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Hybrid Closed Loop Insulin Delivery System in Hypoglycemia (Aim2)

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ClinicalTrials.gov Identifier: NCT03215914
Recruitment Status : Recruiting
First Posted : July 12, 2017
Last Update Posted : September 11, 2018
Sponsor:
Collaborator:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
Michael R. Rickels, MD, MS, University of Pennsylvania

Brief Summary:
Can a type 1 diabetic adult avoid low glucoses and regain hypoglycemia awareness using a hybrid closed loop insulin delivery system? Involvement is 22 months (13 visits) and includes a 4-week Screening Phase and an 18-month Intervention Phase. Participants will undergo 3 Hyperinsulinemic Clamps done at: Baseline (before starting the device and after completing the screening), 6 months (after using the device 6 months), and after using the device for 18 months. This metabolic testing will allow us to measure improvement in hypoglycemia awareness.

Condition or disease Intervention/treatment Phase
Type1diabetes Hypoglycemia Unawareness Nocturnal Hypoglycemia Hypoglycemia Night Hypoglycemia Device: MiniMed 670G system Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 18 participants
Intervention Model: Single Group Assignment
Intervention Model Description: Open label, single-arm trial of the effect of hybrid closed-loop insulin delivery on glucose counterregulatory mechanisms assessed by the stepped- hyperinsulinemic hypoglycemic clamp in patients with long standing type 1 diabetes complicated by hypoglycemia unawareness.
Masking: None (Open Label)
Masking Description: No masking.
Primary Purpose: Treatment
Official Title: Effect of Hybrid Closed-Loop Insulin Delivery on Glucose Counterregulation in Long Standing Type 1 Diabetes: A Proof of Concept, Mechanistic, Single-Arm Clinical Trial
Actual Study Start Date : August 1, 2017
Estimated Primary Completion Date : December 31, 2021
Estimated Study Completion Date : December 31, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Subjects with type 1 diabetes using MiniMed 670G system
Eligible subjects with type 1 diabetes will initiate hybrid closed-loop insulin delivery based on interstitial glucose monitoring via the MiniMed 670G system according to Medtronic's labeling. This system combines subject-delivered pre-meal boluses with automatic interprandial insulin delivery that includes automated functions for both predictive and threshold suspension of insulin delivery intended to minimize exposure to glucose levels < 70 mg/dl.
Device: MiniMed 670G system
Eligible subjects with type 1 diabetes will initiate hybrid closed-loop insulin delivery based on interstitial glucose monitoring via the MiniMed 670G system according to Medtronic's labeling. This system combines subject-delivered pre-meal boluses with automatic interprandial insulin delivery that includes automated functions for both predictive and threshold suspension of insulin delivery intended to minimize exposure to glucose levels < 70 mg/dl.




Primary Outcome Measures :
  1. Endogenous Glucose Production [ Time Frame: After 6 months of hybrid closed-loop insulin delivery. ]
    The primary outcome measure will be endogenous glucose production in response to insulin-induced hypoglycemia.


Secondary Outcome Measures :
  1. Endogenous Glucose Production [ Time Frame: After 18 months of hybrid closed-loop insulin delivery. ]
    The primary outcome measure will be endogenous glucose production in response to insulin-induced hypoglycemia.



Information from the National Library of Medicine

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Ages Eligible for Study:   25 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male and female subjects age 25 to 70 years.
  • Subjects who are able to provide written informed consent and to comply with the procedures of the study protocol.
  • Clinical history compatible with type 1 diabetes with disease onset < 40 years of age and insulin dependent for > 10 years.
  • Absent C-peptide (< 0.3 ng/ml).
  • Involvement in intensive diabetes management defined as the use of basal-bolus insulin analog delivery by multi-dose injection (MDI) or continuous subcutaneous insulin infusion (CSII) together with self-monitoring of blood glucose values more than 3 times daily with or without continuous glucose monitoring (CGM) under the direction of an endocrinologist, diabetologist, or diabetes nurse practitioner with at least 3 clinical evaluations during the previous 12 months.
  • Hypoglycemia unawareness manifested by a Clarke score of 4 or more AND at least 1 of the following: HYPO score greater than or equal to the 90th percentile (1047); OR marked glycemic lability defined by a glycemic lability index (LI) score greater than or equal to the 90th percentile (433 mmol/l2/h•wk-1); OR a composite of a HYPO score greater than or equal to the 75th percentile (423) and a LI greater than or equal to the 75th percentile (329) (Senior et al., 2015).
  • Documented > 5% time spent in the hypoglycemic range (glucose < 60 mg/dl) by 7 day real- time or blinded CGM; at least one episode of hypoglycemic during the 7 days must occur overnight.

