Criteria

Inclusion Criteria:

1. Age 6-17.9 years at time of enrollment.

2. Known history of type 1 diabetes or presumed new-onset type 1 diabetes.

3. Diagnosis of DKA (serum glucose or fingerstick glucose concentration ≥ 200 mg/dL.

4. Venous pH ≤7.3 and/or serum bicarbonate concentration ≤15 mmol/L.

5. Evidence of ketonemia or ketonuria).

Exclusion Criteria:

1. Participants who present in DKA with conditions that affect neurological function such as:

1. suspected alcohol or drug use,

2. severe head trauma,

3. meningitis, etc., who would not be able to consent/assent for the study.

2. Participants who present in DKA who are showing signs of altered mental status at time of enrollment.

3. Other known complicating illness or poorly-controlled chronic illness that is known to affect blood glucose levels and/or electrolyte balance such as:

1. chronic renal disease (requiring hemodialysis),

2. chronic liver disease (with evidence of current hepatic dysfunction,

3. coagulopathy, and/or chronic hepatitis), or

4. severe chronic lung disease (requiring the use of oral steroids).

4. Use of medications that are known to affect blood glucose levels such as:

1. oral glucocorticoids,

2. Metformin,

3. SGLT2 inhibitors,

4. GLP-1 receptor agonists,

5. DPP-4 inhibitors,

6. thiazolidinediones

7. sulfonylureas, and

8. vasopressors, etc.

5. Participants who have begun DKA treatment prior to being approached for enrollment and have received more than 6 hours of IV insulin therapy.

6. Participants who are known to be pregnant.

7. Participants who have a known diagnosis of type 2 diabetes.

8. Participants for whom the treating physicians feel a specific insulin regimen is necessary such that patient safety or well-being could be compromised by enrollment into the study.