- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06325202
Closed Loop and Education for Hypoglycemia Awareness Restoration (CLEAR)
Closed Loop and Education for Hypoglycemia Awareness Restoration (CLEAR), Conducted by the Impaired Awareness of Hypoglycemia Consortium (IAHC)
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Individuals with IAH exhibit blunted symptomatic and CR hormonal responses to hypoglycemia and, as such, have an impaired ability to respond to hypoglycemia. Thus, rates of severe hypoglycemia are up to 6-fold greater in those affected. Intensive management of T1D is necessary in preventing long-term complications, but can be complicated by recurrent episodes of hypoglycemia which lead to and sustain the CRR deficits of IAH. Technologies such as continuous glucose monitoring (CGM) and hybrid closed-loop (HCL) systems can reduce severe hypoglycemia (and also may reduce IAH) but the ability of technology to reverse impaired CRR (as assessed with experimental hypoglycemia clamp) remains unclear. Behavioral and psycho-educational interventions targeting knowledge/skills gaps, as well as particular cognitions and behaviors driving recurrent hypoglycemia, can also reduce severe hypoglycemia and improve awareness. No studies have compared technology with such behavioral interventions in terms of assessing their impact on IAH or the CRR (as a primary outcome). Unanswered questions include the degree of reduction in hypoglycemia required to restore awareness. Furthermore, participants may respond to different interventions according to their characteristics. For example, it remains unclear whether older individuals benefit from such interventions since they usually are excluded from studies. Therefore, there is an urgent need to determine effective interventions that can reverse IAH in a large representative population of adults with T1D and IAH. The investigators propose to study the effect of specific interventions aimed at restoring
- the CRR (tested via an experimental hypoglycemia clamp procedure)
- hypoglycemia awareness (self-reported via the Towler Questionnaire during the experimental hypoglycemia clamp procedure)
The study will use a Sequential Multiple Assignment Randomized Trial (SMART) design. At baseline, all participants who are HCL naïve will be randomized to HCL or Usual Care (UC) plus brief education (My HypoCOMPaSS) with a follow-up of two years. UC will consist of real-time continuous glucose monitoring (CGM) and insulin delivery via pump or multiple daily injections. Participants who fail to increase their CRR at 12 months will be randomized, or assigned, to a second intervention consisting of a small-group educational program focusing on motivations and unhelpful cognitions acting as barriers to hypoglycemia avoidance (HARPdoc). At baseline, all participants who are HCL non-naïve will be randomized to optimized HCL or HCL plus My HypoCOMPaSS; those with non-responsive CRR at 12 months will be randomized to either continue HCL (on the basis they need a longer period to reverse impaired CRR and total symptomatic responses) or to the HARPdoc intervention. Participants randomized to an HCL device are expected to wear the device continually, as well as a CGM. The My HypoCOMPaSS education requires 4-5 hours of training, whereas, the HARPdoc education requires four training sessions of seven hours each during weeks 1,2,3, and 6.
The specific aims and hypotheses are as follows:
Aim 1: To determine the effect on CRR (epinephrine increase ≥ 125 pg/ml over baseline) and total symptom responses (Towler Questionnaire increase ≥ 20% over baseline) during a hyperinsulinemic-hypoglycemic clamp procedure (glucose < 50 mg/dl) after 12 months of HCL versus Usual Care plus My HypoCOMPaSS Educational Intervention among adults with T1D and IAH who have never used HCL therapy previously.
Hypothesis 1: At 12 months, those allocated to Usual Care plus My HypoCOMPaSS will be more likely to have improved CRR and total symptomatic responses than those allocated to HCL.
Aim 2: To determine the effect on CRR and total symptom responses at 12 months of HCL plus My HypoCOMPaSS versus HCL alone among adults with T1D and IAH who are currently using HCL therapy prior to entering the study.
Hypothesis 2: At 12 months, those allocated to HCL plus My HypoCOMPaSS will be more likely to have improved hypoglycemic awareness and improved CRR than those using HCL alone.
Aim 3: To determine the durability of effect over 24 months of the intervention that improves CRR at 12 months among adults with type 1 diabetes and IAH at baseline.
Hypothesis 3: At 24 months, CRR will improve further among those who had restored CRR at 12 months.
Aim 4. To determine the effect on hypoglycemic awareness (Towler Questionnaire increase ≥ 20% over baseline) and CRR (epinephrine increase ≥ 125 pg/ml over baseline) during a hyperinsulinemic hypoglycemic clamp procedure at 24 months of an in-depth educational program (HARPdoc), initiated throughout months 12-24, among adults with T1D and IAH at baseline, for whom the intervention allocated at baseline did not restore CRR at 12 months.
Hypothesis 4: At 24 months, those allocated to HARPdoc for months 12-24 months will be more likely to have improved hypoglycemic awareness and CRR than those who continue with the therapy allocated at baseline.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Abid Kazi, PhD
- Phone Number: 320036 717-531-0003
- Email: akazi@pennstatehealth.psu.edu
Study Contact Backup
- Name: Venus Grella, MPH
- Phone Number: 343413 717-531-0003
- Email: vgrella@pennstatehealth.psu.edu
Study Locations
-
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Victoria
-
Fitzroy, Victoria, Australia, 3065
- University of Melbourne
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Contact:
- Katrin Brown
- Phone Number: 61 3 9231 2574
- Email: katie.brown@unimelb.edu.au
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Contact:
- Catriona Sims
- Phone Number: 61 3 9231 2574
- Email: catriona.sims@unimelb.edu.au
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Principal Investigator:
- David O'Neal, MD
-
-
-
-
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Leicester, United Kingdom, LE5 4PW
- University of Leicester
-
Contact:
- Andrew Kingsnorth
- Phone Number: 44 116-258-4874
- Email: a.kingsnorth@leicester.ac.uk
-
Principal Investigator:
- Pratik Choudhary, MBBS
-
Sheffield, United Kingdom, S10 2RX
- University of Sheffield
-
Contact:
- Simon Heller, MD
- Phone Number: 44 114-215-9009
- Email: s.heller@sheffield.ac.uk
-
Principal Investigator:
- Simon Heller, MD
-
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California
-
La Jolla, California, United States, 92037
- University of California, San Diego
-
Contact:
- Jeremy H Pettus, MD
- Phone Number: 858-246-2160
- Email: jpettus@ucsd.edu
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Principal Investigator:
- Jeremy H Pettus, MD
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Florida
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Orlando, Florida, United States, 32804
- AdventHealth
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Principal Investigator:
- Richard E Pratley, MD
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Principal Investigator:
- Anna Casu, MD
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Contact:
- Keri Whitaker
- Phone Number: 407-303-2519
- Email: keri.whitaker@adventhealth.com
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Kentucky
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Lexington, Kentucky, United States, 40508
- University of Kentucky
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Contact:
- Simon Fisher, MD, PhD
- Phone Number: 859-562-0473
- Email: Simon.Fisher@uky.edu
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Principal Investigator:
- Simon Fisher, MD, PhD
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Minnesota
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Minneapolis, Minnesota, United States, 55455
- University of Minnesota
-
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Pennsylvania
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Philadelphia, Pennsylvania, United States, 19104
- University of Pennsylvania
-
Contact:
- Cornelia (Ginger) Dalton-Bakes
- Phone Number: 215-746-2085
- Email: corneliv@pennmedicine.upenn.edu
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Principal Investigator:
- Michael R Rickels, MD, MS
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Clinical diagnosis of type 1 diabetes
- Gold Score or Clarke Score ≥ 4 (highly associated with IAH)
- Random non-fasting C-peptide < 200 pmol/L
- Diabetes duration ≥ 10 years
- HbA1c < 10.5%
- Total Daily Insulin Dose of < 1 unit/kg
- Ability to read and speak English (because validated non-English versions of the cognitive tests and the educational interventions are not available)
Exclusion Criteria:
- Medical conditions that limit participation in study activities, as determined by the PI (including but not limited to cognitive dysfunction, reduced hearing, reduced vision, cancer under active treatment, untreated angina, organ failure)
- Active alcohol or drug abuse (as defined by DSM criteria of either 1) recurrent use of alcohol/drugs resulting in a failure to fulfill major role obligations at work, school, or home, 2) recurrent alcohol/drug use in situations in which it is physically hazardous, or 3) recurrent alcohol or drug-related legal problems)
