The DreamTel project is designed to be carried out in 3 phases. In the first phase, the new technology will be introduced to volunteer subjects with uncontrolled type 2 diabetes. The second phase includes the development and implementation of a nurse directed medical management model for type 2 diabetes to allow a change in practice within the community. The goal is to allow primary care physicians in the community to refer patients to the Home Care team for initiation of insulin and diabetes intensification. This process involves health care provider education, the development of algorithm driven protocols based on clinical practice guidelines, patient education and disease measurement. In the third and final phase, subjects from the first phase who successfully used the device 80% of the time will be invited to participate in diabetes intensification with oversight from their primary care physicians.
Phase 1: Introduce the Bluetooth-enabled glucose meters into the community
Experimental Design. The target populations for the DreamTel study are participants with Type 2 diabetes and uncontrolled blood glucose levels with A1c levels in excess of 7.0%. Fifty subjects are targeted in the pilot study. Clients willing to participate in the program who have uncontrolled diabetes based on A1c levels above target will receive information on the use of the Bluetooth enabled device and will be consented into the project. They will then have the device installed into their home and receive training on its use from the Home Care team. Technical support is available from the sponsor. For the first phase, lab testing for A1c takes place at initiation of the device and after three months. Subjects will be identified by their primary care physician or by the Home Care team as needing diabetes intensification. Thus they will constitute a convenience sample. Subjects will be trained in the use of the glucose meters but do not have to be taking insulin on enrollment. All will be trained on the Bluetooth technology. The LifeStat service is an Integrated Communications Technology to capture physiological data that is transmitted via Bluetooth to an aggregation device located at the point of care. The aggregation device can be a cell phone but in the DreamTel study due to insufficient local coverage a Bluetooth/Analog modem with the local telephone will be used. The data is then forwarded to a secure hosting center by standard telephone network. The information is then accessed by users with the appropriate credentials through a care giver portal.
All subjects receiving the device will have a multi-disciplinary team diabetes assessment with standard diabetes screening tests including a baseline A1c level and agree to follow-up lab work on a three-month basis throughout the duration of the study. Each study subject will receive training in how to use the device and will be instructed on how to indicate that a test run was a validation test or another person's sample. Subjects will be instructed to use the results of the testing to manage their diabetes according to the education they received in light of food intake (or lack of), physical activity and whether medication had been taken. The client will be taught how to use the device and how to demonstrate that they were able to accurately use it. Data forwarded to the web server will be displayed through the portal graphically and include summary statistics. Data can also be printed by the patient's health care providers and could became part of the client's medical record. All consenting subjects will be asked to notify their primary care physicians that they are using the new device during regularly scheduled visits. Their physicians will also receive information packages from the Home Care team on the study and will be invited to participate in local Continuing Health Education programs on the study and the technology used. To determine whether the installation of the LifeStat device linked to the patient's telephone line impacts on blood glucose control, the A1c level at baseline (prior to its installation) will be compared to the three-month value. Typically A1c levels remain stable over short periods of time, rising over a period of years[45
To provide data on whether the blood glucose monitoring was before or after a meal, a teleprompt will be delivered to the client's phone. When a blood glucose result is received by the central server at SaskTel's central office in Saskatoon, Saskatchewan, an automatic teleprompt will call requesting a response as to the relationship between the test result and the last food intake. The teleprompt was developed in English and in Cree. Patients will be trained in its use. Each patient's impression of the teleprompt system will be addressed in questionnaires administered after the first 3 months of its use. Learning challenges will be collected as qualitative data to record the duration of time spent teaching and to record the challenges faced.
Another objective for the first three months of use is to compare data from three different sources; data transmitted by the device and stored on the web site, data stored on the device itself and the patient's log book, noting discordant values. Data is to be presented as the proportion of results recorded accurately. The frequency of monitoring based on data from the electronic output is to be assessed for the entire period.
Phase 2: Development of a Chronic Disease Management model for initiation of insulin in the community and intensification of blood glucose control
The medication algorithm is broken into stages and can be found in Additional File 1
: Initiation of metformin, initiation of sulphonylurea, initiation of thiozolidendiones and finally initiation of insulin followed by multidose insulin. A plan of management for diabetes intensification will be prepared for each patient based on their stage at their enrollment into phase 3, the treatment phase of the study. This plan will describe the dietary and lifestyle intervention they will receive as well as the planned stage for medication for the diabetes intensification. Prior to initiating each stage of medical therapy, a letter will be sent to the Primary Care physician including the results of the blood glucose monitoring. The letter will indicate the stage of diabetes intensification recommended and will include a standardized Home Care order set for that stage. The order sets were reviewed with some of the local primary care physicians during invited continuing education sessions about the DreamTel program. Once the Primary Care physician has reviewed this and signed the order set this stage of diabetes intensification will begin. When the stage of intensification of diabetes has been completed the Home Care team will notify the Primary Care physician. If the patient has achieved diabetes targets they will be maintained at this stage. If they have not achieved target then the orders for the next stage will be sent to the Primary Care physician and the patient assessed for the next stage.
Algorithms developed for diabetes management were developed based on clinical practice guidelines and reviewed with experts in diabetes management. For self monitoring of blood glucose[1
], the goal is a minimum of four times daily, two days per week for those on or starting insulin. Medication will be introduced in a stepped fashion for those on diet therapy alone starting with metformin followed by a sulphonylurea (gliclazide, as it is better tolerated in patients that develop kidney disease than others)[53
], thiazolidendiones (TZD's) will be added if sulphonylureas have failed. Pioglitazone (Actos) was chosen for use as it is a once daily preparation. This step was added prior to the controversy over rosiglitazone[54
]. The algorithm for diabetes intensification to be carried out by the Home Care team was incorporated into a standardized order form for the primary care physician to approve. The study team in partnership with the primary care physician will be responsible for assessing contraindications to the algorithms.
The initiation of insulin is often frightening for patients and a program of education and an algorithm for the introduction of insulin were developed. At all times, the primary care physician will be kept in the loop as part of a management model. After Home Care visits, reports on study letterhead will be faxed or mailed to the primary care physician. In addition, a system of graded alerts developed by the Home Care team including the use of the existing Provincial emergency Health Hotline and medical backup will be used in the study.
The goal of this phase of the program is to facilitate a change of practice to improve diabetes management over the long term. Physicians and the Home Care team need to become integrated and systems developed to do this. The hope is that following the study, patients who require diabetes intensification will be identified by the physician, the Home Care team and possibly by patients themselves. The Primary Care Physician would then initiate the process by signing a completed Home Care referral form for the initiation of intensification of diabetes management. This will initiate a visit by the Home Care team (nurse or dietitian).
Following three months with the device, if patients are testing at 80% of the target for measurement, they will be enrolled in the next phase of the program and receive diabetes intensification therapy. At this point, following the first phase, patients willing to participate in the program will received a physical exam and assessment of their current diabetes status and medications with a specialist and a determination on which part of the diabetes intensification algorithm they are in.
In the Province of Saskatchewan there is a billing code for the supervision of diabetes intensification. Educational sessions for the primary care physicians will include the rationale for the DreamTel study, a review of the protocol itself and information on this billing code and its appropriate use for the management of these patients. It is a goal of the DreamTel study that the Primary Care physicians will be able to continue to work with the Home Care team for the intensification of diabetes management after the project has been completed.
Home care referral forms were developed for the primary care physicians. It was planned that if the primary care physician did not want the Home Care team to do the intensification of diabetes management according to the planned algorithm that the subjects would be followed as a control. If the primary care physician directs the Home Care team to manage the patients in a similar fashion, only using different medications from the algorithm, based on patient specific factors, these patients will remain in the study. Referrals to the local diabetes education centre will be tracked if any occur. The commencement date for intensification will be recorded. Intensification is defined as increasing the dosage of a medication, adding another medication or initializing insulin according the algorithm for intensification.
For clients on oral anti-hyperglycemic agents, designated RN(s) who are part of the Home Care team will adjust these medications based on the protocol. Off-standard situations will be reviewed with one of the specialist study physicians.
The study endocrinologist (RL) will regularly review the medication adjustments for randomly selected clients as a quality control procedure. The Diabetes Educators will be able to review off-standard situations with him for advice and support. The web-based glucose readings will foster this process as the Diabetes Educator and endocrinologist will be able to view the client records and adjustment concurrently via the Internet. Time has been set aside for this on one weekday morning each week by teleconference. Development of the nurse protocol for the proposed study is based on the adaptation of the provincial template by an experienced Certified Diabetes Nurse Educator.
Phase 3: Achieve better control of blood glucose levels
Rationale. Based on the success of the DREAM study where a chronic disease management model resulted in improved blood pressure control[7
], the DreamTel study hopes to demonstrate that a chonic disease management program can improve glycemic control in First Nations People with diabetes.
Experimental Design: The main intervention will be applied to the treatment group and will consist of diabetes management intensification including a stepped drug protocol algorithm for pharmacologic management of blood glucose including the addition of insulin when indicated, diet and lifestyle education, with the long term goal of achieving A1c levels of ≤ 7.0%. (see Additional File 1
The study is designed as a pilot consisting of fifty subjects. Subjects entering this phase of the study will have type 2 diabetes and will have used the LifeStat blood glucose monitoring device for 3 months. Subjects will have completed at least 80% of all recommended glucose meters readings and will have been agreeable to intensification of diabetes according to the treatment algorithm. Diabetes intensification includes as needed, the initiation of oral hypoglycemic agents, the addition or increase of dosage of oral hypoglycemic agents and the initiation and dose titration of insulin. A1c levels will be drawn on a three-monthly basis. If fewer subjects than anticipated make it through phase 1 and are eligible for phase 3, additional subjects will not be recruited. As this is a pilot study, the reasons that fewer subjects than expected are able or willing to enroll into phase three will be explored.
All patient information specific to diabetes management from each Home Care visit to implement the intensification protocols will be forwarded to the patient's family physician. Follow-up with the patient's primary care physician will be requested by the Home Care team with each medication change to ensure that they are aware of the patient's new treatment status, and that it corresponds to their desired treatment goals for that patient. The Home Care team will be responsible for attempting to maintain ongoing contact with their clients if their clients accept that contact. Participants will be provided with snacks and meals as well as health-promotion materials part of current protocols. Additionally the study sponsor provided gifts such as t-shirts and mugs for study visits to see the study investigators, part of preexisting health promotional activities.
The initial assessment will include lab testing and historical information to address risk factors for cardiovascular-renal disease. The results of all testing will be forwarded to the primary care physician; subsequently, protocol-driven therapy for blood sugar control will begin. Medication doses and compliance will be closely monitored and prescriptions will be adjusted, as necessary. In the DREAM3 study, 45% of subjects had A1c levels ≥ 8.0%[7
This investigation will be conducted in North Battleford, Saskatchewan. The DreamTel nurse coordinator will be based at the Battlefords Tribal Council Health Care services in North Battleford and will coordinate all aspects of the study under the supervision of Joan Wentworth. Dr. Lewanczuk will be responsible for the diabetes management algorithm. Data collection and management will be coordinated by Dr. Sheldon Tobe. A data clinical research assistant, based in Toronto, will be responsible for the monitoring, data collection and data entry. Statistical analysis will be performed at the Institute for Clinical Evaluation (ICES) in Toronto.
Type 2 Diabetes with baseline A1c ≥ 7.0% on diet or medical therapy with no history of diabetic ketoacidosis. Patients must be greater than or equal to 18 years of age. Written informed consent must be obtained prior to admission to this study.
Analytic procedures and sample size calculation
This is a pilot study that will compare, in a before and after methodology, the intervention of diabetes intensification on the primary response variable of blood glucose level (A1c) measured at baseline and at 6 months. The pilot study will also determine the ability to enroll patients into the study and determine how many are able to maintain an 80% adherence rate to the use of the glucose meter four times daily at least twice weekly. This is also a goal of phase 3 of this study. See Additional file 2
for statistical design considerations.
Initiation of Diabetic Medication Treatment: The goal of Intensification therapy is A1c <7.0%. Patients in the usual care arm will continue to see their primary care physicians. Therapy in the treatment group will be initiated with the goal to bring the fasting plasma glucose ≤ 6 mmol/L and in insulin treated patients, pre-meal glucose concentrations of 4–7 mmol/L.
Safety and Interim Monitoring. Drug therapy may be interrupted at any time during the trial if further evidence for more appropriate drug therapy becomes available. All drugs used in this trial are available in regular clinical practice. Women of child-bearing potential must have a negative urine pregnancy test prior to receiving study medication. Patients will be asked for adverse events from the last visit related to hypoglycemic episodes and these data recorded. In the UKPDS 33 study the rates of major hypoglycemic episodes per year were 0.7% with conventional treatment, 1.0% with chlorpropamide, 1.4% with glibenclamide, and 1.8% with insulin [48
]. Severe hypoglycemia defined as needing the assistance of another person, or coma, will be tracked, as will diary-recorded instances.
Case report forms, confidentiality, data security and monitoring. Case report forms will be completed by the study nurse in Saskatchewan and faxed to the coordinating centre in Toronto after all patient identifiers have been removed; data monitoring will be completed on each visit. The original forms will be kept on file at the Battlefords Tribal Council Indian Health Services. All data is owned in collaboration with the Battlefords Tribal Council Indian Health Services. All work for publication from this data will be shared with this group prior to submission and requests for aggregate data will be honored as quickly as resources permit. At all times the Investigators have the final responsibility for the accuracy and authenticity of all clinical data entered on the CRF's. The study will be conducted according to the Battlefords Tribal Council Indian Health Services Ethical Guidelines for Research and the principles of Ownership, Control, Access, Possession[55
]. The Data Coordinator/Monitor will conduct site visits four times annually at a mutually agreed upon time for the purpose of auditing the study. The local investigator and clinical coordinator agree to allow the monitoring of the clinical supplies storage area and study documentation.
Approvals. The Battlefords Tribal Council Indian Health Services Inc has passed a Tribal Council Resolution approving the implementation of the DreamTel study. Ethics approval has been obtained from the Sunnybrook Health Sciences Centre and the BTC Research Ethics Boards. (see Additional file 3
Study subjects will be followed from study entry until study completion (18 month study protocol from the start of phase 1). The primary outcome of this phase of the study is the A1c after 6 months. A1c results collected beyond this will be analyzed if there are sufficient subjects. Subjects may withdraw from the study at any time. Subjects who refuse or are unable to adopt the recommendations of diabetes intensification management will be followed in an intent-to-treat fashion.