Tandem t:slim X2 with Control-IQ Technology Pro for Diabetes Mellitus

Phase-Based Estimates
1
Effectiveness
1
Safety
Stanford University, Stanford, CA
Diabetes Mellitus+2 More
Tandem t:slim X2 with Control-IQ Technology Pro - Device
Eligibility
< 18
All Sexes
Eligible conditions
Diabetes Mellitus

Study Summary

This study is evaluating whether an automated insulin delivery system may help improve blood glucose control in young children with type 1 diabetes.

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Eligible Conditions

  • Diabetes Mellitus
  • Diabetes, Autoimmune
  • Diabetes Mellitus, Type 1
  • Type 1 Diabetes Mellitus

Treatment Effectiveness

Study Objectives

This trial is evaluating whether Tandem t:slim X2 with Control-IQ Technology Pro will improve 1 primary outcome, 5 secondary outcomes, and 46 other outcomes in patients with Diabetes Mellitus. Measurement will happen over the course of 2 hours.

13 weeks
Adverse device effects (ADE)
Any adverse event rate
Body Mass Index (BMI)
CGM-measured mean glucose
CGM-measured percent <60 mg/dL
CGM-measured percent above 250 mg/dL
CGM-measured percent below 54 mg/dL
CGM-measured percent below 70 mg/dL
Fear of Hypoglycemia Survey for Parents (HFS-P) - total score, 2 subscales and 4 factor scores
HbA1c <7.0 percent at 13 weeks
HbA1c <7.5 percent at 13 weeks
HbA1c absolute improvement from baseline to 13 weeks >1.0 percent or HbA1c <7.0 percent at 13 weeks
HbA1c at 13 weeks
HbA1c improvement from baseline to 13 weeks >0.5 percent
HbA1c improvement from baseline to 13 weeks >1.0 percent
HbA1c relative improvement from baseline to 13 weeks >10 percent
INSPIRE Survey (Insulin Delivery Systems: Perceptions, Ideas, Reflections and Expectations) (CLC arm only)
Number of DKA events and DKA event rate per 100 person-years
Number of SH events and SH event rate per 100 person-years
Number of calendar days with any ketone level ≥1.0 mmol/L (if ≥5 total calendar days combined)
Number of other serious adverse events
Pediatric Inventory for Parents (PIP) 2 domains each with a total score and 4 subscales for (5x2=10 difference scores)
PedsQL Diabetes Module - total score and 5 subscales
Percentage of total insulin delivered via basal
Pittsburgh Sleep Quality Index (PSQI) global score
Serious adverse device events (SADE)
Time in Range
Total daily insulin (units/kg)
Unanticipated adverse device effects (UADE)
Weight
Worsening of HbA1c from baseline to 13 weeks by >0.5 percent
glucose variability measured with the coefficient of variation (CV)
glucose variability measured with the standard deviation (SD)
high blood glucose index (HBGI)*
hyperglycemic events (defined as at least 90 consecutive minutes >300 mg/dL)
hypoglycemic events (defined as at least 15 consecutive minutes <54 mg/dL)
low blood glucose index (LBGI)*
percent >300 mg/dL
percent above 180 mg/dL
percent in range 70-140 mg/dL
percent in range 70-180 mg/dL improvement from baseline to 13 weeks ≥10 percent
percent in range 70-180 mg/dL improvement from baseline to 13 weeks ≥5 percent
percent time in range 70-180 mg/dL >70 percent and percent time <70 mg/dL <4 percent
2 hours
CGM-measured % <54 mg/dL during the two hours immediately following the start of exercise for each exercise-related challenge
CGM-measured % <70 mg/dL during the two hours immediately following the start of exercise for each exercise-related challenge
4 hours
CGM-measured % >180 mg/dL during the four hours following the announced meal, or until the next meal bolus is given, for the missed meal bolus challenge
CGM-measured % >300 mg/dL during the four hours following the announced meal, or until the next meal bolus is given, for the missed meal bolus challenge
8 hours
CGM-measured % <54 mg/dL overnight (all challenge types)
CGM-measured % <70 mg/dL overnight (all challenge types)
CGM-measured % >180 mg/dL overnight (all challenge types)
Hour 24
Number of SH events during, immediately after and overnight from the study challenges
Number of adverse events during, immediately after and overnight from the study challenges

Trial Safety

Trial Design

2 Treatment Groups

SC Group
CLC Group

This trial requires 109 total participants across 2 different treatment groups

This trial involves 2 different treatments. Tandem T:slim X2 With Control-IQ Technology Pro is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are not being studied for commercial purposes.

CLC GroupParticipants who skip or successfully complete the run-in will be randomly assigned 2:1 to the use of closed-loop control (CLC group) system using Tandem t:slim X2 with Control-IQ Technology vs Standard of Care (SC group) for 3 weeks. Participants randomized to the intervention group will use the Tandem t:slim X2 with Control-IQ Technology v1.0 during the first 13 weeks of the study (RCT phase, weeks 1-13) and then use Tandem t:slim X2 insulin pump with Control-IQ Technology v1.5 for the remaining 13 weeks of the study (extension phase, weeks 14-26).
SC GroupParticipants who skip or successfully complete the run-in will be randomly assigned 2:1 to the use of closed-loop control (CLC group) system using Tandem t:slim X2 with Control-IQ Technology vs Standard of Care (SC group) for 3 weeks. Participants randomized to the SC group will use their existing insulin therapy in conjunction with study Dexcom G6 CGM during the first 13 weeks of the study (RCT phase, weeks 1-13). The SC group will then transition to using the Tandem t:slim X2 insulin pump with Control-IQ Technology v1.5 and study Dexcom G6 CGM for the remaining 13 weeks of the study (weeks 14-26).

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: up to 24 hour period
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly up to 24 hour period for reporting.

Who is running the study

Principal Investigator
M. B.
Marc Breton, Principal Investigator
University of Virginia

Closest Location

Stanford University - Stanford, CA

Eligibility Criteria

This trial is for patients born any sex aged 18 and younger. There are 10 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Clinical diagnosis, based on investigator assessment, of type 1 diabetes for at least 6 months and using insulin for at least 6 months
Investigator has confidence that the parent can successfully operate all study devices and is capable of adhering to the protocol
Total daily insulin dose (TDD) at least 5 U/day
Familiarity and use of a carbohydrate ratio for meal boluses.
Age ≥2 and <6 years old
Living with one or more parent/legal guardian knowledgeable about emergency procedures for severe hypoglycemia and able to contact emergency services and study staff.
Willingness to switch to lispro (Humalog) or aspart (Novolog) if not using already, and to use no other insulin besides lispro (Humalog) or aspart (Novolog) during the study for participants using a study-provided Tandem pump during the study.
• Study will not be providing insulin; therefore, participants will need to have access to either lispro or aspart
Body weight at least 20 lbs.
Willingness not to start any new non-insulin glucose-lowering agent during the course of the trial (see section 2.3)

Patient Q&A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does diabetes mellitus run in families?

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The study found little evidence of an increased prevalence of type 2 DM with or without NIDDM in the same members of a family, which supports the hypothesis of environmental and/or genetic contributions.

Unverified Answer

What are the signs of diabetes mellitus?

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Diabetes is a disease of diabetes mellitus. The most well-known signs are those that are the result of either diabetes itself or of diabetes-associated complications such as blindness, ischemic heart disease, or nephropathy.\n

Unverified Answer

What are common treatments for diabetes mellitus?

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Diabetes is often treated with CBT, but medications also play a major role. Self-management education is most often used in conjunction with other treatments to educate and empower patients. Diabetes is associated with a number of comorbidities; however, the underlying causes of these comorbidities are often unclear. In individuals with diabetes mellitus who have more severe, long-term comorbidities/complications, such as those with diabetes and hypertension, it is important that patients receive appropriate treatment. It is also important that patients have frequent assessments to monitor progress and to take action, especially with regards to blood pressure.

Unverified Answer

Can diabetes mellitus be cured?

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In a recent study, findings of this study could be extrapolated to other countries with different healthcare systems. Diabetes mellitus is undoubtedly a major public health problem, but if all persons with diabetes were cured, the cost to the nation would be very small. In a recent study, findings has given us some data on the likelihood that if we were to cure all persons with diabetes we could achieve a significant reduction in the incidence of cardiovascular disease without a significant reduction in life expectancy of any of us, even though the chances of cure are very small.

Unverified Answer

What is diabetes mellitus?

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Diabetes mellitus is the most common disease of unknown etiology in patients who received an allogeneic liver graft. When patients were categorized by age, nonalcoholic DM seemed to be more common in young patients (< 45 years), while HNF1A-MODY seems to be more prevalent in older adults (45 to 69 years). In contrast, the prevalence of HNF1A-MODY was high in patients who received their whole-body cadaver graft, and this may have resulted in the exclusion of the nondiabetic graft recipients.

Unverified Answer

How many people get diabetes mellitus a year in the United States?

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About 45 million Americans have been diagnosed with diabetes, making it the most common chronic disease worldwide. Most newly diagnosed Americans have type 2 diabetes. New cases of diabetes have an estimated five-year economic impact of $117 billion. Diabetes is the eighth leading cause of death in the US.

Unverified Answer

What causes diabetes mellitus?

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Approximately 2/3 of diabetes cases are not caused by identifiable risk factors, and the remainder are caused by lifestyle and genetic factors. The risk for developing diabetes increases as the body ages.

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What are the common side effects of tandem t:slim x2 with control-iq technology pro?

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Tandem t:slim x2 with control-iq system as well as other obesity treatment devices were acceptable by obese patients due to the small number of adverse events reported.

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What is the latest research for diabetes mellitus?

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Diabetes mellitus is a major health problem not only in Canada, but worldwide. Research remains a significant undertaking in this field. The evidence has improved but the quality of research is still variable and needs to be improved. This will need to happen, for instance, by improving the quality of design of clinical trials, enhancing the study duration, increasing the number of centres, and enhancing collaborations between industry and research organisations.

Unverified Answer

Have there been other clinical trials involving tandem t:slim x2 with control-iq technology pro?

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While there are other recent studies that have shown positive results towards a more efficient type of glucose monitoring than a CGMS, there have been no previous published studies that have shown a similar type of results pertaining to a single device. As such, no conclusions can be drawn for a conclusion and a conclusion can not be drawn with regards to the current results. While, it would appear that it is a positive and beneficial product, more empirical studies need to be conducted to corroborate, if possible, the findings of T2T2X2iQ.

Unverified Answer

What is the primary cause of diabetes mellitus?

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Type 2 diabetes is one of the most common types of diabetes with an incidence of approximately 5% of the global population. Despite this, it is commonly overlooked as a primary cause of diabetes. In the United States, approximately 95% of diabetes cases can be traced back to obesity, a condition of excessive fat accumulation that causes insulin resistance which is an important aspect of the etiology of type 2 diabetes.

Unverified Answer

Has tandem t:slim x2 with control-iq technology pro proven to be more effective than a placebo?

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In patients with a >/=10.0% HbA1c>/=6.0%, treatment with tandem X2® Pro and an HbA1c goal>/=6.1% is associated with a statistically significant reduction in HbA1c after a 4-month treatment duration compared with a placebo or a monotherapy treatment of the same magnitude. Compared with monotherapy, X2® Pro may be most effective in reducing HbA1c. This clinical trial has limitations, including limited enrollment and short study duration and also is open-label. The open label trial is ongoing and in a new stage. Clinically significant findings are awaited.

Unverified Answer
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