- Social determinants of health that limit participation in study activities, as determined by the PI (including but not limited to homelessness, food insecurity, inadequate social support)
- Seizure disorder unrelated to hypoglycemia associated seizures, unless documented seizure-free for >12 months and on a stable regimen of anti-convulsant therapy
- Skin conditions that would preclude the use of a CGM
- Super-physiologic exposure to steroids within one month of enrollment
- eGFR < 45 mL/min/1.73 m2
- History of bariatric surgery that irreversibly alters gut innervation and structure
- Hyper- or hypokalemia (serum potassium >5.5 or <3.5 mmol/L)*
- Hemoglobin < 10 g/dL*
- Medical condition that requires intermittent or continuous use of glucocorticoids at greater than physiological replacement doses
- Pregnancy, plan for pregnancy, or breast feeding
- Abnormal thyroid function tests of clinical significance, as determined by PI*
- Liver transaminases > 3 times the upper limit of normal*
- Hospitalization for mental illness in last year
History of adrenalectomy
- At discretion of the PI, laboratory tests may be repeated once. If the participant is not eligible after the second attempt, then the participant. The participant may be screened again.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Sequential Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: current HCL non-user: HCL x 24 months
Hybrid closed loop device over a 24-month period for individuals currently not using a hybrid closed loop device
|
Omnipod 5 and Medtronic 780G are hybrid closed loop devices that provide automated insulin delivery.
|
Experimental: current HCL non-user: HCL x 12 months, then HCL x an additional 12 months
Hybrid closed loop device over a 12-month period for individuals currently not using a hybrid closed loop device, and then a hybrid closed loop device for an additional 12 months
|
Omnipod 5 and Medtronic 780G are hybrid closed loop devices that provide automated insulin delivery.
|
Experimental: current HCL non-user: HCL x 12 months, then HCL + HARPdoc x 12 months
Hybrid closed loop device over a 12-month period for individuals currently not using a hybrid closed loop device, then a hybrid closed loop device plus HARPdoc education for an additional 12 months
|
Omnipod 5 and Medtronic 780G are hybrid closed loop devices that provide automated insulin delivery.
The HARPdoc program targets cognitions around hypoglycemia that act as barriers to hypoglycemia avoidance and recovery of awareness using motivational and cognitive approaches, delivered by diabetes educators, trained and supported by a clinical psychologist, in small group format.
|
Active Comparator: current HCL non-user: Usual Care and My HypoCOMPaSS x 12 months, then HCL x 12 months
Usual Care and My HypoCOMPaSS education over 12 months for individuals currently not using a hybrid closed loop device, then hybrid closed loop device for 12 months
|
Omnipod 5 and Medtronic 780G are hybrid closed loop devices that provide automated insulin delivery.
My HypoCOMPaSS is a brief, standardized psycho-educational program delivered in small groups.
Facilitated discussions focus on advocating rigorous avoidance of hypoglycemia while maintaining time in target glycemic range.
|
Active Comparator: current HCL non-user: Usual Care and My HypoCOMPaSS x 24 months
Usual Care and My HypoCOMPaSS education over 24 months for individuals currently not using a hybrid closed loop device
|
My HypoCOMPaSS is a brief, standardized psycho-educational program delivered in small groups.
Facilitated discussions focus on advocating rigorous avoidance of hypoglycemia while maintaining time in target glycemic range.
|
Experimental: current HCL user: HCL x 24 months
Hybrid closed loop device over a 24-month period for individuals currently using a hybrid closed loop device
|
Omnipod 5 and Medtronic 780G are hybrid closed loop devices that provide automated insulin delivery.
|
Experimental: current HCL user: HCL x 12 months, then HCL x an additional 12 months
Hybrid closed loop device over a 12-month period for individuals currently using a hybrid closed loop device, and then a hybrid closed loop device for an additional 12 months
|
Omnipod 5 and Medtronic 780G are hybrid closed loop devices that provide automated insulin delivery.
|
Experimental: current HCL user: HCL x 12 months, then HCL + HARPdoc x 12 months
Hybrid closed loop device over a 12-month period for individuals currently using a hybrid closed loop device, then a hybrid closed loop device plus HARPdoc education for an additional 12 months
|
Omnipod 5 and Medtronic 780G are hybrid closed loop devices that provide automated insulin delivery.
The HARPdoc program targets cognitions around hypoglycemia that act as barriers to hypoglycemia avoidance and recovery of awareness using motivational and cognitive approaches, delivered by diabetes educators, trained and supported by a clinical psychologist, in small group format.
|
Active Comparator: current HCL user: HCL and My HypoCOMPaSS x 12 months, then HCL x 12 months
Hybrid closed loop device and My HypoCOMPaSS education over 12 months for individuals currently using a hybrid closed loop device, then hybrid closed loop device for 12 months
|
Omnipod 5 and Medtronic 780G are hybrid closed loop devices that provide automated insulin delivery.
My HypoCOMPaSS is a brief, standardized psycho-educational program delivered in small groups.
Facilitated discussions focus on advocating rigorous avoidance of hypoglycemia while maintaining time in target glycemic range.
|
Active Comparator: current HCL user: HCL + My HypoCOMPaSS x 12 months, then HCL + My HypoCOMPaSS + HARPDOC x 12 months
Hybrid closed loop device and My HypoCOMPaSS education over 12 months for individuals currently using a hybrid closed loop device, then hybrid closed loop device plus My HypoCOMPaSS eduction + HARPdoc education for 12 months
|
Omnipod 5 and Medtronic 780G are hybrid closed loop devices that provide automated insulin delivery.
The HARPdoc program targets cognitions around hypoglycemia that act as barriers to hypoglycemia avoidance and recovery of awareness using motivational and cognitive approaches, delivered by diabetes educators, trained and supported by a clinical psychologist, in small group format.
My HypoCOMPaSS is a brief, standardized psycho-educational program delivered in small groups.
Facilitated discussions focus on advocating rigorous avoidance of hypoglycemia while maintaining time in target glycemic range.
|
Experimental: current HCL user: HCL + My HypoCOMPaSS x 24 months
Hybrid closed loop device plus My HypoCOMPaSS education over a 24-month period for individuals currently using a hybrid closed loop device
|
Omnipod 5 and Medtronic 780G are hybrid closed loop devices that provide automated insulin delivery.
My HypoCOMPaSS is a brief, standardized psycho-educational program delivered in small groups.
Facilitated discussions focus on advocating rigorous avoidance of hypoglycemia while maintaining time in target glycemic range.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
epinephrine (pg/ml)
Time Frame: measured during the clamp studies at 0 (baseline), 12, and 24 months
|
a change in epinephrine (pg/ml) that exceeds 125 pg/ml between (1) 12 months and baseline, and (2) 24 months and baseline
|
measured during the clamp studies at 0 (baseline), 12, and 24 months
|
Towler questionnaire
Time Frame: measured during the clamp studies at 0 (baseline), 12, and 24 months
|
the Towler questionnaire consists of 12 questions each on a 0-6 Likert scale; a change in the questionnaire that exceeds 20% between (1) 12 months and baseline, and (2) 24 months and baseline
|
measured during the clamp studies at 0 (baseline), 12, and 24 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
glucose infusion rate
Time Frame: measured during the clamp studies at 0 (baseline), 12, and 24 months
|
glucose infusion rate
|
measured during the clamp studies at 0 (baseline), 12, and 24 months
|
HbA1c
Time Frame: measured during the clamp studies at 0 (baseline), 12, and 24 months
|
glycated hemoglobin
|
measured during the clamp studies at 0 (baseline), 12, and 24 months
|
% of time with sensor hypoglycemia <70 mg/dL
Time Frame: measured during the four weeks prior to each clamp study at 0 (baseline), 12, and 24 months
|
% of time with hypoglycemia <70 mg/dL determined from the continuous glucose monitor (CGM) sensor
|
measured during the four weeks prior to each clamp study at 0 (baseline), 12, and 24 months
|
% of time with sensor hypoglycemia <54 mg/dL
Time Frame: measured during the four weeks prior to each clamp study at 0 (baseline), 12, and 24 months
|
% of time with hypoglycemia <54 mg/dL determined from the continuous glucose monitor (CGM) sensor
|
measured during the four weeks prior to each clamp study at 0 (baseline), 12, and 24 months
|
number of hypoglycemia events
Time Frame: measured during the four weeks prior to each clamp study at 0 (baseline), 12, and 24 months
|
number of hypoglycemia events determined from the continuous glucose monitor (CGM) sensor
|
measured during the four weeks prior to each clamp study at 0 (baseline), 12, and 24 months
|
% time with sensor glucose in range
Time Frame: measured during the four weeks prior to each clamp study at 0 (baseline), 12, and 24 months
|
% time with glucose in range determined from the continuous glucose monitor (CGM) sensor
|
measured during the four weeks prior to each clamp study at 0 (baseline), 12, and 24 months
|
sensor glucose coefficient of variation
Time Frame: measured during the four weeks prior to each clamp study at 0 (baseline), 12, and 24 months
|
sensor glucose coefficient of variation determined from the continuous glucose monitor (CGM) sensor
|
measured during the four weeks prior to each clamp study at 0 (baseline), 12, and 24 months
|
sensor use as the average numbers of days per week
Time Frame: measured during the four weeks prior to each clamp study at 0 (baseline), 12, and 24 months
|
sensor use as the average number of days per week determined from the continuous glucose monitor (CGM) sensor
|
measured during the four weeks prior to each clamp study at 0 (baseline), 12, and 24 months
|
glycemia risk index
Time Frame: measured during the four weeks prior to each clamp study at 0 (baseline), 12, and 24 months
|
glycemia risk index determined from the continuous glucose monitor (CGM) sensor
|
measured during the four weeks prior to each clamp study at 0 (baseline), 12, and 24 months
|
Trail Making Test - Part B
Time Frame: measured during the clamp studies at 0 (baseline), 12, and 24 months
|
amount of time required to complete the Trail Making Test - Part B
|
measured during the clamp studies at 0 (baseline), 12, and 24 months
|
Four Choice Reaction Time
Time Frame: measured during the clamp studies at 0 (baseline), 12, and 24 months
|
Four Choice Reaction Time, which measures reaction time and motor coordination
|
measured during the clamp studies at 0 (baseline), 12, and 24 months
|
sleep duration
Time Frame: measured during the two weeks prior to each clamp study at 0 (baseline), 12, and 24 months
|
sleep duration determined from an activity monitor smartwatch
|
measured during the two weeks prior to each clamp study at 0 (baseline), 12, and 24 months
|
sleep quality
Time Frame: measured during the two weeks prior to each clamp study at 0 (baseline), 12, and 24 months
|
sleep quality determined by an activity monitor smartwatch
|
measured during the two weeks prior to each clamp study at 0 (baseline), 12, and 24 months
|
24-hour step count
Time Frame: measured during the two weeks prior to each clamp study at 0 (baseline), 12, and 24 months
|
24-hour step count determined by an activity monitor smartwatch
|
measured during the two weeks prior to each clamp study at 0 (baseline), 12, and 24 months
|
exercise bouts
Time Frame: measured during the two weeks prior to each clamp study at 0 (baseline), 12, and 24 months
|
exercise bouts determined by an activity monitor smartwatch
|
measured during the two weeks prior to each clamp study at 0 (baseline), 12, and 24 months
|
resting heart rate
Time Frame: measured during the two weeks prior to each clamp study at 0 (baseline), 12, and 24 months
|
resting heart rate determined by an activity monitor smartwatch
|
measured during the two weeks prior to each clamp study at 0 (baseline), 12, and 24 months
|
heart rate during exercise
Time Frame: measured during the two weeks prior to each clamp study at 0 (baseline), 12, and 24 months
|
heart rate during exercise determined by an activity monitor smartwatch
|
measured during the two weeks prior to each clamp study at 0 (baseline), 12, and 24 months
|
heart rate variability
Time Frame: measured during the two weeks prior to each clamp study at 0 (baseline), 12, and 24 months
|
heart rate variability determined by an activity monitor smartwatch
|
measured during the two weeks prior to each clamp study at 0 (baseline), 12, and 24 months
|
Hypo-METRICS questionnaire
Time Frame: measured two weeks prior to each clamp study at 0 (baseline), 12, and 24 months
|
Hypo-METRICS questionnaire, a Person-Reported Outcome Measure (PROM) specific to hypoglycemia
|
measured two weeks prior to each clamp study at 0 (baseline), 12, and 24 months
|
Hypoglycemia Fear Survey-II
Time Frame: measured two weeks prior to each clamp study at 0 (baseline), 12, and 24 months
|
Hypoglycemia Fear Survey-II, a Person-Reported Outcome Measure (PROM) specific to hypoglycemia
|
measured two weeks prior to each clamp study at 0 (baseline), 12, and 24 months
|
Attitudes to Awareness of Hypoglycaemia
Time Frame: measured two weeks prior to each clamp study at 0 (baseline), 12, and 24 months
|
Attitudes to Awareness of Hypoglycaemia, a Person-Reported Outcome Measure (PROM) specific to hypoglycemia
|
measured two weeks prior to each clamp study at 0 (baseline), 12, and 24 months
|
Type 1 Diabetes Distress Scale
Time Frame: measured two weeks prior to each clamp study at 0 (baseline), 12, and 24 months
|
Type 1 Diabetes Distress Scale, a Person-Reported Outcome Measure (PROM) specific to hypoglycemia
|
measured two weeks prior to each clamp study at 0 (baseline), 12, and 24 months
|
Diabetes Self-Management Questionnaire
Time Frame: measured two weeks prior to each clamp study at 0 (baseline), 12, and 24 months
|
Diabetes Self-Management Questionnaire, a Person-Reported Outcome Measure (PROM) specific to hypoglycemia
|
measured two weeks prior to each clamp study at 0 (baseline), 12, and 24 months
|
Diabetes Management Experiences Questionnaire
Time Frame: measured two weeks prior to each clamp study at 0 (baseline), 12, and 24 months
|
Diabetes Management Experiences Questionnaire, a Person-Reported Outcome Measure (PROM) specific to hypoglycemia
|
measured two weeks prior to each clamp study at 0 (baseline), 12, and 24 months
|
PROMIS Sleep Disturbance - Short Form 8a
Time Frame: measured two weeks prior to each clamp study at 0 (baseline), 12, and 24 months
|
PROMIS Sleep Disturbance - Short Form 8a
|
measured two weeks prior to each clamp study at 0 (baseline), 12, and 24 months
|
12-Item Hypoglycemia Impact Profile
Time Frame: measured two weeks prior to each clamp study at 0 (baseline), 12, and 24 months
|
12-Item Hypoglycemia Impact Profile, a Person-Reported Outcome Measure (PROM) specific to hypoglycemia
|
measured two weeks prior to each clamp study at 0 (baseline), 12, and 24 months
|
EQ-5D-5L
Time Frame: measured two weeks prior to each clamp study at 0 (baseline), 12, and 24 months
|
EQ-5D-5L, a quality-of-life scale with 5 dimensions
|
measured two weeks prior to each clamp study at 0 (baseline), 12, and 24 months
|
device-related adverse events
Time Frame: throughout the duration of the 24 months of follow-up
|
device-related adverse events
|
throughout the duration of the 24 months of follow-up
|
diabetic ketoacidosis (DKA) events
Time Frame: throughout the duration of the 24 months of follow-up
|
diabetic ketoacidosis (DKA) events
|
throughout the duration of the 24 months of follow-up
|
major adverse cardiovascular events (MACE)
Time Frame: throughout the duration of the 24 months of follow-up
|
major adverse cardiovascular events (MACE)
|
throughout the duration of the 24 months of follow-up
|
all-cause mortality
Time Frame: throughout the duration of the 24 months of follow-up
|
all-cause mortality
|
throughout the duration of the 24 months of follow-up
|
geometric mean of plasma glucagon
Time Frame: measured during the clamp studies at 0 (baseline), 12, and 24 months
|
geometric mean of plasma glucagon
|
measured during the clamp studies at 0 (baseline), 12, and 24 months
|
geometric mean of plasma pancreatic polypeptide
Time Frame: measured during the clamp studies at 0 (baseline), 12, and 24 months
|
geometric mean of plasma pancreatic polypeptide
|
measured during the clamp studies at 0 (baseline), 12, and 24 months
|
geometric mean of plasma free fatty acids
Time Frame: measured during the clamp studies at 0 (baseline), 12, and 24 months
|
geometric mean of plasma free fatty acids
|
measured during the clamp studies at 0 (baseline), 12, and 24 months
|
Hypoglycemic Confidence Scale
Time Frame: measured two weeks prior to each clamp study at 0 (baseline), 12, and 24 months
|
Hypoglycemic Confidence Scale, a Person-Reported Outcome Measure (PROM) specific to hypoglycemia, the range is 0 through 27 and higher scores correspond to higher confidence
|
measured two weeks prior to each clamp study at 0 (baseline), 12, and 24 months
|
Hospital Anxiety and Depression Scale
Time Frame: measured two weeks prior to each clamp study at 0 (baseline), 12, and 24 months, the range is 0 through 42 and higher scores correspond to higher anxiety and depression
|
Hospital Anxiety and Depression Scale
|
measured two weeks prior to each clamp study at 0 (baseline), 12, and 24 months, the range is 0 through 42 and higher scores correspond to higher anxiety and depression
|
severe hypoglycemic events, self-reported on a CLEAR data collection form
Time Frame: throughout the duration of the 24 months of follow-up
|
severe hypoglycemic events, self-reported on a CLEAR data collection form
|
throughout the duration of the 24 months of follow-up
|
number of participants with hospitalizations
Time Frame: throughout the duration of the 24 months of follow-up
|
number of participants with hospitalizations
|
throughout the duration of the 24 months of follow-up
|
number of participants with emergency room (ER) visits
Time Frame: throughout the duration of the 24 months of follow-up
|
number of participants with emergency room (ER) visits
|
throughout the duration of the 24 months of follow-up
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Vernon M Chinchilli, PhD, Penn State College of Medicine
- Study Chair: Elizabeth R Seaquist, MD, University of Minnesota
- Study Chair: Simon Heller, MD, University of Sheffield
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- STUDY00020946
- 1U01DK135126 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
The release data sets will be stored at the NIDDK Central Repository.
The release data sets will de-identified, i.e., they will not contain names, social security numbers, addresses, phone numbers, health care records, and/or similar protected health information. In addition, the release data sets will have an anonymous study ID that is linked to an individual only in the participant records at the Biostatistics Research Center at the Penn State College of Medicine.
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
- ANALYTIC_CODE
- CSR
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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Shanghai Changzheng HospitalRecruitingBrittle Type 1 Diabetes MellitusChina
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Capillary Biomedical, Inc.CompletedDiabetes Mellitus, Type 1 | Type 1 Diabetes | Type 1 Diabetes Mellitus | Diabetes Mellitus, Insulin-Dependent, 1Australia
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Spiden AGDCB Research AGRecruitingType 1 Diabetes Mellitus | Type 1 Diabetes Mellitus With Hypoglycemia | Type 1 Diabetes Mellitus With HyperglycemiaSwitzerland
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Hoffmann-La RocheRoche DiagnosticsCompletedDiabetes Mellitus Type 2, Diabetes Mellitus Type 1Germany
Clinical Trials on Omnipod 5 or Medtronic 780G
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University of MilanRecruitingType 1 DiabetesItaly
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Sheba Medical CenterAssaf-Harofeh Medical Center; Tel-Aviv Sourasky Medical Center; Wolfson Medical... and other collaboratorsRecruitingType 1 Diabetes | Child, OnlyIsrael
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Universitaire Ziekenhuizen KU LeuvenRecruitingDiabetes Mellitus, Type 1Belgium
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Fundacion para la Investigacion Biomedica del Hospital...Completed
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Insulet CorporationRecruitingType 1 DiabetesUnited States
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Insulet CorporationActive, not recruiting
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Jagiellonian UniversityMedtronic Poland Spółka z ograniczoną odpowiedzialnością; University of RzeszowUnknownDiabetes Mellitus, Type 1
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Seoul National University HospitalMedtronicRecruitingType 1 DiabetesKorea, Republic of
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Insulet CorporationActive, not recruitingDiabetes Mellitus, Type 1Belgium, France, United Kingdom
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Imperial College LondonRecruitingType 1 Diabetes | GastroparesisUnited Kingdom