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Considerations for Pediatric Patients
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Children have needs that dictate different standards of care. The management of children on insulin also should take differences between various ages into account. This section will provide an overview of some of the considerations for your younger patients. Please be sure to consult the literature for more specific information about the appropriate standards of care for children and adolescents with diabetes.

Glycemic goals for children and adolescents
Goals for glycemic control should be individualized for each patient's needs. Lower goals may be reasonable based on a benefit-risk assessment. If children have frequent episodes of hypoglycemia, higher goals may be necessary.1

American Diabetes Association Plasma Blood Glucose and A1C Goals1
(Type 1 diabetes by age group)


Values by age Blood glucose range (mg/dL) A1C Rationale
  Before meals Bedtime/Overnight    
Toddlers and preschoolers (<6 years) 100-180 110-200 <8.5% (but >7.5%) High risk and vulnerability to hypoglycemia
School age (6 to 12 years) 90-180 100-180 <8% Risks of hypoglycemia and relatively low risk of complications prior to puberty
Adolescents and young adults (13 to 19 years) 90-130 90-150 <7.5% Risk of hypoglycemia and psychological issues
Adapted from Silverstein J, et al. Diabetes Care. 2005;28(1):186-212.
Humalog is for use in children 3 years of age and older.


Postprandial blood glucose values should be measured when there is disparity between blood glucose values before meals and A1C levels.

Hypoglycemic unawareness in children
Because children and adolescents are growing and developing, there are unique considerations when starting insulin based on their motor development, cognitive abilities, and emotional maturity. One issue related to cognitive development is hypoglycemic unawareness, which is an inability to feel or recognize the symptoms of low blood glucose. Children may not understand what is happening to their body during a hypoglycemic episode, nor may they be able to verbally express themselves if very young. You may need to adjust their glycemic goals accordingly.1 Parents should be advised to check their child's blood glucose frequently to catch any unrecognized episodes of hypoglycemia.

The "honeymoon" phase when starting children on insulin
It is common for a newly diagnosed type 1 child's diabetes to enter a honeymoon phase. This is a phase when the pancreas recovers some of its ability to produce insulin, usually within several weeks after initiating insulin therapy. During this honeymoon phase, the child's insulin requirements may decrease. Meanwhile, beta-cell destruction within the pancreas continues, and the need for exogenous insulin increases with this progressive loss.1 Work closely with the child's parents during the initial start to watch for, and treat, this phenomenon.

Diabetes care in school or the daycare setting
Another issue unique to younger children is diabetes management in a school or daycare setting. An individualized diabetes medical management plan (DMMP) should be developed by the parent/guardian and the child's healthcare team. This includes assuring that an adequate number of school personnel are appropriately trained in checking blood glucose and administering insulin. School personnel should also be familiar with giving Glucagon in an emergency.2 See the Resources section for website links to organizations that can provide guidance on developing a DMMP.

Issues unique to adolescents
It is a cruel irony that diabetes can become more difficult to manage just as teenagers are trying to assert their independence. The same hormones that cause puberty can make blood glucose levels unpredictable. Often, these hormones can cause insulin resistance, thereby increasing the adolescent's insulin requirements.1 It's important there is a good partnership between the healthcare provider, parents, and teenager to address changing needs during this time. This partnership also may be put to the test as adolescents rebel and favor acceptance by their peers over adherence to their diabetes management. Nonetheless, they gradually should be assuming greater responsibility for their self-care despite this psychosocial challenge. Talking honestly about their feelings will be critical in helping make the transition to adult self-care successful.

The considerations outlined in this section are just a few of the many considerations for pediatric patients. See the Resources section for links to more information on the care of pediatric patients on insulin.

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References:
1. Silverstein J, Klingensmith G, Copeland K, et al. Care of children and adolescents with type 1 diabetes: a statement of the American Diabetes Association. Diabetes Care. 2005;28(1):186-212.
2. American Diabetes Association. Standard of medical care in diabetes — 2006. Diabetes Care. 2006;29 Suppl 1:S4-42.


Important Safety Information
Humalog insulins are contraindicated during episodes of hypoglycemia and in patients sensitive to Humalog or one of its excipients. The safety and effectiveness of Humalog in patients less than 3 years of age have not been established. Safety and effectiveness of Humalog Mix75/25 and Humalog Mix50/50 in patients less than 18 years of age have not been established. There are no adequate and well-controlled clinical studies of the use of Humalog in pregnant or nursing mothers.

Potential side effects associated with the use of all insulins include hypoglycemia, weight gain, hypokalemia, lipodystrophy, and hypersensitivity. Because of the difference in action of Humalog, care should be taken in patients in whom these conditions may be clinically relevant (e.g., those who are fasting, have autonomic neuropathy or renal impairment, are using potassium-lowering drugs, or taking drugs sensitive to serum potassium level). Patients should be advised not to mix Humalog Mix75/25 or Humalog Mix50/50 with another insulin. Starting or changing insulin therapy should be done cautiously and only under medical supervision.

When used in an external insulin pump, Humalog should not be diluted or mixed with any other insulin. Humalog Mix75/25 and Humalog Mix50/50 are not indicated for use in external insulin pumps.

Humalog differs from regular human insulin by its rapid onset of action, as well as a shorter duration of activity. Therefore, Humalog and Humalog Mixtures should be given within 15 minutes before a meal. Humalog can also be given immediately after a meal. The short duration of action of Humalog means that patients such as those with type 1 diabetes, whose basal insulin levels are inadequate, will also require a longer-acting insulin to give optimal glucose control (except when using an insulin pump).

Clinical studies comparing Humalog Mix75/25 with human insulin mixtures did not show a difference in the overall rate of hypoglycemia between the two treatments. The overall rate of hypoglycemia did not differ between type 1 and type 2 patients treated with Humalog, as compared with regular human insulin. The lower rate of hypoglycemia with Humalog may be related to higher nocturnal blood glucose levels, as reflected by a small increase in the mean fasting blood glucose levels.

The clinical significance of improvement in postmeal hyperglycemia has not been established. In 12-month clinical studies, A1C did not differ between patients treated with regular human insulin and those treated with Humalog.

Humalog, Humalog Mix75/25, and Humalog Mix50/50 are available by prescription only.

For other important safety information and prescribing considerations, please see Humalog, Humalog Mix75/25, and Humalog Mix50/50 Prescribing Information.

Humalog is a registered trademark of Eli Lilly and Company. Humalog Mix75/25 and Humalog Mix50/50 are trademarks of Eli Lilly and Company.

Humalog Prescribing Information | Humalog Mix75/25 Prescribing Information | Humalog Mix50/50 Prescribing Information | Important Safety Information