Professional Continuous Glucose Monitoring Before Starting Insulin Pump Therapy
Phase: NA
Conditions: Type 1 Diabetes Mellitus
Sponsor: Children's Hospital Los Angeles

1/8/2016 
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Professional Continuous Glucose Monitoring Before Starting Insulin Pump 
Therapy 
Principal Investigator: Jessica Ferris, MD 
 
1.0 
BACKGROUND AND HYPOTHESIS 
 
Frequent blood glucose monitoring is the cornerstone of intensive diabetes management, and 
has been shown to decrease long-term complications of diabetes (1,2). Continue glucose 
monitoring has been a promising technology, providing patients and physicians with 
additional blood glucose data and a more detailed and accurate look at glycemic trends 
throughout the day, than can be achieved with SMBG alone, which may miss post-prandial 
and nocturnal variability (3-7). Continuous glucose monitors (CGM) can be divided into two 
groups: retrospective CGM and real-time CGM. Retrospective CGM devices are owned by 
the physician or clinic (i.e. iPro Professional CGM), and allow for blood glucose data to be 
collected over 3-7 days and then to be downloaded by the physician. The data are blinded to 
the patient during collection, and the downloaded data is used retrospectively to identify 
glycemic patterns and assist with insulin dose adjustments. Real-time CGM devices are 
owned by the patient, and provide minute-to-minute blood glucose values and trends, which 
are then used immediately to adjust insulin doses. Real-time CGM devices require intensive 
training and rely on the frequency of use, and have been found to be most effective when 
worn consistently (7,8).  
 
The insulin pump has been a useful vehicle to manage glycemic variation throughout the day. 
With the ability to titrate insulin doses to glycemic demand, insulin pump therapy has been 
shown to improve glycemic control and decrease hypoglycemic events, when compared to 
multiple daily injections (MDI) alone (9,10). Insulin pumps are now integrated with real-time 
CGM technology, which has improved glycemic control with consistent use (7,11). Sensor-
augmented pump (SAP) therapy has demonstrated reductions in HbA1c and decreased 
glycemic variability (7,11). Though, one of the major limitations found with SAP is that it 
must be used consistently by highly motivated families to achieve significant reductions in 
hemoglobin A1c (8,12).  Furthermore, patients are infrequently started on both insulin pump 
and real-time CGM at the same time, due to the degree of training required to master two 
technologic devices. However, retrospective CGM data may be used to capture glycemic 
patterns, without the need for extensive education or training for the patient. 
 
It has been the experience at our institution that patients are rarely started on both insulin 
pump and CGM simultaneously, primarily because learning two devices can be 
overwhelming for families. If a CGM is desired, the sensor is typically added about 1-2 
months after initiation of pump therapy. It has also been our experience that patients starting 
on pump therapy require frequent dose adjustments before achieving tight glycemic control. 
Many studies have tried to identify variations in insulin requirements throughout the day (13-
15), as well as variations based on age and pubertal stage (16). From these studies, as well as 
clinical experience, physicians understand that most children on pump therapy need less total 
daily insulin and higher basal rates in the early morning. These studies have provided a 

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general knowledge for initial insulin pump doses. However, an individualized regimen that 
provides tight glycemic control does not evolve until later, after many dose adjustments. 
 
Though there has been much research looking at glycemic control when CGM is used with 
pump, there is little research looking at the utility of using CGM prior to initiation of insulin 
pump therapy.  CGM has been used as a tool to monitor variations in blood glucose during 
the initiation of pump therapy (17,18), but not yet studied as means to tailor initial insulin 
pump doses.  
 
We hypothesize that using retrospective CGM data in youth with type 1 diabetes mellitus to 
inform starting insulin doses at the initiation of pump therapy will result in the selection of 
more physiologic starting doses resulting in an improved time within target BG within the 
first 6 weeks of pump therapy. 
 
 
2.0 
OBJECTIVES AND PURPOSE 
 
The primary objective of this study is to demonstrate that the use of retrospective CGM 
before insulin pump initiation will decrease glycemic variability, as measured by an 
increase in percentage time within target blood glucose range, in the first 6 weeks of 
pump therapy when compared to standard care, which in turn may change the standard of 
practice for how endocrinologists approach insulin pump initiation. By using CGM in the 
weeks before pump initiation, an accurate glycemic profile can be created, and then used 
to fine tune the starting insulin pump doses. Insulin doses can be adjusted to account for 
patterns of glycemic excursion, therefore decreasing glycemic variability at the onset of 
insulin pump therapy, leading to a smoother transition between subcutaneous insulin 
injections and insulin pump therapy. No studies have been performed to date that have 
studied the use of CGM in this way.  
 
2.1 Primary Objective: 
- 
To determine whether the use of retrospective CGM data to inform starting doses 
prior to insulin pump initiation will: 
o Increase the percentage time within target blood glucose range (BG: 70-
180 mg/dL) 
2.2 Secondary Objectives: 
- 
To determine whether the use of retrospective CGM data to inform starting doses 
prior to insulin pump initiation will improve secondary outcomes: 
o Other measures of glycemic variability:  
▪ Mean BG and BG standard deviation 
▪ Mean amplitude of glycemic excursion. 
o Insulin doses:  
▪ Percentage change in total daily insulin dose 
▪ Percentage change in percent basal insulin used 
o Frequency of insulin dose adjustments:  
▪ Total number of insulin dose adjustments, 
▪ Total number of phone calls to clinic hotline 

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▪ Number of insulin dose adjustments made per phone call 
o Adverse effects: 
▪ Episodes of hypoglycemia  
▪ Episodes of diabetic ketoacidosis 
o Participant/parent satisfaction with transition to insulin pump therapy 
2.3 See sections 3.8 for details of measurement. 
 
3.0 
STUDY DESIGN  
 
This is a randomized controlled study of the use of continuous glucose monitoring prior 
to insulin pump initiation in children with type 1 diabetes mellitus. 
 
3.1 Participant Recruitment 
- 
Participants with type 1 diabetes from Children’s Hospital Los Angeles (CHLA), 
who have been referred by their primary endocrinologist for initiation of insulin 
pump therapy will be approached to participate in the study. 
- 
Recruitment would be in person or by telephone once referral to start insulin 
pump has been made. Nurses will receive referral, and contact investigator. 
Investigator will contact subjects either in person or by telephone. 
- 
Recruitment will take place in the CHLA Endocrinology and Diabetes clinic, at 
CHLA, Los Angeles, California. 
3.1.1 General criteria for starting pump  
- At CHLA, patients must be referred for pump initiation by their primary 
endocrinologist.  In general, to qualify for pump therapy, patients need 
to be testing blood glucoses levels 4-6 times daily, come consistently to 
scheduled follow-up appointments, and be willing to participate in 
comprehensive diabetes education. 
 
3.2 Inclusion/Exclusion Criteria 
- 
Listed in section 5.0. 
 
3.3 Consent: 
- 
Written consent will be obtained from the participant or participant’s parent(s) or 
guardian(s). Written assent will be obtained from the participant if less than 18 
years of age, but at least 7 years of age. Consent and assent will be obtained by 
the primary investigator. 
 
3.4 Securing Participant Identity 
- 
All participants will be assigned a sequential study identification (ID) number in 
the order of enrollment. The key linking study identification number to patient’s 
identifying information will be kept in a separate and secure location, and only be 
accessible to the investigator. All documents and data collection will use only the 
study identification number. 
 
3.5 Randomization 

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- 
Participants will be randomized to either have their CGM data used to inform 
initial pump doses, or standard insulin start using our clinic’s protocol. 
- 
See section 6.3 for details of randomization process. 
 
3.6 Study Procedures 
3.6.1 Initial visit – approximately 2±1 weeks prior to insulin pump initiation. This is 
a study visit, and not standard of care. Visit will last approximately 45 
minutes. 
3.6.1.1 Baseline characteristics will be collected on all participants 
enrolled by review of CHLA medical records and/or by completion 
of the CGM Participant Source Document and CGM Baseline 
Participant Information forms by participant/parent. A baseline 
physical exam will be performed. 
- 
See section 6.2 for details. 
3.6.1.2 All participants will have an iPro®2 (Medtronic MiniMed Inc., 
Northridge, CA, USA) placed by the investigator or a trained nurse in 
the CHLA diabetes clinic.  The iPro®2 will collect baseline data and 
glycemic trends on all participants.   
- 
Participants will be provided with log sheets (“CGM Participant 
Log Sheet”) and they will be instructed to check and  record blood 
glucose levels a minimum of four times a day (before meals and 
before bed), as well as record carbohydrate intake and significant 
activity or exercise.  
- 
Participants will wear the iPro®2 for 5 days.  
- 
The iPro®2 and log-sheets will then be mailed back to the 
investigator in a pre-paid envelop.  
3.6.1.3 Appointments for all future clinic encounters associated with the study 
will be made during the initial visit. 
 
3.6.2 iPro2 data will be downloaded by the investigator.  
- See section 4.1 for device details. 
 
3.6.3 Insulin pump doses determination 
- All participants will have insulin doses determined by “standard practice.” 
Standard practice for pump initiation in the CHLA clinic involves the 
following: 1-2 weeks prior to the scheduled pump class, the participant’s 
latest blood glucose log is reviewed by the participant’s diabetes nurse. A 
worksheet (“CGM Pump Dose Worksheet”) is then filled out by the nurse, 
which includes insulin daily totals (total rapid-acting insulin/day, total basal 
insulin/day, total daily dose (TDD), and total units of insulin/kilogram/day) 
and insulin pump calculations, including recognition of the honeymoon 
phase, the stage of puberty, the dawn phenomenon, and/or specific trends in 
high or low blood glucoses. In general, the total basal dose is reduced by 10-
20% of the current dose, with the use of multiple basal rates being at the 
discretion of the provider. In general, the correction scale is calculated by 
dividing 1800 by the TDD, and the insulin to carbohydrate ratio is 

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calculated by dividing 450 by the TDD. The proposed starting insulin 
regimen is reviewed and approved by the participant’s primary 
endocrinologist 
- For those participants randomized to have “informed” starting insulin pump 
doses (study group), the iPro®2 data will be made available only to the nurse 
or physician responsible for determining starting insulin pump doses, so that 
further dose adjustments may be made. 
- For participants randomized to “standard practice” (control group), iPro®2 
data will remain blinded until the end of the study and kept in a secure 
location. 
 
3.6.4 Initial Pump Class 
A. STANDARD OF CARE PROCEDURES 
 
1. All participants will attend a standardized CHLA pump initiation class. 
This is a 6-8 hour class held on a single day. The class is taught by a 
CHLA certified diabetes educator nurse. The class teaches basic pump 
features, clinical care on pump, identification and treatment of 
hypoglycemia and hyperglycemia, as well as sick-day management. 
2. Participants will have a hemoglobin A1c (HbA1c) collected. HbA1c 
will be determined by DCA Vantage Analyzer (Siemens, Malvern, PA). 
3. Participants will be instructed to perform blood glucose checks 
(capillary finger-stick on home meter) at least 6-8 times per day, 
including before meals, at bedtime, midnight and 3 a.m. Participants 
will be instructed to use the pump bolus calculator when giving an 
insulin bolus for correction and/or carbohydrates and to give insulin 
before eating. Participants will be instructed to keep a written log of 
blood glucose results, carbohydrates consumed, and insulin units given. 
B. RESEARCH PROCEDURES 
1. All participants will have the iPro2 placed by the investigator or trained 
nurse to collect data in the immediate period of transition to insulin 
pump. The device will be worn for 5 days and then mailed back to the 
investigator in a pre-paid envelope. Data will be downloaded and kept 
blinded and secure until data analysis is performed. 
2. Participants will be instructed to keep a written log ("CGM Participant 
Log Sheet") of blood glucose results, carbohydrates consumed, and 
insulin units given. 
 
3.6.5 Follow up 
- All participants will be asked to report blood glucoses to a CHLA diabetes 
nurse by phone on a daily basis for the first 4 days after starting on the 
insulin pump, and then once weekly for 5 weeks. This nurse will not have 
been previously involved with the initial dose determination and thus will 
remain blinded to the participant’s study group designation. Participants 
may also call at additional times, as needed. Insulin pump doses may be 
adjusted as needed, per routine, by CHLA diabetes nurses and/or physicians.  

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- Changes to pump settings will be documented in the electronic medical 
record, and the frequency, type of adjustments made, and ease of the phone 
call will be documented in a written log (“CGM Telephone Call Log”). 
 
3.6.6 Advanced Pump Class 
A. STANDARD OF CARE PROCEDURES 
1. All participants will attend a standardized advanced pump class, which 
will occur approximately 6±1 weeks after pump therapy initiation. 
2. Insulin pumps and blood glucose meters will be downloaded. 
3. Participants will have a hemoglobin A1c (HbA1c) collected.  
 
B. RESEARCH PROCEDURES  
1. All participants/their parents will be asked to complete a follow-up 
questionnaire (“Follow-up Participant/Parent Questionnaire”).  This 
questionnaire will take approximately 10 minutes to complete and will 
be administered at the end of the class. The questionnaire consists of 10 
questions, which will ask about brand of insulin pump, number of blood 
glucose checks per day, episodes of DKA (defined by emergency room 
visit or hospital admission), episodes of severe hypoglycemia (defined 
by loss of consciousness, coma, or seizure), and 6 questions regarding 
participant/parent satisfaction with the transition to insulin pump. 
2. All participants will have the iPro2 placed by the investigator or trained 
nurse and it will be worn for 5 days. The iPro2 will be mailed back to 
the investigator using a pre-paid envelope. Data will be downloaded 
and kept blinded and secure until data analysis is performed. 
 
3.6.7 Clinic Follow-up Visit 
A. STANDARD OF CARE PROCEDURES 
1.  All participants will have a follow up visit with their primary 
endocrinologists 3 months (±2 weeks) after starting on insulin pump 
therapy. 
2. All participants will have a hemoglobin A1C collected. 
 
B. RESEARCH PROCEDURES 
1. A brief, three question survey ("Provider Post-study Survey") will be 
given to diabetes nurses and physicians who were involved in using the 
CGM data to write initial insulin pump doses. An information sheet 
will be provided and verbal consent will be obtained. This survey will 
be distributed after all participants have completed the study. The 
survey will take approximately 5 minutes to complete. 
 
3.7 Subject retention: 
 
This study is of short duration, 3 months, and all visits after the initial visit are 
standard clinic visits for all patients who start insulin pump therapy (initial pump 
class, advanced pump class, and regular follow up with endocrinologist). This should 

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limit the number of participants lost to follow up. Participants will also be 
compensated with a $20 gift card at the 3 visits that an iPro2 is placed (Initial Visit, 
Initial Pump Class, Advanced Pump Class). 
 
3.8 Main Variables: 
 
3.8.1 Predictor variables: CGM data used to inform starting doses (yes/no). Blood 
glucose data provided by iPro®2 download. 
 
3.8.2 Outcome variables: 
 
o Primary Outcome: 
• Percentage time within target BG 
▪ Target BG: 70-180 mg/dL 
▪ The time spent within the target BG ranges indicated glycemic 
stability and adequate insulin dosing. Persistent blood glucose 
readings above or below this target range would necessitate a change 
in insulin pump doses. The goal of this study is to minimized 
glycemic variability and frequency of insulin pump dose 
adjustments. 
• The following data will be collected by iPro®2 (Medtronic Minimed, 
Inc., Northridge, CA, USA). This is a retrospective continuous 
glucose monitor, which will be placed per device instructions in the 
CHLA diabetes clinic by the investigator, be worn for 5 days, mailed 
back to the investigator, and then downloaded to collect data over 
that time period. This is an FDA approved device. Data will be 
collected via iPro®2 and downloaded at three times points, once prior 
to pump start, one week after pump start, and again 6 weeks after 
pump start. 
 
o Secondary Outcomes: 
• Other measures of glycemic variability. Data will also be collected 
by iPro®2 at three points in time, baseline, one week, and six weeks. 
▪ Mean blood glucose (BG), BG standard deviation 
▪ Mean Amplitude of Glycemic Excursion 
• Insulin Doses: The following data will be collected at two time 
points, 6 weeks apart. Data will be collected once prior to pump start 
and will be based on current parental report. Data will be collected a 
second time 6 weeks after pump start, and will be collected from 
data downloaded from the insulin pump. 
▪ Total daily insulin dose (TDD) 
▪ Percentage basal insulin 
• Changes to Insulin Doses: The following data will be collected over 
the 6 weeks following pump initiation. Data will be collected on 
standardized printed logs (“CGM Telephone Call Log”), by a 
diabetes nurse. 

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▪ Total number of insulin dose adjustments 
▪ Total number of phone calls to clinic hotline 
▪ The number of insulin dose adjustments made per phone call 
• Adverse Effects: The following data will be collected over the 6 
weeks following pump initiation. Data will be collected by patient 
interview and/or review of medical record and documented on 
source document (“CGM Participant Source Document”): 
▪ Episodes of severe hypoglycemia (loss of consciousness, seizure, 
coma) 
▪ Episodes of diabetic ketoacidosis (pH < 7.3, Bicarbonate < 15, 
hospital admission) 
• Glycemic Control: 
▪ Hemoglobin A1c collected at pump start, the advanced pump 
class at 6±1 weeks, and the 3-month follow visit at 3 months ±2 
weeks. 
• Patient/parent satisfaction: The following data will be collected via 
survey (Participant/Parent Questionnaire) given to 
patients/parents/guardians at the end of the advanced pump class. 
The survey will use a Likert Scale (strongly agree, agree, neutral, 
disagree, strongly disagree) to respond to six questions addressing 
patient/parent impressions of the process of transitioning to insulin 
pump therapy. 
• Nursing/physician Satisfaction: Data will be collected via the 
“Provider Post-study Survey,” which will be completed by nurses 
and physician directly involved with insulin pump dose decisions. 
Survey will be three questions, which will address utility and 
feasibility of using CGM data to write pump doses. 
 
 
4.0 
DEVICE INFORMATION 
 
4.1 
iPro®2 Professional Continuous Glucose Monitor (Medtronic MiniMed Inc., 
Northridge, CA, USA). 
The iPro®2 was approved by the FDA for all ages in 2011 for the continuous 
recording of blood glucose levels in persons with diabetes mellitus. The iPro®2 is 
composed of a disposable glucose sensor and the reusable digital recorder, which 
stores blood glucose data. A portion of the sensor is placed subcutaneous. The 
device measures blood glucose levels every 10 seconds and records blood glucose 
measurements every 5 minutes. Upon completion of data acquisition, the device is 
removed and the data from the digital recorder is uploaded to the CareLink iPro 
software program, which is a web-based, HIPAA compliant software program. 
 
4.2 
Supplier of the iPro®2: Medtronic MiniMed Inc. Concurrent with IRB 
submission, a formal request will be made to Medtronic for product support. This 
study will request that Medtronic provide the necessary iPro®2 devices, Sof-
Sensors, and related equipment including the Sen-serter for sensor placement, 

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Smart Dock device for uploading iPro®2 data, and CareLink Clinical Software 
(internet based). 
 
4.3 
Other supplies: Alcohol swabs. Tegaderm to secure the iPro2. 
 
 
5.0 
SELECTION AND WITHDRAWAL OF SUBJECTS 
 
5.1 
Inclusion Criteria: 
1. Males and Females aged 2-24 years  
2. Clinical diagnosis of Type 1 diabetes mellitus  
3. Duration of diabetes: At least 6 months  
- 
This will ensure some glycemic stability prior to study, and most children 
do not start on an insulin pump until about 6 months into their diagnosis. 
4. Basal/bolus insulin regimen using long-acting and rapid-acting insulin  
- 
This will provide a uniform method of insulin therapy. 
5. Willingness to perform at least 4 capillary blood glucose tests per day while 
wearing the iPro®2 
6. Willingness to wear the iPro®2 for 5 days continuously per insertion 
7. Participant agrees to comply with the study protocol requirements 
8. Informed Consent, Assent, HIPAA Authorization, and California 
Experimental Subject Bill of Rights signed by the participant and/or parent 
guardian 
 
5.2 
Exclusion Criteria: 
1. Comorbid conditions, including but not limited to cystic fibrosis, oncologic 
processes, other systemic diseases that may affect overall glycemic control 
2. Glucocorticoid use within 2 weeks of study enrollment 
3. Concurrent use of other medications that may affect glycemic control 
4. Prior CGM use in the past 6 months  
5. The participant has any skin abnormality (e.g. psoriasis, rash, staphylococcus 
infection) in the area of iPro®2 placement that has not been resolved at the 
time of enrollment and would inhibit the participant from wearing the iPro®2. 
6. Non-English speaking 
 
5.3 
Withdrawal Criteria:  
1. A participant has the right to discontinue participation in the study at any time 
without affecting future management and treatment. If a participant decides to 
withdraw from the study, they must notify the investigator immediately. It is 
the intention to replace subjects that do not complete the study in order to 
obtain complete data sets. 
2. An investigator has the right to discontinue a participant’s participation in the 
study at any time, and the participant may be within drawn from the study if:  
o There is deterioration in the participant’s signs/symptoms and/or the 
subject develops a disease or condition that in the opinion of the 

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investigator would compromise the subject’s safety in continuing the 
study 
o The participant develops a significant skin condition that prevents the 
participant from wearing the iPro®2. 
o The participant is unwilling or unable to comply with the required 
study procedures 
o The participant discontinues insulin pump therapy during the duration 
of the study 
 
 
6.0 
STRATIFICATION/DESCRIPTION FACTORS/RANDOMIZATION SCHEME 
 
6.1 Stratification Factors 
Participants will not be stratified or receive different treatments based on pretreatment 
clinical characteristics. 
6.2 Descriptive Factors 
At initial visit, baseline characteristics will be collected on all participants enrolled by 
review of CHLA medical records with documentation recorded on the participant’s 
source document and/or by completion of printed form (CGM Participant Source 
Document” and CGM Baseline Participant Information ”) by participant/parent:  
Age, gender, race/ethnicity, age at diagnosis of diabetes, diabetes 
diagnosis date, location of diabetes diagnosis, type of insulin used, 
baseline frequency of blood glucose monitoring, brand of blood glucose 
meter used, history of diabetic ketoacidosis (DKA) (requiring 
hospitalization), history of severe hypoglycemia (resulting in loss of 
consciousness, coma, or seizure), history of prior CGM use, last available 
hemoglobin A1c, average blood glucose level and standard deviation, total 
daily insulin dose (TDD) averaged over one week, percentage of daily 
basal insulin, insurance type, weight, height, body mass index (BMI), 
tanner stage. 
 
6.3 Randomization Plan  
Upon obtaining informed consent, subjects with be randomized to either have their 
CGM data used to inform initial pump doses in addition to standard of care (subject) 
or to receive standard of care alone (control). Simple 1:1 randomization will be used. 
A computer will randomly assign groups to a numbered list. The list will be kept 
secure in our clinic. As subjects are enrolled, clinic assistants not directly involved in 
the study will use the list to assign study groups in numeric order. The patient ID 
number will be logged on the list. Randomization will help reduce introduction of 
confounding variables.  
 
 
7.0 
CLINICAL AND LABORATORY EVALUATIONS AND STUDY CALENDAR 
 

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Parameter 
Initial  
Encounter 
Initial 
Pump  
Class 
Advanced 
Pump 
Class 
3-month 
Follow-up 
Targeted History & Directed Physical 
  Examination 
X 
 
 
 
Baseline Questionnaire 
X 
 
 
 
Follow-up Questionnaire 
 
 
X 
 
Hemoglobin A1c 
 
X 
X 
X 
iPro®2  placement 
X 
X 
X 
 
 
8.0 CRITERIA FOR EVALUATION AND ENDPOINT DEFINITIONS 
8.1 Study Endpoint 
The three-month follow-up visit with the participant’s primary endocrinologist 
will be the final visit of the study, after which no additional participation in the 
study will be required. Total duration of participation not to exceed 6 months. 
 
8.2 Study Closure 
The study will be closed after 40 enrolled participants have completed the study; 
specifically, all devices have been returned and uploaded, and all 3 month follow 
up visits with primary endocrinologists have been completed. 
 
9.0 DATA COLLECTION AND MONITORING 
9.1 Data Handling 
 
Data collection for this study will be captured using paper Case Report Forms 
(CRF). 
 
iPro®2, glucometer, and insulin pump data will be collected via device download. 
The iPro®2 data will be downloaded using Medtronic MiniMed CareLink 
Clinical. This system uses Secure Sockets Layers (SSL) technology, which 
encrypts all data it stores. Glucometer and insulin pump data will be downloaded 
using the approved software for each device. 
 
All data will be manually entered by the investigator into a password-protected, 
secure database. Microsoft Excel 2010 (Microsoft Office Professional Plus 2010; 
Microsoft Corporation) will be used. 
 
The investigator will ensure that all CFRs are completed and entered into the 
database promptly, completely, and accurately. 
 
10.0 
STATISTICAL CONSIDERATIONS 
 
The primary outcome of this randomized controlled study comparing youth with type 1 
diabetes starting on an insulin pump who either have their starting pump doses informed 
by CGM or by standard of care is the difference in pre/post change in mean percent time 
within target blood glucose range between the two groups.  A sample size of 40 

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participants will be enrolled and randomly allocated to the two groups.  Assuming a 20% 
dropout rate, a sample size of 16 per group will achieve the desired power of 80% to 
detect a 10% difference between groups, which corresponds to an effect size of 0.918.  A 
significance level of 0.05 is used throughout this design.  These calculations assume the 
standard deviation is approximately a quarter of the mean percent time within target 
blood glucose on both pre and post evaluation with correlation of 0.5 between pre and 
post measurements within each group.  Data will be analyzed using one-sided t tests.  A 
one-sided test was selected because this study is based on an existing technology, and 
only a finding of blood glucose improvement would be clinically relevant.  
 
 
 
11.0 
BIOHAZARD CONTAINMENT 
 
Biohazard materials will include sharps from the sensor insertion. Universal precautions 
will be followed at all times. All sharps will be disposed of in a sharps container. iPro®2 
digital recorder devices will be disinfected per manufacturer recommendations. 
 
12.0 
ETHICAL AND REGULATORY CONSIDERATIONS 
 
All institutional and Federal regulations concerning the Informed Consent form will be 
fulfilled.  The study will be conducted in adherence to ICH Good Clinical Practice. 
 
12.1 
Institutional Review Board 
This protocol, and any subsequent amendments to this protocol, the Informed 
Consent, Assent, HIPAA Authorization, California Experimental Subject Bill of 
Rights, Participant Information Sheets, and any form of participant recruitment 
information relating to the study will be approved by the responsible IRB. The 
study will not start until IRB approval has been granted. 
 
12.2 
Informed Consent/Assent 
Informed consent/assent will be obtained. Prior to entry into the study, the 
investigator will explain the purpose and duration of the study, requirements of 
the participant during the study, as well as potential risks involved with 
participation in this study. The IRB-approved written Informed Consent 
form/Assent form will be given to the participant/parent/guardian to read. The 
HIPAA Authorization will be also be given to the participant/parent/guardian. 
Participants/parents/guardians will be informed that the participation is voluntary. 
After all the subject’s/parent’s/guardian’s questions have been answered, and if 
participation in the study is desired, they will sign and date the Informed Consent, 
Assent, HIPAA Authorization, and California Experimental Subject Bill of 
Rights. Only after these documents have been properly completed can the study 
procedures commence. The consenting process will be documented in the 
participant’s study file. A copy of the signed Informed Consent, Assent, HIPAA 
Authorization, and California Experimental Subject Bill of Rights will be 
provided to the subject/parent/guardian. 

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12.3 
Potential Risks 
Serious adverse effects during past studies with continuous glucose monitoring 
were relatively rare. Usually side effects occurred with the glucose sensor and 
were often limited to reactions at the site of insertion on the skin, or related to 
adhesive tapes used to secure the device. These potential adverse effects include: 
 
o 
Skin irritation 
o 
Bruising 
o 
Redness 
o 
Bleeding 
o 
Discomfort 
o 
Tenderness 
o 
Pain 
o 
Rash 
o 
Infection 
o 
Irritation from tapes 
o 
Feeling faint or syncope with sensor insertion 
 
The possibility of infection is minimized by aseptic technique of sensor insertion. 
An insertion device (Sen-Serter) will be used to insert the sensor, which will 
ensure correct sensor placement and minimize discomfort. 
 
There is potential for adverse effects of hypo-/hyperglycemia related to the 
disease state of diabetes. A telephone number will be provided to all participants, 
which will be staffed 24 hours daily by a diabetes nurse or diabetes/endocrine 
physician. Participants will be calling this number daily for the first 4 days, and 
then weekly, to report blood glucose numbers, so insulin dose adjustments can be 
made before significant episodes of hypo-/hyperglycemia occur. Participants may 
also call this number as needed for any additional concerns. 
 
12.4 
Benefits 
 
There may be no direct benefit to the participant, but possible benefits of the 
participant electing to participate in the study include, but are not limited to:  
 
o 
Possible reduction in glycemic variability, swings in blood glucose values 
o 
Possible reduction in frequency of insulin pump dose adjustments 
o 
Possible reduction in hypo-/hyperglycemic episodes based on more 
accurate insulin doses. 
 
13.0 
REFERENCES 
1. 
Group DCaCTR. The effect of intensive treatment of diabetes on the development and 
progression of long-term complications in insulin-dependent diabetes mellitus. New 
England Journal of Medicine. 1993;329:977-986. 

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14 
 
2. 
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