TANDEM Diabetes Care Control-IQ Tandem Source User Guide
- June 25, 2024
- TANDEM Diabetes Care
Table of Contents
TANDEM Diabetes Care Control-IQ Tandem Source
Product Information
Specifications:
- Technology: Control-IQ
- Data Source: Tandem Source
- Insulin On Board: 2.2 u
- Bolus: 0.80 u
- CGM Data Provider: [CGM Provider]
Product Usage Instructions
1. Uploading Pump Data:
Visit source.tandemdiabetes.com to upload pump data or view reports.
2. Saving and Printing Reports:
Select Overview, Daily Timeline, and Pump Settings at the last upload, and choose a two-week date range.
3. Following the Worksheet:
Get step-by-step guidance on clinical assessment, user education, and insulin dose adjustments.
4. Assessing Glycemic Targets:
- Check if glycemic targets are being met.
- Verify the usage of Control-IQ technology.
- Identify patterns of hypoglycemia and/or hyperglycemia.
5. Assessing Insulin Delivery:
Check for Level 2 hypoglycemia using Time Below Range (TBR) data.
FAQ
- Q: How often should I upload pump data?
- A: It is recommended to upload pump data regularly, at least once every two weeks, for optimal monitoring and adjustments.
- Q: Can I adjust the Control-IQ technology settings?
- A: Yes, you can make adjustments to the Control-IQ settings based on your healthcare provider’s recommendations and your individual needs.
Instructions for Use
-
View User’s Pump Data
Visit source.tandemdiabetes.com and upload pump data or view reports. -
Save and Print Reports
Select Overview, Daily Timeline, and Pump Settings at last upload, and select a two week date range -
Follow the Worksheet
Get step-by-step guidance on clinical assessment, user education, and insulin dose adjustments.
Patterns
Reasons
Identify the predominant causes of a hypoglycemia or hyperglycemia pattern
Is a hypoglycemia pattern occurring?
- Fasting/overnight?
- After meal bolus? (1-3 hours after)
- Following hyperglycemia events?
- During or after exercise?
Is a hyperglycemia pattern occurring?
- Fasting/overnight?
- After meal bolus? (1-3 hours after)
- Following hypoglycemia events?
Solutions
Education
Adjust insulin pump settings
Consider calculating pump settings based on Total Daily Insulin (TDI) if the user not reaching \desired TIR or has multiple timed settings within their profile (potentially from users transitioning from prior pump therapy). Can use “Calculating \Pump Settings” table on the back for settings recommendations.
Adjustable parameters
Basal rates, carb ratios, and correction factors can be modified to patient needs. Target range values are preset to 112.5-160 mg/dL if Control-IQ technology is enabled, or modified to 112.5-120 mg/dL during Sleep Activity and 140-160 mg/dL during Exercise Activity. \Correction factor directly impacts how Control-IQ technology automates insulin delivery, including bolus delivery. Studies show a more aggressive correction factor is associated with higher time in range with negligible impact to hypoglycemia.3
Personal Profiles
Up to six Personal Profiles can be created to personalize anticipated changes in insulin requirements.
Infusion Site Tips
When in doubt, change it out:
✓ If unexplained hyperglycemia persists (i.e., >250 mg/dL for >90 minutes)
- Correct by injection
- Change infusion set, site, and cartridge
- Check for ketones
Other times to change infusion set:
- If wetness (possible \leaking) or redness/ swelling (possible infection) at site
- If not changed within 2-3 days
- If insulin or infusion set is expired
- Rotate site often to avoid scar tissue/ lipohypertrophy
- If experiencing repeated infusion site problems, \try a different cannula length or infusion set
Disconnecting:
- If disconnecting from the pump, suspend insulin so Control-IQ technology calculates insulin on\ board accurately and continue to monitor glucose
- If disconnecting for 1-4 hours, deliver bolus if hyperglycemia occurs. Reduce amount for activity if neccessary.
- If disconnecting for more than four hours, have injections available as a backup plan
- Always disconnect from site on body, not the tubing connector
Calculating Pump Settings
Responsible Use of Control-IQ Technology
Even with advanced systems such as the t:slim X2 insulin pump with Control-IQ technology, users are still responsible for actively managing their diabetes. Control-IQ technology does not prevent all high and low blood glucose events. The system is designed to help reduce glucose variability, but it requires that users accurately input information, such as meals and periods of sleep or exercise. Control-IQ technology will not function as intended unless all system components, including CGM, infusion sets and pump cartridges, are used as instructed. Importantly, the system cannot adjust insulin dosing if the pump is not receiving CGM readings. Because there are situations and emergencies that the system may not be capable of identifying or addressing, users should always pay attention to their symptoms and treat them accordingly
Content adapted with permission from the PANTHER Program,® University of Colorado, pantherprogram.org
- If glucose values are predicted to be above 180 mg/dL, Control-IQ technology calculates a correction bolus using the Personal Profile settings and a target of 110 mg/dL and delivers 60% of that value.
References: 1. Diabetes Technology: Standards of Care in Diabetes – 2024. Diabetes Care. 2024;47(Suppl. 1):S126-S144. doi: 10.2337/dc24-S007. 2. Walsh J, Roberts R. Pumping Insulin: Everything for Success on an Insulin Pump and CGM. 6th ed. San Diego, CA: Torrey Pines Press; 2016. 3. Messer LH, Breton M. Therapy Settings Associated with Optimal Outcomes for t: slim X2 with Control- IQ Technology in Real World Clinical Care. Diabetes Technol Ther. 2023;25(12):877-882. doi: 10.1089/dia.2023.0308 4. Grunberger G, Abelseth JM, Bailey TS, et al. Consensus Statement by the American Association of Clinical Endocrinologists/American College of Endocrinology Insulin Pump Management Task Force. Endocr Pract. 2014;20(5):463-489. doi: 10.4158/EP14145.PS 5. Hinnen D, DeGroot J. Therapy Intensification: Technology and Pain Management. In: The Art and Science of Diabetes Care and Education.5th ed. Chicago: Association of Diabetes Care and Education Specialists; 2021:592-593.
Important Safety Information: RX ONLY. The t:slim X2 pump and Control-IQ technology are intended for single-patient use. The t:slim X2 pump and Control-IQ technology are indicated for use with NovoLog or Humalog U-100 insulin. t:slim X2 insulin pump: The t:slim X2 insulin pump with interoperable technology is intended for the subcutaneous delivery of insulin, at set and variable rates, for the management of diabetes mellitus in people requiring insulin. The pump is able to reliably and securely communicate with compatible, digitally connected devices, including automated insulin dosing software, to receive, execute, and confirm commands from these devices. The pump is indicated for use in individuals 6 years of age and greater. Control- IQ technology: Control-IQ technology is intended for use with compatible integrated continuous glucose monitors (iCGM, sold separately) and alternate controller-enabled (ACE) pumps to automatically increase, decrease, and suspend delivery of basal insulin based on iCGM readings and predicted glucose values. It can also deliver correction boluses when the glucose value is predicted to exceed a predefined threshold. Control-IQ technology is intended for the management of Type 1 diabetes mellitus in persons 6 years of age and greater.
WARNING : Control-IQ technology should not be used by anyone under the age of 6 years old. It should also not be used in patients who require less than 10 units of insulin per day or who weigh less than 55 pounds.
Control-IQ technology is not indicated for use in pregnant women, people on dialysis, or critically ill patients. Do not use Control-IQ technology if using hydroxyurea. Users of the t:slim X2 pump and Control-IQ technology must: use the insulin pump, CGM, and all other system components in accordance with their respective instructions for use; test blood glucose levels as recommended by their healthcare provider; demonstrate adequate carb-counting skills; maintain sufficient diabetes self-care skills; see healthcare provider(s) regularly; and have adequate vision and/or hearing to recognize all functions of the pump, including alerts, alarms, and reminders. The t:slim X2 pump must be removed before MRI, CT, or diathermy treatment. Visit tandemdiabetes.com/safetyinfo for additional important safety information. The Tandem Source platform is intended for use by individuals with diabetes mellitus who use Tandem Diabetes Care insulin pumps, their caregivers, and their healthcare providers in home and clinical settings. The Tandem Source platform supports diabetes management through the display and analysis of information uploaded from Tandem insulin pumps. © 2024 Tandem Diabetes Care, Inc. All rights reserved. Tandem Diabetes Care, the Tandem logo, Control-IQ, Tandem Source, and t:slim X2 are either registered trademarks or trademarks of Tandem Diabetes Care, Inc. in the United States and/or other countries. All third-party marks are the property of their respective owners. ML-1012028_C
Contact
References
- Diabetes Technology. Deciphered. | PANTHER Program
- t:connect Portal
- Important Safety Information - Tandem Insulin Pumps