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A Trial Evaluating Automated Insulin Delivery Technologies on Hypoglycemia and Quality of Life in Older Adults With Type 1 Diabetes

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ClinicalTrials.gov Identifier: NCT04016662
Recruitment Status : Not yet recruiting
First Posted : July 11, 2019
Last Update Posted : July 16, 2019
Sponsor:
Collaborators:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
DexCom, Inc.
Tandem
University of Minnesota - Advanced Research and Diagnostic Laboratory
Mayo Clinic
University of Pennsylvania
AdventHealth Diabetes Institute
Washington State University
Information provided by (Responsible Party):
Jaeb Center for Health Research

Brief Summary:
A 28-week crossover study to compare whether closed-loop control (CLC) or predictive low-glucose suspend (PLGS) can reduce hypoglycemia compared with sensor-augmented pump therapy (SAP) in older adults age at least 65 years with type 1 diabetes (T1D).

Condition or disease Intervention/treatment Phase
Type 1 Diabetes Mellitus Device: Dexcom G6 CGM Not Applicable

Detailed Description:

Automated insulin delivery (AID) technologies hold the promise of optimizing glycemic control and reducing the burden of diabetes care for patients with Type 1 Diabetes (T1D). However, clinical trials of lower burden AID technologies have not included older adults in sufficient numbers to allow for focused evaluation of efficacy and quality of life (QOL) impacts that may differ from those observed in younger age groups. Most notably, primary endpoints have focused on reducing hyperglycemia, while avoidance of hypoglycemia is of upmost concern for older adults with T1D. T1D Exchange clinic registry data have shown severe hypoglycemia (SH) occurs more commonly in older adults with longstanding T1D than in younger individuals with events occurring just as often with HbA1c levels >8.0% as with HbA1c levels <7.0%. These data do not support the strategy of "raising the HbA1c" as being an effective approach for hypoglycemia prevention in older adults with T1D. In addition to acutely altered mental status, hypoglycemia is associated with an increased risk for falls leading to fractures, car accidents, emergency room (ER) visits, hospitalizations, and mortality resulting in substantial societal costs. The occurrence of hypoglycemia, hypoglycemia unawareness and fear of hypoglycemia have adverse effects on overall QOL of both individuals with T1D and their families.

While continuous glucose monitoring (CGM) technology alone has the potential to be beneficial in reducing hypoglycemia in older patients, our preliminary data from the Wireless Innovations for Seniors with Diabetes Mellitus (WISDM) trial shows a majority of patients still have frequent hypoglycemia even when using CGM. Thus, knowledge of CGM alone may not be sufficient to avoid hypoglycemia in this population. Predictive low-glucose suspend algorithms have particular promise when the primary goal is hypoglycemia avoidance rather than glucose reduction. Whether the added complexity of closed loop systems provides additional glycemic benefit is not known. There is a critical need to determine whether automated insulin delivery can reduce hypoglycemia in the older adult population with T1D.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: Randomized crossover trial with three 12-week crossover periods (CLC during one period, PLGS during one period, and SAP therapy (control) during one period) preceded by a run-in phase.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized Cross-over Clinical Trial to Assess the Efficacy of Closed-loop Control (CLC) and Predictive Low-glucose Suspend (PLGS) Compared With Sensor-augmented Pump Therapy (SAP) Among Older Adults With Type 1 Diabetes
Estimated Study Start Date : December 2019
Estimated Primary Completion Date : January 2022
Estimated Study Completion Date : June 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Closed Loop Control
The CLC intervention arm will utilize the Tandom t:slim X2 with Control-IQ Technology and Dexcom G6 CGM
Device: Dexcom G6 CGM

The system components include the t:slim X2 with Control-IQ Technology and the Dexcom CGM G6. The modular control algorithm has a safety supervision module that limits insulin delivery to prevent hypoglycemia at all times. The algorithm gradually decreases hyperglycemia from bedtime to reach a target of 120 mg/dL by waking time. During awake hours, the control algorithm attempts to maintain glucose within a target range (112.5 to 160 mg/dL) with meal time insulin boluses delivered based on usual bolus procedures undertaken by patients on an insulin pump (Hybrid closed loop).

The system components include the t:slim X2 with with Basal-IQ Technology and the Dexcom CGM G6. The PLGS System is able to stop and resume basal insulin delivery automatically in response to predicted or low sensor glucose values, thereby reducing the incidence and duration of hypoglycemic episodes. The pump includes the hypoglycemia minimization strategy that will issue insulin delivery commands.

Other Names:
  • Tandom t:slim X2 with Control-IQ Technology
  • Tandom t:slim X2 with Basal-IQ Technology

Active Comparator: Predictive Low Glucose Suspend
The PLGS intervention arm will utilize the Tandom t:slim X2 with Basal-IQ Technology and Dexcom G6 CGM
Device: Dexcom G6 CGM

The system components include the t:slim X2 with Control-IQ Technology and the Dexcom CGM G6. The modular control algorithm has a safety supervision module that limits insulin delivery to prevent hypoglycemia at all times. The algorithm gradually decreases hyperglycemia from bedtime to reach a target of 120 mg/dL by waking time. During awake hours, the control algorithm attempts to maintain glucose within a target range (112.5 to 160 mg/dL) with meal time insulin boluses delivered based on usual bolus procedures undertaken by patients on an insulin pump (Hybrid closed loop).

The system components include the t:slim X2 with with Basal-IQ Technology and the Dexcom CGM G6. The PLGS System is able to stop and resume basal insulin delivery automatically in response to predicted or low sensor glucose values, thereby reducing the incidence and duration of hypoglycemic episodes. The pump includes the hypoglycemia minimization strategy that will issue insulin delivery commands.

Other Names:
  • Tandom t:slim X2 with Control-IQ Technology
  • Tandom t:slim X2 with Basal-IQ Technology

Active Comparator: Sensor-Augmented Pump
The control arm will utilize the t:slim Dexcom G6 enabled pump without CLC or PLGS features
Device: Dexcom G6 CGM

The system components include the t:slim X2 with Control-IQ Technology and the Dexcom CGM G6. The modular control algorithm has a safety supervision module that limits insulin delivery to prevent hypoglycemia at all times. The algorithm gradually decreases hyperglycemia from bedtime to reach a target of 120 mg/dL by waking time. During awake hours, the control algorithm attempts to maintain glucose within a target range (112.5 to 160 mg/dL) with meal time insulin boluses delivered based on usual bolus procedures undertaken by patients on an insulin pump (Hybrid closed loop).

The system components include the t:slim X2 with with Basal-IQ Technology and the Dexcom CGM G6. The PLGS System is able to stop and resume basal insulin delivery automatically in response to predicted or low sensor glucose values, thereby reducing the incidence and duration of hypoglycemic episodes. The pump includes the hypoglycemia minimization strategy that will issue insulin delivery commands.

Other Names:
  • Tandom t:slim X2 with Control-IQ Technology
  • Tandom t:slim X2 with Basal-IQ Technology




Primary Outcome Measures :
  1. CGM Measured Time <70 mg/dL [ Time Frame: 12 weeks for each arm of the crossover ]
    Percentage of sensor glucose values <70 mg/dL


Secondary Outcome Measures :
  1. Hypoglycemia [ Time Frame: 12 weeks for each arm of the crossover ]
    Percentage of values <54 mg/dL

  2. Hypoglycemia [ Time Frame: 12 weeks for each arm of the crossover ]
    Frequency of CGM-measured hypoglycemic events

  3. Glucose Control [ Time Frame: 12 weeks for each arm of the crossover ]
    Mean glucose

  4. Glucose Control [ Time Frame: 12 weeks for each arm of the crossover ]
    Percentage of values 70 to 180 mg/dL

  5. Glucose Control [ Time Frame: 12 weeks for each arm of the crossover ]
    HbA1c

  6. Hyperglycemia [ Time Frame: 12 weeks for each arm of the crossover ]
    Percentage of values >250 mg/dL

  7. Hyperglycemia [ Time Frame: 12 weeks for each arm of the crossover ]
    Percentage of values >180 mg/dL

  8. Glycemic Variability [ Time Frame: 12 weeks for each arm of the crossover ]
    Coefficient of variation


Other Outcome Measures:
  1. Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability) [ Time Frame: 12 weeks for each arm of the crossover ]
    Diabetic ketoacidosis (DKA), as defined by the Diabetes Control and Complications Trial (DCCT)

  2. Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability) [ Time Frame: 12 weeks for each arm of the crossover ]
    Severe clinical hypoglycemic events such that the participant required assistance from another person to actively administer carbohydrate, glucagon, or engage in other resuscitative actions; note severe hypoglycemia could be considered both and efficacy and safety outcome

  3. Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability) [ Time Frame: 12 weeks for each arm of the crossover ]
    All other reported adverse events

  4. Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability) [ Time Frame: 12 weeks for each arm of the crossover ]
    Unanticipated adverse device effects

  5. Patient Reported Questionnaires [ Time Frame: 12 weeks for each arm of the crossover ]
    Assessments of diabetes distress

  6. Patient Reported Questionnaires [ Time Frame: 12 weeks for each arm of the crossover ]
    Assessments of hypoglycemic fear

  7. Patient Reported Questionnaires [ Time Frame: 12 weeks for each arm of the crossover ]
    Assessments of quality of life



Information from the National Library of Medicine

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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Clinical diagnosis of type 1 diabetes with age at onset < 40 years or age of onset >= 40 years and a C-peptide level at any time of < 0.6 ng/mL with simultaneous glucose level 80-225 mg/dL
  2. Age ≥ 65 years old
  3. T1D Duration of at least 1 year
  4. HbA1c < 10.0% from point of care or local lab at time of screening visit
  5. Insulin regimen involves basal/bolus insulin via insulin pump or multiple daily injections
  6. 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)
  7. Familiarity with and willingness to use a carbohydrate ratio for meal boluses
  8. Willing to use study devices and automated insulin delivery features
  9. Participant is independently managing his/her diabetes with respect to insulin administration and glucose monitoring (may include assistance from spouse or other caregiver)
  10. Participant understands the study protocol and agrees to comply with it
  11. Participant comprehends written and spoken English
  12. At least 85% of CGM readings available during the CGM run-in period
  13. At least 2% of time during CGM run-in period with sensor glucose levels < 70 mg/dL

Exclusion Criteria:

  1. Use of predictive low-glucose suspend technology or hybrid closed loop insulin deliver in the past 3 months
  2. Clinical diagnosis of dementia or severe cognitive impairment that would preclude ability to use devices (mild cognitive impairment is not an exclusion)
  3. Severe vision impairment that would prohibit use of the devices
  4. A condition, which in the opinion of the investigator or designee, would put the participant or study at risk, including any contraindication to the use of any of the study devices per FDA labeling
  5. Known adhesive allergy or skin reaction during the run-in pre-randomization phase that would preclude participation in the randomized trial
  6. Concurrent use of any non-insulin glucose-lowering agent other than metformin (including GLP-1 agonists, Symlin, DPP-4 inhibitors, SGLT-2 inhibitors, sulfonylureas)
  7. Stage 4 or 5 renal disease or most recent GFR < 30 ml/min/m2 from local lab within the past 6 months
  8. The presence of a significant medical or psychiatric condition or use of a medication that in the judgment of the investigator may affect completion of any aspect of the protocol, or is likely to be associated with life expectancy of <1 year

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04016662


Contacts
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Contact: Alandra Verdejo, MPH 8139758690

Locations
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United States, Florida
AdventHealth Diabetes Institute
Orlando, Florida, United States, 32803
United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
United States, Pennsylvania
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
Jaeb Center for Health Research
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
DexCom, Inc.
Tandem
University of Minnesota - Advanced Research and Diagnostic Laboratory
Mayo Clinic
University of Pennsylvania
AdventHealth Diabetes Institute
Washington State University
Investigators
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Principal Investigator: Kellee Miller, PhD Jaeb Center for Health Research

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Responsible Party: Jaeb Center for Health Research
ClinicalTrials.gov Identifier: NCT04016662     History of Changes
Other Study ID Numbers: CLC in Older Adults
First Posted: July 11, 2019    Key Record Dates
Last Update Posted: July 16, 2019
Last Verified: July 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No

Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs