Telemetric Glucose Data Acquisition During Initiation of Insulin Pump Therapy
|First Received Date ICMJE||February 23, 2006|
|Last Updated Date||March 18, 2011|
|Start Date ICMJE||March 2006|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures ICMJE
|Original Primary Outcome Measures ICMJE
|Change History||Complete list of historical versions of study NCT00297635 on ClinicalTrials.gov Archive Site|
|Current Secondary Outcome Measures ICMJE
|Original Secondary Outcome Measures ICMJE
|Current Other Outcome Measures ICMJE||Not Provided|
|Original Other Outcome Measures ICMJE||Not Provided|
|Brief Title ICMJE||Telemetric Glucose Data Acquisition During Initiation of Insulin Pump Therapy|
|Official Title ICMJE||Not Provided|
This study will help determine whether the use of a wireless glucose meter and and an internet-based automated diabetes management system to organize blood glucose values will help improve glucose control during the start of continuous subcutaneous insulin infusion therapy by an insulin pump device in patients with type 1 diabetes. Outcome measures to be determined include an assessment of glucose excursions, overall glucose control, health care team staff and patient time required and a satisfaction survey.
The study is focused on the following objectives:
Study Design and Description The study is designed to run for a period of 3 months of intensive management for each enrolled patient as they begin insulin pump therapy plus detailed glucose records beginning 4 weeks prior to the initiation of insulin pump therapy. Understanding relative glucose control following intensive management requires that we consider the results of the patient's HbA1c 3 months after conclusion of intensive management thus extending the time frame to 6 months.
Group A The Intervention Technology Group will be issued a GlucoMON device, a GlucoMON wall-mount recharging unit, a OneTouch Ultra glucose meter, paper logbook forms and test strips to support frequent testing for the 3 months following initiation of insulin pump therapy. The patient will be instructed on use and care of the GlucoMON as well as the OneTouch Ultra during a one-on-one session at the meeting immediately prior to initial delivery of insulin via the pump start.
Patients are also issued a specially configured low-cost 2way wireless email device which supports sending and receiving individual messages of up to 500 characters including the ability to send canned response options for easy data marking. Real-time messaging as part of the system is described in Addendum B. The intelligent logic behind the patient interaction is managed on a server in Diabetech's remote data center thus allowing for easy modification and centralized management of the patient interaction.
The TJU diabetes staff will initially review the patient record daily and will document the results of their review including any changes prescribed to the patient and the approximate amount of time involved in the handling of the encounter.
Group B (Control) The Conventional Technology Group will be issued a OneTouch Ultra glucose meter, paper logbook forms and test strips to support frequent testing for the 3 months following initiation of insulin pump therapy. The patient will be instructed on use and care of the OneTouch Ultra during a one-on-one session at the meeting to begin initial delivery of insulin via the pump start.
Patients will be instructed to complete the logbooks and fax daily to the TJU diabetes center. The TJU diabetes staff are available to review patient logs Monday thru Friday 8-5. Emergency after hours help is also available. The staff will initially review the patient logbook and will document the results of their review including any changes prescribed to the patient and the approximate amount of time involved in the handling of the encounter.
Data Analysis The data collected will include the patient's self-monitoring blood glucose (SMBG) test data, time-event logging annotations to the glucose tests, baseline and follow-up hemoglobin A1c test results, clinical events including hypoglycemia and hyperglycemia, and results of satisfaction questionnaires and time spent for analysis by the clinical staff for each patient.
The endpoints to be measured include frequent blood glucose testing, as is usual when a patient is initiating therapy with an insulin infusion pump, as well as HbA1c. The glucose levels will be analyzed with regard to the magnitude of glucose excursions and fluctuations and the mean daily glucose value over the 6 month period following the initiation of pump therapy.
The mean and standard deviation of each treatment group's (intervention and control) HbA1c will be calculated for each time point (0, 3, and 6 months post enrollment). Statistical differences in the HbA1c values between treatment groups at each time point and between different time points for each group will be sought. In addition, the change in HbA1c between time points (0 to 3, 3 to 6, and 0 to 6) will be calculated. The mean and standard deviation of these HbA1c changes will be calculated for each treatment group and analyzed for statistical significance.
SMBG data will be analyzed using glycemic control indices to compare the efficacy of both treatments. The following numerical indices will be used to describe the quality of metabolic control:
These indices will be computed using a moving window of data. The window will be stepped across each patient's SMBG data set through the intensive management period. Those data points that fall within the window will be used to compute the indices. The steps and widths of the window will be set at 1, 7, 14, and 28 days. For example, with a step and width of 7 days, each calculation of the M-value of a patient's SMBG data would encompass 7 days and there would be 12 different calculations for each week of the 3-month intensive management period. Statistical differences in the indices for a given window for each treatment group will be sought.
The amount of time taken by nurses and physicians to manage each patient will be tabulated. These data will be used to compute a cost associated with the management of the insulin pump start for each patient. The mean and standard deviation of this cost will be calculated for each treatment group and analyzed for a statistical significance.
A paired Student t-test or a one-way analysis of variance will be used to calculate a significant difference. A p value less than 0.05 will be considered statistically significant.
Standard Care Guidelines typically involve the diabetes center distributing a handbook of sorts to the patient upon diagnosis or as part of the initial visit to your center. In terms of ongoing care, patients are responsible for acquiring tools on their own for managing diabetes. In addition to insulin, patients must purchase their own glucose meters, test strips, lancing device, lancets, alcohol, fast acting sugar of some sort to treat low blood sugar, glucagon for severe hypoglycemia, etc... Depending on the form of insulin therapy, the patient must also purchase syringes or an insulin pump with disposable cartridges and infusion sets.
For the duration of the study, patients enrolled as Standard Care (Group B) will be given a glucose meter and test strips at no charge.
To facilitate communication of blood sugars and other diabetes relevant data with the center, the diabetes center shares one page of a standardized logbook form on 8.5" x 11" paper. It is the patient's responsibility to make copies of this form for their own use and also to deliver these completed forms to the diabetes center as needed. Methods for delivering this logbook include faxing (a patient must purchase their own fax machine or pay/borrow as well as any costs associated with fax transmission), US Mail (using their own envelope and postage) or hand deliver (using their own transportation).
Study Population As a patient elects to participate they will be assigned alternatively to either Group A or Group B beginning with assignment of the first patient enrolled into Group A.
Informed Consent Informed consent will be obtained from each participant.
Documentation Requirements All data and documentation will be held private and secure in compliance with HIPAA guidelines.
|Study Type ICMJE||Interventional|
|Study Phase||Phase 2|
|Study Design ICMJE||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Study Arm (s)||Not Provided|
|Publications *||Not Provided|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Withdrawn|
|Estimated Enrollment ICMJE||32|
|Estimated Completion Date||December 2007|
|Primary Completion Date||Not Provided|
|Eligibility Criteria ICMJE||
Patients must reside in the Philadelphia area and participate in regular in person visits to the Jefferson Diabetes Research Center. Patients must be at the stage of their treatment where they are going to initiate insulin infusion pump therapy. Patients must be at least 18 years of age before starting the protocol and must have never used an insulin pump before. Ideally, at least a few of the study participants will use English as a second language. Since the technology is capable of delivering messages to the wireless email device in several languages including Spanish and French, there is no English only requirement. Likewise, patients not capable of operating the wireless email device will be included since the GlucoMON device is specially designed to enable patient use without technology aptitude typical for personal computers and interactive wireless devices.
Patients living outside the Philadelphia area and those that are not immediately going to initiate insulin pump therapy wil be excluded. Patients unwilling to perform at least 4 blood glucose self-tests will be ineligible for participation in this study. Conventional guidelines for minimum self-care will apply including criteria for discontinuance of insulin pump therapy.
|Ages||18 Years and older|
|Accepts Healthy Volunteers||No|
|Contacts ICMJE||Contact information is only displayed when the study is recruiting subjects|
|Location Countries ICMJE||Not Provided|
|NCT Number ICMJE||NCT00297635|
|Other Study ID Numbers ICMJE||06C.07|
|Has Data Monitoring Committee||Not Provided|
|Responsible Party||Not Provided|
|Study Sponsor ICMJE||Thomas Jefferson University|
|Information Provided By||Thomas Jefferson University|
|Verification Date||March 2011|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP