SWITCH - Sensing With Insulin Pump Therapy to Control HbA1c | NCT00598663

ID	Type	Description	Link
ISRCTN09806152

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Off/On	Experimental	6 month-Period Off: Continuous Subcutaneous Insulin Infusion (CSII) and Self Monitoring Blood Glucose [Device: Paradigm® Real-Time pump with Sensor Off feature] 4 month wash out period 6 month-Period On: Continuous Subcutaneous Insulin Infusion (CSII) + personal continuous glucose monitoring (personal CGM) [Device: Paradigm® Real-Time pump with Sensor On feature continuously]	Device: insulin pump with continuous glucose sensing (Paradigm Real-Time Insulin Pump System)
On/Off	Experimental	6 month-Period On: Continuous Subcutaneous Insulin Infusion (CSII) + personal continuous glucose monitoring (personal CGM) [Device: Paradigm® Real-Time pump with Sensor On feature continuously] 4 month wash out period 6 month-Period Off: Continuous Subcutaneous Insulin Infusion (CSII) and Self Monitoring Blood Glucose [Device: Paradigm® Real-Time pump with Sensor Off feature]	Device: insulin pump and blinded continuous glucose sensing (Paradigm Real-Time insulin pump)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
insulin pump with continuous glucose sensing (Paradigm Real-Time Insulin Pump System)	Device	6 months of pump plus continuous glucose sensing in conjunction to SMBG	Off/On

Measure	Description	Time Frame
HbA1c at 6 Month	The end of period difference in HbA1c after 6 months of treatment	6 months

Measure	Description	Time Frame
Glycemic Variability	24 h SD of glucose values (mg/dl)	6 months
Number of Severe Hypoglycemia Events		6 months

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Type 1 diabetes mellitus diagnosed for at least 12 months prior to signature of informed consent,
Sub-optimal glycemic control (7.5%<HbA1c<9.5%).
Patient treated by continuous subcutaneous insulin infusion (CSII) for at least 6 months prior signature of informed consent.
Patient treated within the practice of the investigator's center at least 6 months prior signature of informed consent.
Patient has no preliminary experience with the sensor function of the Paradigm REAL-Time or the Guardian® REAL-Time for the 4 months prior signature of informed consent.

Exclusion Criteria:

Existing pregnancy or intention to conceive (as assessed by investigator).
Hearing or vision impairment so that glucose display and alarms cannot be recognized.
Three or more incidents in the last 12 months of severe hypoglycaemia with documented Blood Glucose below 50mg/dL (if possible), resulting in unconsciousness, hospitalisation or third party assistance, where recovery follows treatment with glucose or glucagon or similar.
History of hypoglycemic unawareness as assessed by the investigator.
Alcohol or drug abuse, other than nicotine.
Documented cutaneous allergy or disease (allergy to sensor or components of the sensor, psoriasis, staphylococcus, exanthema etc.).
Any documented concomitant chronic disease known to affect diabetes control (e.g. altered renal function, active cancer undergoing treatment, Crohn's disease, ulcerative colitis, Mb Addison disease) or any concomitant pharmacological treatment that might modify glycemic values (e.g chronic corticosteroid therapy), eating disorders and morbid obesity (defined as adults : Body Mass Index >35 and children Body Mass Index > 2 standard deviations. for age) as assessed by the investigator.
Any other medical, social or psychological condition that, in the investigator's opinion, makes the patient unable to comply with the study protocol and all study procedures.
For pediatric subjects: does not have a reliable support person.
Plans to travel for extended periods (3+ weeks) where the devices cannot be supplied or replaced and/or medical support is limited (eg. exotic countries, remote places).
Participation in another clinical study, on-going or completed less than 3 months prior to signature of Patient Informed Consent.

Name	Affiliation	Role
Dr. T Battelino	University Children's Hospital	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Hospital Hietzing		Vienna			Austria
Steno Diabetes Center

PubMed Identifier	Type	Citation	Retractions
22965294	Derived	Battelino T, Conget I, Olsen B, Schutz-Fuhrmann I, Hommel E, Hoogma R, Schierloh U, Sulli N, Bolinder J; SWITCH Study Group. The use and efficacy of continuous glucose monitoring in type 1 diabetes treated with insulin pump therapy: a randomised controlled trial. Diabetologia. 2012 Dec;55(12):3155-62. doi: 10.1007/s00125-012-2708-9. Epub 2012 Sep 11.

ID	Title	Description
FG000	Off/On	Sequence Off/On 6 month-Period Off: Continuous Subcutaneous Insulin Infusion (CSII, (Paradigm Real-Time Insulin Pump System) and Self Monitoring Blood Glucose Wash out period: 4 months 6 month-Period On: Continuous Subcutaneous Insulin Infusion (CSII, (Paradigm Real-Time Insulin Pump System) + personal continuous glucose monitoring (personal CGM)

ID	Title	Description
BG000	Off/On	6 month-Period Off: Continuous Subcutaneous Insulin Infusion (CSII) and Self Monitoring Blood Glucose [Device: Paradigm® Real-Time pump with Sensor Off feature] 4 month wash out period 6 month-Period On: Continuous Subcutaneous Insulin Infusion (CSII) + personal continuous glucose monitoring (personal CGM) [Device: Paradigm® Real-Time pump with Sensor On feature continuously]
BG001	On/Off	6 month-Period On: Continuous Subcutaneous Insulin Infusion (CSII) + personal continuous glucose monitoring (personal CGM) [Device: Paradigm® Real-Time pump with Sensor On feature continuously] 4 month wash out period 6 month-Period Off: Continuous Subcutaneous Insulin Infusion (CSII) and Self Monitoring Blood Glucose [Device: Paradigm® Real-Time pump with Sensor Off feature]
BG002	Total	Total of all reporting groups

Units	Counts
Participants	BG00076 BG00177 BG002153

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

HbA1c at 6 Month

The end of period difference in HbA1c after 6 months of treatment

Posted

Mean

Standard Deviation

percentage of glycosylated hemoglobin

6 months

ID	Title	Description
OG000	Sensor Off Arm	6 month-Period Off: Continuous Subcutaneous Insulin Infusion (CSII) and Self Monitoring Blood Glucose [Device: Paradigm® Real-Time pump with Sensor Off feature] Arms/Groups are reported on a "per intervention" basis
OG001	Sensor ON Arm	6 month-Period On: Continuous Subcutaneous Insulin Infusion (CSII) + personal continuous glucose monitoring (personal CGM) [Device: Paradigm® Real-Time pump with Sensor On feature continuously] Arms/Groups are reported on a "per intervention" basis

Units	Counts
Participants	OG000153 OG001153

Title

Denominators

Categories

Title	Measurements
	OG0008.47± 0.96 OG0018.04± 0.87

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001		ANCOVA	ANOVA with adjustment for period effect and subject as random effect. Period was included in the model regardless of statistical significance.	<0.0001		Mean Difference (Final Values)	0.43			1-Sided	97.5							Superiority

Secondary

Glycemic Variability

24 h SD of glucose values (mg/dl)

Posted

Mean

Standard Deviation

mg/dl

6 months

ID	Title	Description
OG000	Sensor Off Arm	6 month-Period Off: Continuous Subcutaneous Insulin Infusion (CSII) and Self Monitoring Blood Glucose [Device: Paradigm® Real-Time pump with Sensor Off feature] Arms/Groups are reported on a "per intervention" basis
OG001	Sensor On Arm	6 month-Period On: Continuous Subcutaneous Insulin Infusion (CSII) + personal continuous glucose monitoring (personal CGM) [Device: Paradigm® Real-Time pump with Sensor On feature continuously] Arms/Groups are reported on a "per intervention" basis

Units	Counts
Participants	OG000

Secondary

Number of Severe Hypoglycemia Events

Posted

Number

participants

6 months

ID	Title	Description
OG000	Sensor Off	6 month-Period Off: Continuous Subcutaneous Insulin Infusion (CSII) and Self Monitoring Blood Glucose [Device: Paradigm® Real-Time pump with Sensor Off feature] Arms/Groups are reported on a "per intervention" basis
OG001	Sensor On	6 month-Period On: Continuous Subcutaneous Insulin Infusion (CSII) + personal continuous glucose monitoring (personal CGM) [Device: Paradigm® Real-Time pump with Sensor On feature continuously] Arms/Groups are reported on a "per intervention" basis

Units	Counts
Participants	OG000

Secondary

Daily Min Spent in Euglycaemia (3.9-10.0 mmol/l)

Posted

Mean

Standard Deviation

minutes

6 months

ID	Title	Description
OG000	Sensor Off Arm	6 month-Period Off: Continuous Subcutaneous Insulin Infusion (CSII) and Self Monitoring Blood Glucose [Device: Paradigm® Real-Time pump with Sensor Off feature] Arms/Groups are reported on a "per intervention" basis
OG001	Sensor ON Arm	6 month-Period On: Continuous Subcutaneous Insulin Infusion (CSII) + personal continuous glucose monitoring (personal CGM) [Device: Paradigm® Real-Time pump with Sensor On feature continuously] Arms/Groups are reported on a "per intervention" basis

Units	Counts
Participants	OG000

Secondary

Postprandial Glycaemia

Breakfast Postprandial glycaemia

Posted

Mean

Standard Deviation

mg/dl

6 months

ID	Title	Description
OG000	Sensor Off Arm	6 month-Period Off: Continuous Subcutaneous Insulin Infusion (CSII) and Self Monitoring Blood Glucose [Device: Paradigm® Real-Time pump with Sensor Off feature] Arms/Groups are reported on a "per intervention" basis
OG001	Sensor ON Arm	6 month-Period On: Continuous Subcutaneous Insulin Infusion (CSII) + personal continuous glucose monitoring (personal CGM) [Device: Paradigm® Real-Time pump with Sensor On feature continuously] Arms/Groups are reported on a "per intervention" basis

Units	Counts
Participants	OG000

Secondary

Pediatric Quality of Life Inventory (Vers 4.0; PedsQL)

This questionnaire is a validated assessment of health-related quality of life in children developed by J.W. Varni, (1998).

Scores are transformed on a scale from 0 to 100. higher values represent a better outcome

In total 72 children took part in the clinical trial: 8 young children (6-7 years), 26 children (8-12 years) and 38 teenagers (13-17 years). Arms/Groups are reported on a "per intervention" basis

Posted

Mean

Standard Deviation

units on a scale

6 months

ID	Title	Description
OG000	Sensor Off	6 month-Period Off: Continuous Subcutaneous Insulin Infusion (CSII) and Self Monitoring Blood Glucose [Device: Paradigm® Real-Time pump with Sensor Off feature] Arms/Groups are reported on a "per intervention" basis
OG001	Sensor On	6 month-Period On: Continuous Subcutaneous Insulin Infusion (CSII) + personal continuous glucose monitoring (personal CGM) [Device: Paradigm® Real-Time pump with Sensor On feature continuously] Arms/Groups are reported on a "per intervention" basis

Units	Counts
Participants

Secondary

Diabetic Ketoacidosis Events

A diabetic ketoacidosis event (DKE) is defined as a hyperglycemia (blood glucose >250 mg/dL) with either low serum bicarbonate (<15 mEq/L) and/or low pH (<7.3) and either ketonemia or ketonuria and requiring treatment within a health-care facility.

Posted

Count of Participants

Participants

6 months

ID	Title	Description
OG000	Sensor Off	6 month-Period Off: Continuous Subcutaneous Insulin Infusion (CSII) and Self Monitoring Blood Glucose [Device: Paradigm® Real-Time pump with Sensor Off feature] Arms/Groups are reported on a "per intervention" basis
OG001	Sensor On	6 month-Period On: Continuous Subcutaneous Insulin Infusion (CSII) + personal continuous glucose monitoring (personal CGM) [Device: Paradigm® Real-Time pump with Sensor On feature continuously] Arms/Groups are reported on a "per intervention" basis

Units	Counts
Participants	OG000

Other Adverse Events

Term	Organ System	Statistical Information
Abscess	Infections and infestations	EG0001 events1 affected153 at risk EG0010 events0 affected153 at risk
Abscess on buttock	Infections and infestations	EG0000 events0 affected153 at risk EG0011 events1 affected153 at risk
Acetonuria	Renal and urinary disorders	EG0000 events0 affected153 at risk EG0011 events1 affected153 at risk
Acute bronchitis	Infections and infestations	EG0001 events1 affected153 at risk EG0010 events0 affected153 at risk
Acute tonsillitis	Infections and infestations	EG0001 events1 affected153 at risk EG0010 events0 affected153 at risk
Adhesive tape allergy	Skin and subcutaneous tissue disorders	EG0002 events1 affected153 at risk EG0010 events0 affected153 at risk
Adverse event NOS	General disorders	EG0000 events0 affected153 at risk EG0012 events2 affected153 at risk
Allergy	Immune system disorders	EG0000 events0 affected153 at risk EG0011 events1 affected153 at risk
Aortic stenosis	Vascular disorders	EG0001 events1 affected153 at risk EG0010 events0 affected153 at risk
Arm fracture	Injury, poisoning and procedural complications	EG0000 events0 affected153 at risk EG0011 events1 affected153 at risk
Arthrosis	Musculoskeletal and connective tissue disorders	EG0001 events1 affected153 at risk EG0010 events0 affected153 at risk
Atopic dermatitis	Skin and subcutaneous tissue disorders	EG0000 events0 affected153 at risk EG0011 events1 affected153 at risk
Back disorder	Musculoskeletal and connective tissue disorders	EG0001 events1 affected153 at risk EG0010 events0 affected153 at risk
Back pain	Musculoskeletal and connective tissue disorders	EG0001 events1 affected153 at risk EG0010 events0 affected153 at risk
Basedow's disease	Endocrine disorders	EG0000 events0 affected153 at risk EG0011 events1 affected153 at risk
Bladder disorder	Renal and urinary disorders	EG0001 events1 affected153 at risk EG0010 events0 affected153 at risk
Blurred vision	Eye disorders	EG0002 events2 affected153 at risk EG0010 events0 affected153 at risk
Breast reconstruction	Surgical and medical procedures	EG0001 events1 affected153 at risk EG0011 events1 affected153 at risk
Bronchitis	Infections and infestations	EG0002 events2 affected153 at risk EG0010 events0 affected153 at risk
Catheter site dermatitis	General disorders	EG0001 events1 affected153 at risk EG0010 events0 affected153 at risk
Chronic cough	Respiratory, thoracic and mediastinal disorders	EG0000 events0 affected153 at risk EG0011 events1 affected153 at risk
Cold	Infections and infestations	EG00011 events10 affected153 at risk EG0018 events7 affected153 at risk
Common cold	Infections and infestations	EG0000 events0 affected153 at risk EG0013 events3 affected153 at risk
Conjunctivitis	Eye disorders	EG0000 events0 affected153 at risk EG0011 events1 affected153 at risk
Cystitis	Infections and infestations	EG0000 events0 affected153 at risk EG0011 events1 affected153 at risk
Depression	Psychiatric disorders	EG0000 events0 affected153 at risk EG0011 events1 affected153 at risk
Diarrhea	Gastrointestinal disorders	EG0001 events1 affected153 at risk EG0011 events1 affected153 at risk
Dizziness	Nervous system disorders	EG0000 events0 affected153 at risk EG0012 events2 affected153 at risk
Epileptic fit	Nervous system disorders	EG0000 events0 affected153 at risk EG0011 events1 affected153 at risk
Eye disorder	Eye disorders	EG0001 events1 affected153 at risk EG0010 events0 affected153 at risk
Fever	General disorders	EG0001 events1 affected153 at risk EG0010 events0 affected153 at risk
Flu	Infections and infestations	EG0006 events6 affected153 at risk EG0014 events2 affected153 at risk
Foot sprain	Injury, poisoning and procedural complications	EG0001 events1 affected153 at risk EG0010 events0 affected153 at risk
Gastroenteritis	Infections and infestations	EG00011 events11 affected153 at risk EG0013 events3 affected153 at risk
Gastroenterocolitis	Infections and infestations	EG0005 events5 affected153 at risk EG0010 events0 affected153 at risk
Headache	Nervous system disorders	EG0001 events1 affected153 at risk EG0010 events0 affected153 at risk
Hernia	General disorders	EG0000 events0 affected153 at risk EG0011 events1 affected153 at risk
Hypertension	Vascular disorders	EG0001 events1 affected153 at risk EG0010 events0 affected153 at risk
Impetigo	Infections and infestations	EG0001 events1 affected153 at risk EG0010 events0 affected153 at risk
Infected finger	Infections and infestations	EG0001 events1 affected153 at risk EG0010 events0 affected153 at risk
Infection	Infections and infestations	EG0001 events1 affected153 at risk EG0010 events0 affected153 at risk
Influenza	Infections and infestations	EG0001 events1 affected153 at risk EG0011 events1 affected153 at risk
Injection site infection	Infections and infestations	EG0000 events0 affected153 at risk EG0012 events2 affected153 at risk
Jaw inflammation	Musculoskeletal and connective tissue disorders	EG0001 events1 affected153 at risk EG0010 events0 affected153 at risk
Joint disorder	Musculoskeletal and connective tissue disorders	EG0000 events0 affected153 at risk EG0012 events2 affected153 at risk
Knee pain	Musculoskeletal and connective tissue disorders	EG0001 events1 affected153 at risk EG0011 events1 affected153 at risk
Laceration of hand	Injury, poisoning and procedural complications	EG0001 events1 affected153 at risk EG0010 events0 affected153 at risk
Lipohypertrophy	Skin and subcutaneous tissue disorders	EG0000 events0 affected153 at risk EG0011 events1 affected153 at risk
Lumbago	Musculoskeletal and connective tissue disorders	EG0000 events0 affected153 at risk EG0012 events1 affected153 at risk
Medical device site erythema	General disorders	EG0002 events2 affected153 at risk EG0010 events0 affected153 at risk
Medical device site hematoma	General disorders	EG0002 events1 affected153 at risk EG0010 events0 affected153 at risk
Medical device site hyperker	General disorders	EG0001 events1 affected153 at risk EG0012 events2 affected153 at risk
Medical device site infectio	Infections and infestations	EG0000 events0 affected153 at risk EG0011 events1 affected153 at risk
Medical device site irritati	General disorders	EG0000 events0 affected153 at risk EG0011 events1 affected153 at risk
Medical device site pain	General disorders	EG0000 events0 affected153 at risk EG0011 events1 affected153 at risk
Medical device site reaction	General disorders	EG0002 events2 affected153 at risk EG0010 events0 affected153 at risk
Mental distress	Psychiatric disorders	EG0001 events1 affected153 at risk EG0010 events0 affected153 at risk
Migraine	Nervous system disorders	EG0001 events1 affected153 at risk EG0010 events0 affected153 at risk
Myxedema	Endocrine disorders	EG0000 events0 affected153 at risk EG0011 events1 affected153 at risk
Nail injury	Injury, poisoning and procedural complications	EG0000 events0 affected153 at risk EG0011 events1 affected153 at risk
Obsessive-compulsive disorde	Psychiatric disorders	EG0000 events0 affected153 at risk EG0011 events1 affected153 at risk
Odontitis	Infections and infestations	EG0001 events1 affected153 at risk EG0010 events0 affected153 at risk
Otitis	Infections and infestations	EG0000 events0 affected153 at risk EG0011 events1 affected153 at risk
Paresthesia lower limb	Nervous system disorders	EG0000 events0 affected153 at risk EG0011 events1 affected153 at risk
Pharyngotonsillitis	Infections and infestations	EG0001 events1 affected153 at risk EG0011 events1 affected153 at risk
Plastic surgery	Surgical and medical procedures	EG0001 events1 affected153 at risk EG0010 events0 affected153 at risk
Pneumonia	Infections and infestations	EG0002 events2 affected153 at risk EG0010 events0 affected153 at risk
Polypectomy	Surgical and medical procedures	EG0000 events0 affected153 at risk EG0011 events1 affected153 at risk
Postoperative infection	Infections and infestations	EG0001 events1 affected153 at risk EG0010 events0 affected153 at risk
Post-traumatic wound infecti	Infections and infestations	EG0001 events1 affected153 at risk EG0011 events1 affected153 at risk
Pregnancy on contraceptive	Pregnancy, puerperium and perinatal conditions	EG0000 events0 affected153 at risk EG0011 events1 affected153 at risk
Prostatitis	Reproductive system and breast disorders	EG0000 events0 affected153 at risk EG0011 events1 affected153 at risk
Psychological disorder NOS	Psychiatric disorders	EG0001 events1 affected153 at risk EG0010 events0 affected153 at risk
Shoulder pain	Musculoskeletal and connective tissue disorders	EG0000 events0 affected153 at risk EG0011 events1 affected153 at risk
Sinusitis	Infections and infestations	EG0000 events0 affected153 at risk EG0011 events1 affected153 at risk
Skin eruption	Skin and subcutaneous tissue disorders	EG0001 events1 affected153 at risk EG0010 events0 affected153 at risk
Skin rash	Skin and subcutaneous tissue disorders	EG0000 events0 affected153 at risk EG0011 events1 affected153 at risk
Skin reaction	Skin and subcutaneous tissue disorders	EG0000 events0 affected153 at risk EG0011 events1 affected153 at risk
Sore throat	Respiratory, thoracic and mediastinal disorders	EG0000 events0 affected153 at risk EG0011 events1 affected153 at risk
Streptoderma	Infections and infestations	EG0000 events0 affected153 at risk EG0011 events1 affected153 at risk
Stress at work	Social circumstances	EG0000 events0 affected153 at risk EG0011 events1 affected153 at risk
Thorax pain	General disorders	EG0001 events1 affected153 at risk EG0010 events0 affected153 at risk
Thrombophlebitis	Vascular disorders	EG0001 events1 affected153 at risk EG0010 events0 affected153 at risk
Tibia fracture	Injury, poisoning and procedural complications	EG0001 events1 affected153 at risk EG0010 events0 affected153 at risk
Tonsillitis	Infections and infestations	EG0000 events0 affected153 at risk EG0013 events3 affected153 at risk
Tooth extraction	Surgical and medical procedures	EG0002 events2 affected153 at risk EG0010 events0 affected153 at risk
Tooth infection	Infections and infestations	EG0001 events1 affected153 at risk EG0011 events1 affected153 at risk
Tooth pain	Gastrointestinal disorders	EG0001 events1 affected153 at risk EG0010 events0 affected153 at risk
Upper respiratory tract infe	Infections and infestations	EG0006 events5 affected153 at risk EG0015 events3 affected153 at risk
Urinary tract infection	Infections and infestations	EG0001 events1 affected153 at risk EG0010 events0 affected153 at risk
Vertigo	Ear and labyrinth disorders	EG0001 events1 affected153 at risk EG0010 events0 affected153 at risk
Viral infection	Infections and infestations	EG0002 events2 affected153 at risk EG0014 events4 affected153 at risk
Vomiting	Gastrointestinal disorders	EG0001 events1 affected153 at risk EG0010 events0 affected153 at risk

ID	Term
D003920	Diabetes Mellitus
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases
D004700	Endocrine System Diseases
D001327	Autoimmune Diseases
D007154	Immune System Diseases

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Sensor Off	6 month-Period Off: Continuous Subcutaneous Insulin Infusion (CSII) and Self Monitoring Blood Glucose [Device: Paradigm® Real-Time pump with Sensor Off feature]	0	153	5	153	64	153
EG001	Sensor On	6 month-Period On: Continuous Subcutaneous Insulin Infusion (CSII) + personal continuous glucose monitoring (personal CGM) [Device: Paradigm® Real-Time pump with Sensor On feature continuously]	0	153	6	153	52	153

Term	Organ System	Source Vocabulary	Assessment Type	Notes	Statistical Information
Severe Hypoglycemic Event	Metabolism and nutrition disorders		Systematic Assessment	A Severe Hypoglycemic Event (SHE) is defined as an episode absolutely requiring assistance from another person and preferably accompanied by a confirmatory blood glucose by finger stick of less than 50mg/dL	EG0002 events2 affected153 at risk EG0014 events4 affected153 at risk
Diabetic Ketoacidosis	Metabolism and nutrition disorders		Systematic Assessment	A diabetic ketoacidosis event (DKE) is defined as a hyperglycemia (blood glucose >250 mg/dL) with either low serum bicarbonate (<15 mEq/L) and/or low pH (<7.3) and either ketonemia or ketonuria and requiring treatment within a health-care facility.	EG0004 events3 affected153 at risk EG0012 events2 affected153 at risk