type i diabetes: adult case study presented by: sarah devries, jamie hillman, mary ann hudson, and...

Type I Diabetes: Adult Case Study

Presented by:Sarah Devries, Jamie Hillman, Mary

Ann Hudson, and Heather UsherThe Ohio State College of Nursing

August 2, 2010

Client Chief Complaint and Past Medical History

45-year-old caucasian female with chief complaints of fatigue, weight-loss of 20 pounds in one month, extreme thirst, and frequent urination. Patient has changed eyeglass prescription twice in six months.

Patient has abandoned near-daily aerobic exercise due to fatigue, denies anorexia, dysuria, abnormal stress, recreational drug use, ETOH abuse, smoking, prior hospitalizations, allergies,or chronic disease.

Client Social and Family History

Client lives with husband of 21 years and two children aged 16 and 17. Husband is employed as high school teacher, client is 22 year employee of a company as an accountant. Client states family life is busy and enjoyable. Client denies abnormal social or familial stressors.

Client’s mother is alive with not significant medical history. Father is alive and diagnosed with hypertension managed well with ACEi. Grandparents deceased. Only grandparent history is that paternal grandfather died of MI at 62.

Client Physical Exam

Ht: 5’7” Wt: 130 lbsVS: 128/78, 72, 20

All physical findings in head to toe exam, including cranial nerve exam, are within normal limits.

Client Diagnostic Laboratory Results and Diagnosis

Fasting Blood Glucose: 250HbA1c: 9

Ketones: Negative

Diagnosis is Type I Diabetes Mellitus

Diagnosis Criteria for Type I Diabetes Mellitus

Diagnostic Criteria Symptoms of diabetes (polyuria, polydipsia, unexplained weight loss)

Plus casual plasma glucose concentration ≥200 mg/dL or Fasting plasma glucose concentration ≥126 mg/dL or 2-hour postchallenge glucose concentration ≥200 mg/dL during a 75-g oral glucose tolerance test

One of the 3 criteria listed is sufficient to establish the diagnosis of diabetes mellitus. These assessments should be confirmed by repeated testing on a subsequent day in the absence of unequivocal hyperglycemia. 1

Brief Pathophysiological Review of Type I Diabetes

MellitusType 1 Diabetes Mellitus Accounts for only 5% to 10% of

all diabetes mellitus cases. Caused by an absolute deficiency of insulin secretion due to a cellular-mediated autoimmune destruction of the pancreatic β-cells. Viruses associated with initiation of β-cell destruction include congenital rubella, coxsackievirus B, cytomegalovirus, adenovirus, and mumps. Rate of β-cell destruction varies. Infants and children often experience rapid β-cell destruction; rate of destruction is usually slower in adults. Individuals at increased risk can often be identified by serological evidence of an autoimmune pathologic process occurring in the pancreatic islet cells and by

genetic markers. 2

Treatment and Therapeutic Objectives Guidelines Established by American Academy of Clinical

Endocrinologists Academy partners with American Diabetes

Association for Patient Information and Education

Therapeutic Objectives of Client Treatment Plan

Encourage patients to achieve glycemic levels as near normal as possible without inducing clinically significant hypoglycemia (grade A AACE Guideline); glycemic targets include:

• HbA1c ≤6.5%• Fasting plasma glucose concentration <110

mg/dL• 2-hour postprandial glucose concentration

<140 mg/dL 3

Therapeutic Objectives of Client Treatment Plan

Refer patient for comprehensive, ongoing education in diabetes self-management skills and nutrition therapy (grade A AACE Guideline); education should:

Be provided by a qualified health care professionalFocus on all aspects of diabetes self- management

relevant to each patient treatment planPromote behavioral changes to support effective and

consistent application of the prescribed diabetes treatment plan and an overall healthy lifestyle

Be continued as an ongoing intervention to accommodate changes in the treatment plan and patient status

Initiate self-monitoring of blood glucose levels 4

Specific Therapeutic Objectives for Treatment of DM

I Patient1. Obtain baseline glycemic profile

including HbA1c, fasting BG, pre/postprandial BG for 7 days

2. After initiation of Rx therapy, monitor and titrate patient for 2-3 months until ideal glycemic profile is achieved

3. If glycemic goals are NOT achieved, intiate more intense therapy and monitor and titrate patient for another 2-3 months until ideal glycemic profile is achieved.

Specific Therapeutic Objectives for Treatment of DM

I Patient4. Instruct patient to always check BG before injection

of insulin or before insulin pump adjustment5. Instruct patient if meeting BG target check BG

4x/day. If NOT meeting BG target, check BG pre/postprandial, 2 hours postprandial, and 2 or 3 a.m. spot checks

6. Instruct patient to check BG with suspected hypoglycemia, when at risk for hypoglycemia, or before driving

7. Instruct patient to check BG more frequently during illness or intense exercise

8. Instruct patient to check ketones after a BG reading of 250 mg/dL or above.

9. Instruct patient to recognize the signs and symptoms of hypoglycemia and how to treat it 5

DCCT Trial--Clinical Guidelines

Diabetes control and Complications Trial Study with 29 medical centers and 1400 patients with Type 1

between the ages of 13 and 39 with diabetes for at least one year. Study ran from 1983-1993

Objectives: to compare the effect of standard diabetes therapy to intensive diabetes therapy and to determine if type of insulin therapy had an effect on preventing complications from diabetes.

Findings:Patients in the intensive insulin therapy group had 76% reduced risk of retinopathy, 50% reduced risk of nephropathy, 60% reduced risk of neuropathy, 57% reduction in nonfatal heart attacks, strokes, and heart disease, 35% reduction in LDL, and an average HgbA1C of 7.2%

Findings were so significant, the study ended 2 years early Recommendations:Check BG 4 times daily. Administer at least 4

injections of rapid-acting insulin daily or bolus at least 4 times with pump therapy. Adjust insulin doses for food and exercise. Keep scheduled appointments with health care team.

Team Approach for Therapeutic Objectives for Treatment of DM

I Managing diabetes mellitus

requires a team approach to patient care. However, because diabetes is primarily a self-managed disease, education in self-management skills is essential in implementing interventions. Initial and ongoing self-management education must be made available to all patients with diabetes mellitus. Self-management education improves HbA1c levels, and increased contact time with educators enhances the positive effect.6

Drug Classes Used to Treat Type I DiabetesDrug Classes Used to Treat Type I Diabetes

Therapeutic Class - Antidiabetics

Efficacy Safety Suitability

Pancreatics Indications: For use in patients with diabetes mellitus to help lower circulating blood glucose levels.

Pharmacodynamics: Lowers circulating blood glucose via increasing glucose uptake into cells. Promotes conversion of glucose to glycogen; also promotes conversion of amino acids into protein (in muscles). Increases triglyceride formation. Decreases release of free fatty acids. Pharmacokinetics: Absorption: Dependent upon type of insulin rapidly absorbed to delayed absorption. Systemic absorption. Distribution: Widely distributed. Metabolism: Hepatic, renal, splenic, and muscular metabolism. Excretion: Hepatic, renal, splenic, and m uscular metabolism. Duration of Action: Dependent upon the type of insulin used; rapid acting to long acting.

Side Effects: - Endocrine: hypoglycemia. - Local: lipodystrophy,

erythema, edema, pruritis. - Miscellaneous:

allergic/anaphyl - atic reaction.

Interact ions: - Beta - blockers, clondine,

reserpine may mask symptoms of hypoglycemia.

- Corticosteroids, thyroid supplements, estrogens can increase insulin requirements.

- Alcohol, ACE inhibitors, MAO inhibitors, oral hypoglycemics, salicylates may decrease insulin req uirements.

- Glucosamine may worsen blood glucose control.

- Coenzyme Q - 10 can cause additional hypoglycemic effects.

Cautions: - Stress, infection, or dietary

changes can alter requirements of pancreatics.

Contraindicated: - Hypoglycemia. - Severe hepatic, rena l, or

thyroid dysfunction. - Other endocrine dysfunction. Pregnancy: Can be safely used in pregnancy.

Hormones Indications: With mealtime insulin, used to control circulating blood glucose in those who cannot control their circulating blood glucose with insulin alone.

Pharmacodynamics: Synthetic analogue helps control postprandial hyperglycemia. Pharmacokinetics: Absorption: Systemic absorption (30 to 40%) Distribution: Bound to

Side Effects: - Endocrine: hypoglycemia. - Injection site reaction,

systemic allergic reaction. - Gastrointestinal: nausea,

vomiting, anorexia, abdominal pain.

- Central Nervous System: dizziness, fatigue, headache.

- Respi ratory: cough.

Interactions: - Hypoglycemia when used with

other insulins. - Decreased gastric motility

with anticholinergics and atropine.

Cautions: - Lactation. Contraindicated:

Pancreatics--Rapid ActingDrug Name Efficacy Dose Safety Suitability Insulin Aspart - Novolog Indications: Controlling hyperglycemia in type 1 and type 2 diabetes mellitus.

Pharmacodynamics: Decreases circulating blood glucose through stimulating glucose intake in skeletal muscle and fat; inhibits hepatic glucose production. Pharmacokinetics: Absorption: Rapid acting from subcutaneous injection via systemic absorption. Distribution: Widely distributed. Metabolism: Hepatic, renal, splenic, and muscular metabolism. Excretion: Hepatic , renal, splenic, and muscular metabolism. Half - life: 60 to 90 minutes. Onset: 0.17 to 0.33 hours Peak: 1 to 3 hours. Duration: 3 to 5 hours.

Route: Subcutaneous injection - Given

with 5 to 10 minutes before a meal based on individual patient needs. Usual total dose per day is 0.5 to 1 unit/kg/day.

Side Effects: - Endocrine:

hypoglycemia. - Local:

lipodystrophy, erythema, edema, pruritis.

- Miscellaneous: allergic/anaphyl- atic reaction.

Drug Interactions: - Beta - blockers,

clondine, reserpine may mask symptoms of hypoglycemia.


- Alcohol, ACE inhibitors, MAO inhibitors, oral hypoglycemics, salicylates may decrease insulin requirements.


- Coenz yme Q- 10 can cause additional hypoglycemic effects.

Contraindications: - Hypoglycemia. - Allergy/hypersensitivity

to insulin aspart. Cautions: - Stress and infection

(increase insulin requirements).

- Renal and hepatic impairment (decrease insulin requirements).

Pregnancy Category: Category B

Pancreatics--Rapid ActingInsulin Lispro - Humalog Indications: Controlling hyperglycemia in type 1 and type 2 diabetes mellitus.

Pharmacodynamics: Decreases circulating blood glucose through stimulating glucose intake in skeletal muscle and fat; inhibits hepatic glucose production. Pharmacokinetics: Absorption: Rapid acting from subcutaneous injection via systemic absorption. Distribution: Widely distributed. Metabolism: Hepatic, renal, splenic, and muscular metabolism. Excretion: Hepatic, renal, splenic, and muscular metabolism. Half - life: 1 hour. Onset: within 15 minutes. Peak: 1 to 1.5 hours. Duration: 6 - 8 hours.

Route: Subcutaneous injection - Dependent

upon blood glucose, personal response to drug. Usual maintenance dose per day is 0.5 to 1.2 unit/kg/day.

Side Effects: - Endocri ne:










Contraindicat ions: - Hypoglycemia. - Allergy/hypersensitivity

to insulin lispro. Cautions: - Stress and infection




Pancreatics--Rapid ActingInsulin Glulisine - Apidra Indications: Controlling hyperglycemia in type 1 and type 2 diabetes mellitus.

Pharmacodynamics: Decreases circulating blood glucose through stimulating glucose intake in skeletal muscle and fat; inhibits hepatic glucose producti on. Pharmacokinetics: Absorption: Rapid acting from subcutaneous injection via systemic absorption. Distribution: Widely distributed. Metabolism: Hepatic, renal, splenic, and muscular metabolism. Excretion: Hepatic, renal, splenic, and muscular metabolism . Half - life: 42 minutes. Onset: within 15 minutes. Peak: 1 hour. Duration: 2 - 4 hours.

Route: Subcutaneous injection, intravenous infusion - Dependent

upon blood glucose, personal response to drug, exercise level. Administer 15 minutes prior to a meal or within 20 minutes after beginning a meal.

- Can be given through an external infusion device.





Drug Interactions: - Beta - bloc kers,




- Gluc osamine may worsen blood glucose control.



to insulin glulisine. Cautions: - Stress and infection


- Renal and h epatic impairment (decrease insulin requirements).

Pregnancy Category: Category C

Pancreatics--Short ActingDrug Name Efficacy Dose Safety Suitability Cost of

Treatment Regular Insulin - Humulin R - Novolin R Indications: Controlling hyperglycemia in type 1 and type 2 diabetes mellitus.

Pharmacodynamics: Decreases circulating blood glucose through stimulating glu cose intake in skeletal muscle and fat; inhibits hepatic glucose production. Pharmacokinetics: Absorption: Rapid acting from subcutaneous injection via systemic absorption. Distribution: Widely distributed. Metabolism: Hepatic, renal, splenic, and muscula r metabolism. Excretion: Hepatic, renal, splenic, and muscular metabolism. Half - life: 30 to 60 minutes. Onset: 30 to 60 minutes. Peak: 2 to 4 hours. Duration: 5 to 7 hours.

Route: Subcutaneous injection - Usual

total dose per day is 0.5 to 1 unit/kg/day in divided doses.







- Corticosteroids , thyroid supplements, estrogens can increase insulin requirements.




Contraindications: - Hypoglycemia. - Allergy/hypersensi -

tivity to insulin, preservatives, or additives.

Cautions: - Stress and

infection (increase insulin requirements).


Preg nancy Category: Category B

- Humulin R (100 units): 53.49 -vial

Pancreatics--Intermediate Acting

Drug Name Efficacy Dose Safety Suitability Cost of Treatment

ccvbbNPH Insulin - Humulin N - Novolin N Indications: Controlling hyperglycemia in type 1 and type 2 diabetes mellitus.

Pharmacodynamics: Decreases circulating blood glucose through stimulating glu cose intake in skeletal muscle and fat; inhibits hepatic glucose production. Pharmacokinetics: Absorption: Rapid acting from subcutaneous injection via systemic absorption. Distribution: Widely distributed. Metabolism: Hepatic, renal, splenic, and muscul ar metabolism. Excretion: Hepatic, renal, splenic, and muscular metabolism. Half - life: Unknown. Onset: 1 to 2 hours Peak: 4 to 12 hours. Duration: 18 to 24 hours.

Route: Subcutaneous injection - Dose

dependent upon blood glucose, personal response to drug . Usual total dose per day is 0.5 to 1 unit/kg/day total.












to insulin, preservatives, or additives.

Cautions: - Stress and infection


- Renal and hepatic impairme nt (decrease insulin requirements).


Vials: - 10mL:

$42.99.

Pens: - 3mL:

$124.90 for 5 pens.

Pancreatics--Long ActingDrug Name Efficacy Dose Safety Suitability Cost of

Treatment Insulin Detemir - Levemir Indications: Controlling hyperglycemia in type 1 and type 2 diabetes mellitus.

Pharmacodynamics: Decreases circulating blood glucose through stimulating glucose intake i n skeletal muscle and fat; inhibits hepatic glucose production. Pharmacokinetics: Absorption: Delayed and prolonged systemically. Distribution: Widely distributed. Metabolism: Hepatic, renal, splenic, and muscular metabolism. Excretion: Hepatic, renal, splenic, and muscular metabolism. Half - life: Dose -dependent, but usually 5 to 7 hours. Onset: 3 to 4 hours Peak: 3 to 14 hours. Duration: 6 to 24 hours.

Route: Subcutaneous injection - 0.1 to

0.2 units/kg once daily in the evening; also, 10 units once or tw ice daily.







- Corticosteroids, t hyroid supplements, estrogens can increase insulin requirements.



- Coenzyme Q - 10 can cause additional hy poglycemic effects.






Pregna ncy Category: Category C

Levemir: $109.79 -10mL vial; $211.79 -pen -

Pancreatics--Long ActingInsulin Glargine - Lantus Indications: Controlling hyperglycemia in type 1 and type 2 diabetes mellitus.

Pharmacodynamics: Decreases circulating blood glucose through stimulating glucose intake in skeletal muscle and fat; inhibits hepatic glucose production . Pharmacokinetics: Absorption: Provides slower prolonged absorption with a relatively constant concentration over 24 hours. Distribution: Widely distributed. Metabolism: Partially metabolized at injection site to active insulin metabolites. Hepatic, rena l, splenic, and muscular metabolism. Excretion: Hepatic, renal, splenic, and muscular metabolism. Half - life: 5 to 6 minutes. Onset: 3 to 4 hours. Peak: None. Duration: 24 hours.

Route: Subcutaneous injection - Dependent

upon blood glucose, personal response to drug. Ranges from 2 to 100 units/day. Conversion from an intermediate or other long acting insulin means using 80% of total NPH or other dose once daily, then adjusting based on patient’s needs.



lipodystro phy, erythema, edema, pruritis.





- Alco hol, ACE inhibitors, MAO inhibitors, oral hypoglycemics, salicylates may decrease insulin requirements.



Contraindications: - Hypoglycemia. - Allergy/hypersen sitivity

to insulin glargine. Cautions: - Stress and infection




Vials: - 10mL:

$84.99.

Pens: - 3mL: $107.79 -pen

Pancreatics--MixturesDrug Name Efficacy Dose Safety Suitability Cost of

Treatment Insulin Lispro Protamine Suspension/Insulin Lispro Injection Mixture - Humalog Mix

75/25 - Humalog Mix

50/50 Indications: Controlling hyperglycemia in type 1 and type 2 diabetes mellitus.

Pharmacod ynamics: Decreases circulating blood glucose through stimulating glucose intake in skeletal muscle and fat; inhibits hepatic glucose production. Pharmacokinetics: Absorption: Well absorbed from subcutaneous administration sites. Absorption rate determined by type of insulin, injection site, volume of injection, and other factors. Distribution: Widely distributed. Metabolism: Hepatic, renal, splenic, and muscular metabolism. Excretion: Hepatic, renal, splenic, and muscular metabolism. Half - life: 5 to 6 min utes. Onset: 15 to 30 minutes. Peak: 2.8 hours. Duration: 24 hours.


dependent upon blood glucose, personal response to drug. Usual total dose per day is 0.5 to 1 unit/kg/day total..


hypoglycemia . - Local:









Contraindications: - Hypoglycemi a. - Allergy/hypersensitivity






Vials: - 10mL:

$91.25.

Pens: - 3mL:

$147.50 for 5 pens.

Pancreatics--MixturesInsulin Aspart Protamine Suspension/Insulin Aspart Injection Mixtures - NovoLog Mix

70/30 - NovoLog Mix


Pharmacodynamics: Decreases circulating blood glucose through stimulat ing glucose intake in skeletal muscle and fat; inhibits hepatic glucose production. Pharmacokinetics: Absorption: Well absorbed from subcutaneous administration sites. Absorption rate determined by type of insulin, injection site, volume of injection, and other factors. Distribution: Widely distributed. Metabolism: Hepatic, renal, splenic, and muscular metabolism. Excretion: Hepatic, renal, splenic, and muscular metabolism. Half - life: 5 to 6 minutes. Onset: 15 minutes. Peak: 1 to 4 hours. Duration: 18 to 24 hours.


dependent upon blood glucose, personal response to drug. Usual total dose per day is 0.5 to 1 unit/kg/day total.




- Miscella neous: allergic/anaphyl- atic reaction.




- Alcohol, ACE inhibitors, MAO inhibitors, ora l hypoglycemics, salicylates may decrease insulin requirements.









Vials: - 10mL:

$85.99.

NovoLog 70/30: $110.79 -10mL vial; $218.79 -pen

Pancreatics--MixturesNPH/Regular Insulin Mixture - Humulin

70/30 - Novolin


Pharmacodynamics: Decreases circulating blood glucose through stimulating glucose intake in skeletal muscle and fat; inh ibits hepatic glucose production. Pharmacokinetics: Absorption: Well absorbed from subcutaneous administration sites. Absorption rate determined by type of insulin, injection site, volume of injection, and other factors. Distribution: Widely distributed. Metabolism: Hepatic, renal, splenic, and muscular metabolism. Excretion: Hepatic, renal, splenic, and muscular metabolism. Half - life: 5 to 6 minutes. Onset: 30 minutes. Peak: 4 to 8 hours. Duration: 24 hours.


dependent upon blood glucose, personal response to drug. Usual total dose per day is 0.5 to 1 unit/kg/day total..





Drug Interactio ns: - Beta - blockers,



- Alcohol, ACE inhibitors, MAO inhibitors, oral hypoglycemics, salicylates may decrease insulin requi rements.






(increase in sulin requirements).



Vials: - 10mL:

$42.99.

Pens: - 3mL:

$117.05 for 5 pens.

HormonesDrug Name Efficacy Dose Safety Suitability Cost of

Treatment Pramlintide - Symlin Indications: With mealtime insulin, used to control circulating blood glucose in those who cannot control their circulating blood glucose with insulin alone.

Pharmacodynamics : Synthetic analogue of amylin, an endogenous pancreatic hormone that helps control postprandial hyperglycemia. Pharmacokinetics: Absorption: 30 to 40% absorped. Distribution: 60% protein bound. Metabolism: Renally metabolized. Excretion: Renally metaboli zed. Half - life: 48 minutes. Onset: rapid. Peak: 20 minutes. Duration: 3 hours.

Route: Subcutaneous injection - 15 mcg

immediately prior to major meals initially, then increased by 15 mcg every 3 days up to 60 mcg if no nausea occurs.

Side Effects: - Endocrin e:

hypoglycemia. - Injection site

reaction, systemic allergic reaction.

- Gastrointestinal: nausea, vomiting, anorexia, abdominal pain.

- Central Nervous System: dizziness, fatigue, headache.

- Respiratory: cough.

Drug Interactions: - Hypoglycemia when

used with ot her short - acting insulins (decrease pre -meal insulin by 50%).

- Atropine and anticholinergics can decrease gastric motility.

Contraindications: - Inability to

identify hypoglycemia.

- Hypersensitivity. - Gastroparesis. - Poor insulin

compliance. - HbA1C > 9%. Cautio ns: - Lactation. Pregnancy Category: Category C

Pens: - 1000

mcg/mL: $294.49 - 5 mL vial

Type I DM P-Drug TablesInsulin Lispro (Humalog): Rapid-acting

Efficacy Safety Suitability Cost

Mechanism of Action:

1.Stimulates peripheral glucose uptake and storage of glucose in the liver

2.Inhibits hepatic glucose production - gluconeogenesis

3.Inhibits lipolysis and proteolysis

4.Regulates glucose metabolism

Availability:

10 ml vial

3 ml vial

3 ml Penfill cartridges x 5 for the cartridge device, total of 15mls

(Luxura or Memoir pen)

3 ml prefilled pen devices x 5, total of 15mls

(Kwikpen)

Subcutaneous Route Dose: Base d on patient’s weight, carbohydrate factor and correction factor; generally 0.5 -1units/kg/day Absorption: rapid with onset of 5 - 15 minutes, peak at 1.5 hours and duration of 3 - 5 hours ; absorption varies with site of injection Bioavailability: 55 - 77% Distr ibution: Wide; 0.26 -0.36L/kg Metabolism: Liver, Kidney, fat; does not interact with CYP450 Excretion: urine, t1/2 = 1 hour

Side effects: Hypoglycemia, hypokalemia, generalized hypersensitivity reaction (rare), anaphylaxis, lipodystrophy at injection site , pruritis, rash, weight gain Pregnancy: Category B

Contraindications: Renal impairment, Hepatic impairment, hypoglycemia. Caution: may need to increase doses for stress, pregnancy and infection as resistance to insulin increases Interactions: Insuli n may need to be increased with the following meds: corticosteroids, isoniazid, niacin, estrogens, oral contraceptives, phenothiazines, thyroid replacement therapy. Insulin may need to be decreased with the following: Anabolic steroids, alcohol, MAOis, most NSAIDs, oral hypoglycemic agents, tetracyclines, warfarin, clofibrate, phenylbutazone. Patients may lose ability to feel hypoglycemia

Vial : 100units/ml; 10mls $118 Cartridges: 1 box of 5, 300 units per cartridge, $220

Type I DM P-Drug TablesInsulin Aspart (Novolog): Rapid-acting



1. Stimulates peripheral glucose uptake and storage of glucose in the liver

2. Inhibits hepatic glucose production - gluconeogenesis

3. Inhibits lipolysis and proteolys is

4. Regulates glucose metabolism

Availability: 10 ml vial 3 ml Penfill cartridges x 5 for the cartridge device, total of 15mls (Novopen 3 device) 3 ml prefilled pen devices x 5, total of 15mls (Novolog Flexpen)

Subcutaneous Route Dose: Based on patient’ s weight, carbohydrate factor and correction factor; generally 0.5 -1units/kg/day Absorption: rapid with onset of 5 - 15 minutes, peak at 1.5 hours and duration of 3 - 5 hours ; absorption varies with site of injection Bioavailability: 55- 77% Distribution: Wide; 0.26 -0.36L/kg Metabolism: Liver, Kidney, fat; does not interact with CYP450 Excretion: urine, t1/2 = 81 minutes

Side effects: Hypoglycemia, hypokalemia, generalized hypersensitivity reaction (rare), anaphylaxis, lipodystrophy at injection site, pr uritis, rash, weight gain, myalgia Pregnancy: Category B

Contraindications: Renal impairment, Hepatic impairment, hypoglycemia Caution: may need to increase doses for stress, pregnancy and infection as resistance to insulin increases Interactions: I nsulin may need to be increased with the following meds: corticosteroids, isoniazid, niacin, estrogens, oral contraceptives, phenothiazines, thyroid replacement therapy. Insulin may need to be decreased with the following: Anabolic steroids, alcohol, MAO is, most NSAIDs, oral hypoglycemic agents, tetracyclines, warfarin, clofibrate, phenylbutazone, ACE inhibitors.


Type I DM P-Drug TablesInsulin Glulisine (Apidra): Rapid-acting





3. Inhibits lipolysis and proteol ysis


Availability: 10 ml vial 3 ml Penfill cartridges x 5 for the cartridge device, total of 15mls (Opticlik pen) 3 ml prefilled pen devices x 5, total of 15mls (Apidra Solostar)

Subcutaneous Route Dose: Based on patient’s weight, carbohydrate factor and correction factor; generally 0.5 -1units/kg/day Absorption: rapid with onset of 30 minutes, peak at 30 - 90 minutes and duration of 3 - 5 hours ; absorption varies with site of injection Bioavailability: 55- 77% Distribution: Wide; 0.26 -0.36L/kg Metabolism: Liver, Kidney, fat; does not interact with CYP450 Excretion: urine, t1/2 = 42 minutes

Side effects: Hypoglycemia, hypokalemia, generalized hypersensitivity reaction (rare), anaphylaxis, lipodystrophy at injection site, pr uritis, rash, weight gain, myalgia, peripheral edema, nasopharyngitis, respiratory infection, influenza, headache (peds), arthalgia, hypertension Pregnancy: Category C

Contraindications: Renal impairment, Hepatic impairment, hypersensitivity to metacre sol, hypoglycemia. Caution: may need to increase doses for stress, pregnancy and infection as resistance to insulin increases Interactions: Insulin may need to be increased with the following meds: corticosteroids, isoniazid, niacin, estrogens, oral co ntraceptives, phenothiazines, thyroid replacement therapy, sympathomimetics. Insulin may need to be decreased with the following: Anabolic steroids, alcohol, MAOis, most NSAIDs, oral hypoglycemic agents, tetracyclines, warfarin, clofibrate, phenylbutazone , ACE inhibitors.


Type I DM P-Drug TablesInsulin Glargine (Lantus): Long acting





3. Inhibits lipolysis and proteolys is


Availability: 10 ml vial 3 ml prefilled pen devices x 5, total of 15mls (Lantus Solostar)

Subcutaneous Route Dose: Use with rapid or short - acting insulin; QD dosing, generally 0.5 -1units/kg/day; must NOT be mixed Absorpt ion: onset of 1 hour, no peak, and duration of 24 hours ; absorption varies with site of injection Bioavailability: 72% Distribution: Metabolism: partial metabolism at carboxyl terminus of B chain in the SQ depot to form two active metabolites – M1 and M2; does not interact with CYP450 Excretion: urine

Side effects: Hypoglycemia, hypokalemia, generalized hypersensitivity reaction (rare), anaphylaxis, lipodystrophy at injection site, pruritis, rash, weight gain, sodium retention, edema Pregnancy: Cate gory C

Contraindications: Renal impairment, Hepatic impairment Caution: may need to increase doses for stress, pregnancy and infection as resistance to insulin increases Interactions: Insulin may need to be increased with the following meds: corticost eroids, isoniazid, niacin, estrogens, oral contraceptives, phenothiazines, thyroid replacement therapy, diuretics, sympathomimetics, atypical antipsychotics Insulin may need to be decreased with the following: Anabolic steroids, alcohol, MAOis, most NSAID s, oral hypoglycemic agents, fibrates, tetracyclines, warfarin, clofibrate, phenylbutazone, ACE inhibitors.


Type I DM P-Drug Tables Insulin Detemir (Levemir): Long acting

Efficacy

Safety

Suitability

Cost




3. Inhibits lipolysis and prot eolysis


Availability: 10 ml vial 3 ml prefilled pen devices x 5, total of 15mls (Levemir flexpen) 3 ml pen cartridges

Subcutaneous Route Dose: Use with rapid or short - acting insulin; QD or BID dosing, generally 0.5 -1units/k g/day; should NOT be mixed with other insulins. Absorption: onset of 1 hour, no peak, and duration of 6 - 23 hours ; absorption varies with site of injection Bioavailability: 60% Distribution: 98% bound to albumin, Vd = 0.1 L/kg Metabolism: unknown Exc retion: urine, t1/2 = 5 - 7 hours

Side effects: Hypoglycemia, hypokalemia, generalized hypersensitivity reaction (rare), anaphylaxis, lipodystrophy at injection site, pruritis, rash, weight gain, sodium retention, edema Pregnancy: Category C

Contraindic ations: Renal impairment, Hepatic impairment Caution: may need to increase doses for stress, pregnancy and infection as resistance to insulin increases Interactions: Insulin may need to be increased with the following meds: corticosteroids, isoniazid, n iacin, estrogens, oral contraceptives, phenothiazines, thyroid replacement therapy, diuretics, sympathomimetics, atypical antipsychotics Insulin may need to be decreased with the following: Anabolic steroids, alcohol, MAOis, most NSAIDs, oral hypoglycemic agents, fibrates, tetracyclines, warfarin, clofibrate, phenylbutazone, ACE inhibitors.


Rationale for Selecting P-drug (Rapid-Acting Insulin)

Efficacy Safety Suitability Cost Insulin Lispro (Humalog)

+ + + -

Insulin Aspart (Novolog)

+ + + +/-

Insulin Glulisine (Apidra)

+ - + -

Rationale for Selecting P-drug (Long-Acting Insulin)

Efficacy Safety Suitability Cost Insuline Glargine (Lantus)

+ + + -

Insulin Detemir (Levemir)

+ + +/- -

Selected p-drug combination: insuline glargine (Lantus) +

insulin aspart (Novolog)• Rationale for choosing combined therapy of

insulin glargine (Lantus) + insulin aspart (Novolog)

• Recommended therapy according to American Diabetes Association Clinical Guideline 2010:

• Recommended therapy for type 1 diabetes consists of the following components: 1) use of multiple dose insulin injections (3 to 4 injections per day of basal and prandial insulin) or continuous subcutaneous insulin infusion (CSII) therapy; 2) matching of prandial insulin to carbohydrate intake, premeal blood glucose, and anticipated activity; and 3) for many patients (especially if hypoglycemia is a problem), use of insulin analogs.

• Less expensive than CSII therapy, despite no difference in glycemic control (Bolli et al, 2009)

Rationale for choosing insulin glargine

• Can be given just 1 time daily (usually at night before bed) – better compliance

• Proven to provide better glycemic control when used with rapid-acting insulin (like insulin aspart or lispro) than compared to NPH and regular insulin therapy (Sharplin et al, 2009)

Rationale for choosing insulin aspart

• Shown to be as effective in stabilizing blood glucose rapidly as insulin lispro (Homko et al, 2003)

• More cost effective than insulin lispro

Insulin• Main Action:

• Lower blood glucose by stimulating glucose uptake in skeletal muscle and fat

• Also inhibit lipolysis and proteolysis, enhances protein synthesis

• Indication:

• Control of hyperglycemia in patients with Type I or Type II Diabetes Mellitus

Pharmacokinetics & Pharmacodynamics

Insulin glargine (Lantus)= long acting

Insulin aspart (NovoLog)= rapid acting

Absorption Slow, prolonged with constant concentrations over 24 hrs

Distribution Identical to endogenous insulin

Identical to endogenous insulin

Metabolism Liver, spleen, kidney, muscle

Liver, spleen, kidney, muscle

Route Subcutaneous injection Subcutaneous injection Onset 3-4 hrs 0.17-0.33 hr (15-30

min) Peak None 1-3 hrs Duration 24 hrs 3-5 hrs

Drug Cautions• Contraindications:

• Hypoglycemia

• Allergy or hypersensitivity to insulin glargine

• Caution:

• Stress, infection – decrease insulin requirements

• Renal or hepatic impairment – may decrease insulin requirements

• Pediatrics – safety not established in pts < 6yrs old

• Pregnancy – may temporarily increase insulin requirements

• Adverse Reactions/Side Effects:

• Endo: Hypoglycemia

• Local: lipodystrophy, pruritus, erythema, swelling

• Misc: allergic reactions (anaphylaxis)

Drug Interactions

• Interactions

• Drug-drug:

• Beta-blockers, clonidine, reserpine – may mask signs/sx of hypoglycemia

• Corticosteroids, thyroid supplements, estrogens, isoniazid, niacin, phenothiazines, rifampin – may increase insulin requirements

• Alcohol, ACE inhibitors, MAO inhibitors, salicylates – may decrease insulin requirements

• Drug-herbal:

• Glucosamine – may worsen blood glucose control

• Fenugreek, chromium, conenzyme q10 – may give additive hypoglycemic effects

Patient Education & Teaching

Determining Insulin regimen

• To determine total daily dose of insulin in units = (Multiply by 0.3 to 0.6) x (weight in kg)

Example of Beth: (0.3) x (58.967) = 17.7 ~ 17 units

• May need to increase insulin requirements later depending on glucose control

• 40-50% of daily insulin requirements will be given in long-acting insulin (insulin glargine)

Example of Beth: 17 units / 2 = 8.5 units

• Rest of insulin requirements to be given throughout the day with meals and snacks as rapid-acting insulin (insulin aspart)

Carbohydrate Coverage• Example: if your insulin to carbohydrate ratio is 1:10 and you eat

20 g of carbs for lunch 20 g/10 = 2 units of insulin to cover your meal

• Correction factor for high glucose:

[(Actual blood sugar) – (Target blood sugar)] / [Correction Factor]

• Total Meal Dose = (units for CHO) + (units for high glucose correction)

Example: if Beth’s pre-lunch glucose is 220 mg/dL and her target is 120 mg/dL with a correction factor of 50, and she plans to eat 20 g of carbs (with a insulin to carb ratio of 10)

• High sugar correction = (220 – 120)/(50) = 2 units

• CHO = 20/10 = 2 units

• Total meal insulin = 2 units + 2 units = 4 units

Storage/Preparation

• Do not mix insulin glargine with any other insulin or solution; do not use same syringe

• May mix insulin aspart with other types of insulin

• First draw insulin aspart into syringe

• Store unopened vials and cartridges in refrigerator; do not freeze

Administration

• Give insulin glargine at approximately the same time every day, usually before bedtime

• Give insulin aspart right before or right after meals

• Importance of selection & rotation of injection sites (abdominal wall, thigh, or upper arm)

• Importance of compliance with regimen

Monitoring• Instruction in proper testing of serum glucose

3 or more times per day (ADA Clinical Guidelines, 2010)

Before all meals

• Instruction in testing of ketones

Especially important during times of stress or illness

• Instruction in signs/sx of hypoglycemia

Nervousness, sweating, hunger, trembling, weakness, palpitations

Carry around source of glucose at all times (candy, glucose gel)

• Monitoring Hemoglobin A1C (goal < 7%)

2-3 times per year in patients with good glycemic control

4 times per year in patients whose glucose needs have changed or who show poor glycemic control

Follow/Up

• Schedule a visit to office in 2-3 days to go over blood glucose readings, correction factors, and carbohydrate ratios in order to optimize insulin requirements

• Schedule appointment for 3 month follow up visits to monitor Hgb A1c and fasting blood glucose until treatment is stable

• Encourage pt to maintain physical activity routine and encourage healthy eating

• Encourage yearly appointments with primary care provider to monitor cardiovascular health, esp d/t family history

Are they both in the Ohio

Board of Nursing Formulary?

• Yes, under Section 3 – Endocrine & Metabolic Agents – INSULIN

• Note: If giving insulin aspart as IV, must do so with institution approved protocol

May APNs prescribe?

• Yes, with CTP

Example of Written Prescription:• Gus Hudson-Vadnais, CFNP

• 123 Somewhere Road, Columbus, OH 43210

• 614-123-4567 (office)

• Date of Prescription: Aug 2, 2010

• Patient Name: Beth Smith

• Patient Weight: 130 lbs (58.967 kg)

• Patient Address: 123 Somewhere Road, Columbus, OH 43210

• Rx:

• Insulin glargine, 5 x 3mL cartridges for use with OptiPen One Insulin Delivery Device

– o Give 8.5 units one time a day at bedtime

– o Administer to back of arm, thigh, or abdomen

• Insulin aspart, 5 x 3mL cartridges (100 units/mL)

– o Pt taking up to 10 units per day. Dose subject to change as ratios change

– Take blood glucose reading prior to each meal

– o Administer insulin aspart based on appropriate carbohydrate ratio and high blood sugar correction factor

• Please schedule a follow-up visit to my office in 2-3 days.

• Prescriber Signature: Gus Hudson-Vadnais Date: 8-2-2010

Clinical Studies

Homko, C., Deluzio, A., Jimenez, C., Kolaczynski, J. W., & Boden, G. (2003). Comparison of insulin aspart and lispro: pharmacokinetic and metabolic effects. Diabetes Care, 26(7), 2027-31.• Objectives: To compare insulin levels and actions in patients with type 1

diabetes after subcutaneous injection of the rapid-acting insulin analogs aspart and lispro.

• Population: 7 patients with type I diabetes (2 male, 5 female)

• 5 used insulin pumps (CSII)

• 2 used MDI regimen

• Method: • Participants were studied at the General Clinical Research Center at

Temple University Hospital two times, 1 month apart

• Plasma glucose was normalized overnight by intravenous infusion of insulin

• next morning, they received SQ injections of either aspart or lispro in random order

• Over the next 4–5 h, their plasma glucose was clamped at ~5.5 mmol/l with a variable infusion of 20% glucose.

• Study ended after 8 h

• Results:

• Actions of both insulin lispro and aspart are the same in terms of effect on carbohydrate and lipid metabolism

• Found them to be equally effective in treating diabetic patients

Bolli, G. B., Kerr, D., Thomas, R., Torlone, E., Sola-Gazagnes, A., Vitacolonna, E., Selam, J. L., & Home, P. D. (2009). Comparison of a multiple daily insulin injection regimen (basal once-daily glargine plus mealtime lispro) and continuous subcutaneous insulin infusion (lispro) in type 1 diabetes: a randomized open parallel multicenter study. Diabetes Care, 32(10), 1170-76.

• Objectives: to assess the difference in glycemic control when people with type 1 diabetes using NPH insulin-based MDIs

• Population: • 58 participants ages 18–70 years from 3 European countries

– o BMI ≤ 27.0 kg/m2

– o diabetes for > 1 year

– o Hbg A1c between 6.5–9.0%

– o currently using an MDI regimen with NPH insulin

• Excluded participants with hepatic or renal impairments

• Method: • People with type 1 diabetes on NPH-based insulin therapy were randomized to

CSII or glargine-based MDI (both otherwise using lispro)

• Participants asked to perform 3-4 daily insulin checks (before meals and bedtime)

• Results:• Both regimens showed similar results in terms of insulin dose, blood glucose

control, hypoglycemic events, treatment satisfaction

• Cost was lower for MDI regimen

http://www.ncbi.nlm.nih.gov.proxy.lib.ohio-state.edu/pubmed/19389820










Sharplin, P., Gordon, J., Peters, J. R., Tetlow, A. P., Longman, A. J., & McEwan, P. (2009). Improved glycaemic control by switching from insulin NPH to insulin glargine: a retrospective observational study. Cardiovascular Diabetology, 8(3), 1-8.

• Objectives: To assess the impact on hemoglobin A1C, weight, and insulin use of switching from NPH (Neutral Protamine Hagedorn) to insulin glargine

• Population: 701 total patients from a United Kingdom primary care network• 304 (43%) with type 1 diabetes

• 397 (57%) with type 2 diabetes

• Method: • 24 month, nonrandomized, retrospective observational study

• Data extracted from a UK primary care database (The Health Improvement Network) between 2002-2005

• Patients were required to have at least 12 months of data before and after switching from NPH to glargine

• Primary analysis: the change in HbA1c after 12 months treatment with insulin glargine

• Secondary analyses: change in weight and total daily insulin dose

• Results: in diabetes patients treated with NPH and with evidence of suboptimal efficacy and/or poor tolerability, switching to insulin glargine offers opportunity for improved glycaemic control

References--MaterialsAmerican Diabetes Association (2010). Standards of medical care in diabetes. V. Diabetes

care. Diabetes Care, Suppl 1: S16-29.

Blong, Lawrence, et. al. (2007). American association of clincal endocrinologists medical guidelines for clinical practice for the management of diabetes mellitus.Endocrine Practice, Vol. 13 (Suppl 1: footnotes in powerpoint 1-6.

Bolli, G. B., Kerr, D., Thomas, R., Torlone, E., Sola-Gazagnes, A., Vitacolonna, E., Selam, J. L., & Home, P. D. (2009). Comparison of a multiple daily insulin injection regimen (basal once-daily glargine plus mealtime lispro) and continuous subcutaneous insulin infusion (lispro) in type 1 diabetes: a randomized open parallel multicenter study. Diabetes Care, 32(10), 1170-76.

Davis’s Drug Guide (2000-2010). Unbound Medicine [PDA software].

Diabetes Education Online (2010). Diabetes Teaching Center at the University of San Francisco. Retrieved July 23, 2010 from http://www.deo.ucsf.edu/type1/diabetes-treatment/medications-and-therapies/type-1-insulin-rx/calculating-insuliin-dose.html.

Homko, C., Deluzio, A., Jimenez, C., Kolaczynski, J. W., & Boden, G. (2003). Comparison of insulin aspart and lispro: pharmacokinetic and metabolic effects. Diabetes Care, 26(7), 2027-31.

Katzung, B. G, Masters, S.B., & Trevor, A. J. (2009) Basic & Clinical Pharmacology (11th ed). New York: The McGraw-Hill. ISBN: 978-0-07-160405-5.

Sharplin, P., Gordon, J., Peters, J. R., Tetlow, A. P., Longman, A. J., & McEwan, P. (2009). Improved glycaemic control by switching from insulin NPH to insulin glargine: a retrospective observational study. Cardiovascular Diabetology, 8(3), 1-8.










http://www.deo.ucsf.edu/type1/diabetes-treatment/medications-and-therapies/type-1-insulin-rx/calculating-insuliin-dose.html






References--Tables

Katzung, B.G., Masters, S.B., & Trevor, A.J. (2009) Basic and Clinical Pharmacology (11th ed). New York: The McGraw-Hill.

Lehne, R.A., (1998). Pharmacology for nursing care (3rd ed.). Philadelphia: W.B. Saunders Company. Deglin, J.H. & Vallerand, A.H. (1999)

Davis's Drug Guide (6th ed). Philadelphia: F.A. Davis Company. Epocrates Rx (2010). [database for PDA, Version 8.10]. San Mateo, CA: Epocrates, Inc. available from: http://www.epocrates.com.

http://www.epocrates.com/



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