Treatment for Type 1 Diabetes Mellitus

Phase-Based Progress Estimates
3
Effectiveness
3
Safety
SUNY Upstate, Syracuse, NY
Type 1 Diabetes Mellitus+2 More
Eligibility
65+
All Sexes
Eligible conditions
Select

Study Summary

This study is evaluating whether a new type of insulin pump may help improve blood sugar control.

See full description

Eligible Conditions

  • Type 1 Diabetes Mellitus

Treatment Effectiveness

Effectiveness Estimate

3 of 3
This is better than 93% of similar trials

Compared to trials

Study Objectives

This trial is evaluating whether Treatment will improve 1 primary outcome, 5 secondary outcomes, and 1 other outcome in patients with Type 1 Diabetes Mellitus. Measurement will happen over the course of 12 weeks for each arm of the crossover.

Week 12
CGM Measured Time <70 mg/dL
Glucose Control
HbA1c
Hyperglycemia
Hypoglycemia
Hypoglycemia Unawareness
Patient Reported Questionnaires

Trial Safety

Safety Estimate

3 of 3
This is better than 85% of similar trials

Compared to trials

Trial Design

3 Treatment Groups

Hybrid Closed Loop Control (HCL)
1 of 3
Sensor-Augmented Pump (SAP)
1 of 3
Predictive Low-Glucose Insulin Suspension (PLGS)
1 of 3
Active Control

This trial requires 90 total participants across 3 different treatment groups

This trial involves 3 different treatments. Treatment is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are in Phase 4 and have been shown to be safe and effective in humans.

Hybrid Closed Loop Control (HCL)
Device
The HCL intervention arm will utilize the Tandom t:slim X2 with Control-IQ Technology and Dexcom G6 CGM
Sensor-Augmented Pump (SAP)The SAP arm will utilize the Tandem t:slim X2 without HCL or PLGS features turned on and Dexcom G6 CGM
Predictive Low-Glucose Insulin Suspension (PLGS)
Device
The PLGS intervention arm will utilize the Tandom t:slim X2 with Basal-IQ Technology and Dexcom G6 CGM

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 12 weeks for each arm of the crossover
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly 12 weeks for each arm of the crossover for reporting.

Closest Location

SUNY Upstate - Syracuse, NY

Eligibility Criteria

This trial is for patients born any sex aged 65 and older. 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 of type 1 diabetes
Age ≥ 65 years old
T1D Duration of at least 1 year
HbA1c < 10.0% from point of care or local lab within the past 6 months
Insulin regimen involves basal/bolus insulin via insulin pump or multiple daily injections
Most recent GFR ≥ 30 ml/min/m^2 from local lab within the past 6 months
Willingness to use a rapid acting insulin compatible with the Tandem t:slim X2 pump (currently aspart and lispro; other rapid acting insulins likely to be approved for pump use prior to study initiation such as Fiasp)
Familiarity with and willingness to use a carbohydrate ratio for meal boluses
Willing to use study devices and automated insulin delivery features
Ability to download study devices at home or if not able to download at home willing to come into clinic to bring devices for download of data at visits and as needed for safety

Patient Q&A Section

Can diabetes, autoimmune be cured?

"Although autoimmune beta-cell failure is thought to occur early in autoimmune diabetes, as most patients have the disease for quite some time, the only real therapy for autoimmune diabetes is insulin pump therapy, at which the disease can be suppressed." - Anonymous Online Contributor

Unverified Answer

What are common treatments for diabetes, autoimmune?

"Diabetic patients typically have a higher rate of psychiatric complications, which may in part be related to glycemic control. Thus, effective therapy in this subset of patients is likely to influence outcome for both diabetes and depression. Copyright © 2015 John Wiley & Sons, Ltd. Diabetes mellitus type 2." - Anonymous Online Contributor

Unverified Answer

What causes diabetes, autoimmune?

"There is a strong association between autoimmunity and diabetes. However, one cannot infer from the presence of an autoimmune disease that diabetes is the result of a disorder in the autoimmune process." - Anonymous Online Contributor

Unverified Answer

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

"About 18.5 million Americans are likely to be affected by Diabetes in the year 2002, as most of them have no known risk factor. Of total number of Diabetes population, about 7.5 million are predicted to be affected in year 2020." - Anonymous Online Contributor

Unverified Answer

What are the signs of diabetes, autoimmune?

"As a group, those with diabetes display a greater prevalence of autoimmune diseases, such as diabetes autoantibodies and increased prevalence of insulin-dependent diabetes compared to normal subjects. In addition, there appears to be a marked increase of autoantibodies of diabetes in female." - Anonymous Online Contributor

Unverified Answer

What is diabetes, autoimmune?

"Diabetes with autoantibodies to insulin can be the first clinical presentation of diabetes with significant hyperglycemia and many patients with diabetes may be diagnosed at the time of presentation with diabetes and not first with DM1. Diabetics and healthy controls have an increased risk for islet cell autoantibodies, and hence a strong association exists with type 1 diabetes." - Anonymous Online Contributor

Unverified Answer

What are the common side effects of treatment?

"The common side effects of treatment [1], as measured by the Mayo Clinic, for [diabetes type 1](https://www.withpower.com/clinical-trials/diabetes-type-1) and autoimmune diabetes are (1) headaches [70%], [2] muscle aches [45%], and (3) joints, back, and muscle pain [46%]. The common side effects of treatment [3], as measured per the Mayo Clinic's database, for type 2 are [4] headaches [53%], [5] fatigue and (6) weight gain." - Anonymous Online Contributor

Unverified Answer

What is the primary cause of diabetes, autoimmune?

"Autoimmune and genetic causes of type 1 and type 2 diabetes, along with metabolic and lifestyle risk factors, make up the bulk of the risk for type 2 diabetes in our cohort. The metabolic effects of high BMI and poor diet may amplify the genetic risk. Genetic risk in those who are of Scandinavian ancestry is especially high, indicating that genetic factors are of major importance in the risk for type 2 diabetes in this population." - Anonymous Online Contributor

Unverified Answer

Who should consider clinical trials for diabetes, autoimmune?

"Clinicians from all backgrounds and all specialties and many subspecialties of medicine are prescribing therapies for diabetes, autoimmune conditions, and both of these conditions on a daily basis and are prescribing treatments for other conditions which are of clinical concern to patients. Given that these practitioners have a greater expertise than patients/guardians in the management of diabetes and autoimmune conditions, clinical trials for diabetes are likely to receive high levels of attention from clinical practitioners. However, there is a significant paucity of clinical trials for diabetes in general and specifically for autoimmune conditions in patients/guardians. Therefore, clinicians and investigators need to generate clinical trials. The need for clinical trials for diabetes and autoimmune indications is high and will rise in the coming years." - Anonymous Online Contributor

Unverified Answer

Is treatment typically used in combination with any other treatments?

"Most patients received drugs for a variety of reasons. Diabetes was the most frequently reported reason for use of other drugs. These drugs, which were not reported as being used typically in treatment, may influence the outcome of patients with diabetes in an adverse way." - Anonymous Online Contributor

Unverified Answer

What is the average age someone gets diabetes, autoimmune?

"Diabetes is becoming a problem in the older population. People with diabetes and autoimmune conditions had earlier diagnoses and more comorbidities than those with diabetes alone. The most common age of diagnosis was 65 years old in patients with diabetes alone, while those with autoimmune conditions had older diagnoses (58.5 years old) and more comorbidities (6.5 comorbidities). There is a need to educate people with diabetes and autoimmune conditions to help improve their earlier diagnosis." - Anonymous Online Contributor

Unverified Answer

How does treatment work?

"The majority of patients (64%) were responsive to one treatment regimen, suggesting that drug therapy is highly effective for long-term control of hyperglycemia. Long-term drug therapy also reduces the risk of developing diabetes and retinopathy in a substantial proportion of patients (29% and 23% respectively)." - Anonymous Online Contributor

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