Exclusion Criteria:

  • BMI ≥ 30 kg/m2.
  • Insulin requirement of ≥ 1.0 units/kg•day.
  • HbA1c ≥ 10%.
  • Untreated proliferative diabetic retinopathy.
  • Uncontrolled hypertension: systolic blood pressure > 160 mmHg or diastolic blood pressure > 100 mmHg.
  • Active cardiovascular disease
  • Abnormal kidney function: eGFR < 60 ml/min/1.73 m2.
  • Abnormal liver function: persistent elevation of liver function tests > 1.5 times the upper limit of normal.
  • Untreated hypothyroidism, Addison's disease, or Celiac disease.
  • Anemia: baseline hemoglobin concentration < 11 g/dl in women and < 12 g/dl in men.
  • Presence of a seizure disorder not related to prior severe hypoglycemia.
  • Use of glucocorticoids greater than 5 mg of prednisone daily, or an equivalent physiologic dose of hydrocortisone.
  • For female participants of child-bearing potential: Positive pregnancy test, presently breast-feeding, or unwillingness to use effective contraceptive measures for the duration of study participation. Oral contraceptives, intra-uterine devices, Norplant®, Depo-Provera®, and barrier devices with spermicide are acceptable contraceptive methods; condoms used alone are not acceptable.
  • Treatment with any anti-diabetic medication other than insulin within 4 weeks of enrollment.
  • Use of any investigational agents within 4 weeks of enrollment.
  • Any medical condition that, in the opinion of the PI, will interfere with the safe completion of the study

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): NCT03215914


Contacts
Contact: Cornelia V Dalton Bakes (215) 746-2085 cornelia.dalton-bakes@uphs.upenn.edu
Contact: Jack N Eiel (215) 746-2081 jack.eiel@uphs.upenn.edu

Locations
United States, Pennsylvania
Clinical and Translational Research Center, Hospital of University of Pennsylvania Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Ginger (Cornelia V) Dalton-Bakes    215-746-2085    cornelia.dalton-bakes@uphs.upenn.edu   
Contact: Amy Peleckis    215-746-2084    amy.peleckis@uphs.upenn.edu   
Principal Investigator: Michael R Rickels, M.D., M.S.         
Rodebaugh Diabetes Center, University of Pennsylvania Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Ginger (Cornelia V) Bakes    215-746-2085    cornelia.dalton-bakes@uphs.upenn.edu   
Contact: Amy Peleckis    215-746-2084    amy.peleckis@uphs.upenn.edu   
Principal Investigator: Michael R. Rickels, M.D., M.S.         
Sub-Investigator: Mark H. Schutta, M.D.         
University of Pennsylvania - Institute for Diabetes, Obesity and Metabolism Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Ginger (Cornelia V) Bakes, CRC    215-746-2085    cornelia.dalton-bakes@uphs.upenn.edu   
Contact: Amy Peleckis, NP    215 746-2084    amy.peleckis@uphs.upenn.edu   
Principal Investigator: Michael R Rickels, MD., MS         
Sponsors and Collaborators
University of Pennsylvania
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Investigators
Principal Investigator: Michael R Rickels, MD University of Pennsylvania

Additional Information:
Responsible Party: Michael R. Rickels, MD, MS, Associate Professor of Medicine, University of Pennsylvania
ClinicalTrials.gov Identifier: NCT03215914     History of Changes
Other Study ID Numbers: 827557
2R01DK091331 ( U.S. NIH Grant/Contract )
First Posted: July 12, 2017    Key Record Dates
Last Update Posted: September 11, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: It is not yet known if there will be any further plan to make IPD available besides the Informed Consent. Study is just beginning.
Supporting Materials: Informed Consent Form (ICF)
Time Frame: Immediately
Access Criteria:

To request an informed consent document please contact:

Ginger Bakes, CCRC: Cornelia.dalton-bakes@uphs.upenn.edu


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
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: Yes

Keywords provided by Michael R. Rickels, MD, MS, University of Pennsylvania:
Closed loop insulin delivery system
Insulin Pump
Glycemic control
Glucose Counterregulation

Additional relevant MeSH terms:
Diabetes Mellitus, Type 1
Hypoglycemia
Unconsciousness
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Consciousness Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Insulin, Globin Zinc
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs