Using an Artificial Pancreas System in Older Adult Type 1 Diabetes Mellitus Patients (T1DM AP)
16 novembre 2022 mis à jour par: Yale University
Restoring Brain Metabolism and Function in Older Adult T1DM Patients Using an AP System
To demonstrate that a new insulin pump system can prevent low glucose episodes and improve brain function in aged Type 1 diabetes mellitus subjects.
Aperçu de l'étude
Statut
Résilié
Les conditions
Intervention / Traitement
Description détaillée
The goals of this proposal are to implement a Close-Loop/Artificial Pancreas (CL/AP) system in older patients with type 1 diabetes mellitus (T1DM) in order to reverse brain metabolic adaptations and restore metabolic sensitivity, hypoglycemia awareness and appropriate hormonal counterregulatory responses (CRR).
For purposes of this study we are looking to enroll aged T1DM subjects under insulin pump treatment.
Type d'étude
Interventionnel
Inscription (Réel)
7
Phase
- N'est pas applicable
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Lieux d'étude
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Connecticut
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New Haven, Connecticut, États-Unis, 06510
- Yale New Haven Hospital
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Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
50 ans à 75 ans (Adulte, Adulte plus âgé)
Accepte les volontaires sains
Non
Sexes éligibles pour l'étude
Tout
La description
Inclusion Criteria:
- Provide signed and dated informed consent form
- Male or female
- Age 50-75 years (at least 50% over the age of 65)
- T1DM (>20 years duration)
- C-peptide undetectable
- HbA1c of < 8%
- Insulin pump therapy
- History of frequent hypoglycemia with unawareness (defined as 2 or more episodes of severe hypoglycemia within one year requiring assistance) and 2 or more glucose values < 54 mg/dL during the week of Continuous Glucose Monitoring (CGM) (iPRO monitor, Medtronic) prior to enrollment
- BMI <27 kg/m2
- Good general health as evidenced by medical history and blood screening
- Willing to comply with all study procedures and be available for the duration of the study
- Willing to fast for a limited time period on the morning of a clamp study
Exclusion Criteria:
- Significant diabetic complications (untreated proliferative retinopathy, creatinine ≥1.5 mg/dl, urinary albumin levels 300 mg/day, autonomic neuropathy, painful peripheral neuropathy)
- Significant alcohol intake and vegetarian diet since both are known to have an impact on counterregulation and brain metabolism
- Any contraindications for MRI scanning, including presence of metallic implants or claustrophobia.
- Heavy exercise on a regular basis (i.e. marathon runners)
- Known allergic reactions to components of the study product(s)
- Treatment with another investigational drug or other intervention
- Active infection including hepatitis C, hepatitis B, HIV
- Any past or current history of alcohol or substance abuse
- Psychiatric or neurological disorders under active treatment
- Baseline hemoglobin < 10.5 g/dL in females, or < 12.5 g/dL in males. Blood donation within 30 days of the study
- History of coagulopathy or medical condition requiring long-term anticoagulant therapy (low-dose aspirin treatment is allowed)
- Co-existing cardiac, liver, and kidney disease
- Abnormal liver function tests
- Women that are on oral contraceptives, post-menopausal, pregnant (as assessed by pregnancy test that will be performed on female participants at reproductive age), or lactating.
- Any medical condition or medication that, in the opinion of the investigators, will interfere with the safe completion of the study or study outcomes
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Seul
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Comparateur actif: CL/AP system
To improved glycemic control and strict avoidance of hypoglycemia via 8-week use of a CL/AP system (closed-loop/artificial pancreas) reverses brain metabolic adaptations in older adult T1DM patients.
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CL/AP system enabled insulin pump/CGM combination
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Comparateur placebo: usual care
Subjects in this control group will continue their usual diabetic care (insulin pump therapy) along with CGM recording.
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usual diabetic care (insulin pump therapy) along with CGM recording
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Brain Alternate Fuel Uptake
Délai: Baseline to 8 - 10 weeks
|
Change in brain alternate fuel uptake under hypoglycemia was measured by assessing the percent enrichment of Glutamine 4 (Gln4). Change was measured by subtracting follow up from baseline. Astrocytic glutamine C4 enrichment is a measure of brain acetate metabolism (an alternate fuel to glucose). Previous studies have shown that in people who have been exposed to frequent hypoglycemic episodes, glutamine C4 enrichment increases. Therefore, we expected a reduction in Glutamine C4 percent enrichment in the follow up NMR scans in the intervention group who avoided frequent hypoglycemic episodes through the CL/AP system. In addition, there is no specific cut off value used for Glutamine C4 enrichment, rather a change or reduction was expected and noted." |
Baseline to 8 - 10 weeks
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Change in Cognitive Function: MOCA
Délai: Baseline to 8-10 weeks
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The Montreal Cognitive Assessment (MoCA) was designed as a rapid screening instrument for mild cognitive dysfunction.
It assesses different cognitive domains: attention and concentration, executive functions, memory, language, visuoconstructional skills, conceptual thinking, calculations, and orientation.
Time to administer the MoCA is approximately 10 minutes.
The total possible score is 30 points; a score of 26 or above is considered normal.
Change was calculated by subtracting follow up from baseline.
https://www.parkinsons.va.gov/resources/MoCA-Instructions-English.pdf
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Baseline to 8-10 weeks
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Change in Cognitive Function: Trail Test A
Délai: Baseline to 8-10 weeks
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Trail making test (TMT) A is a test of visual attention and task switching.
It provides information about visual search speed, speed of processing and executive function.
Time is measured in seconds.
The typical average time to complete the test is 29 seconds, a "deficient" performance would be >78 seconds; most people are able to complete in 90 seconds.
Change was calculated by subtracting follow up from baseline.
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Baseline to 8-10 weeks
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Change in Cognitive Function: Trail Test B
Délai: Baseline to 8-10 weeks
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Trail making test (TMT) B is a test of visual attention and task switching.
It provides information about visual search speed, speed of processing and executive function.
Time will be measured in seconds.
The typical average time to complete the test is 75 seconds, a "deficient" performance would be >273 seconds; most people are able to complete in 180 seconds.
Change was calculated by subtracting follow up from baseline.
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Baseline to 8-10 weeks
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Change in Cognitive Function: Grooved Pegboard Test
Délai: Baseline to 8-10 weeks
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The grooved pegboard test is a manipulative dexterity test that assessed psychomotor speed, fine motor control, and rapid-visual motor coordination.
It consists of a small board of holes with randomly positioned slots.
Pegs with a key along one side must be rotated to match the hole before they can be inserted.
The task was completed using the dominant hand.
Time was measured in seconds.
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Baseline to 8-10 weeks
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Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Les enquêteurs
- Chercheur principal: Raimund Herzog, MD, Yale School of Medicine Department of Endocrinology
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Réel)
1 novembre 2017
Achèvement primaire (Réel)
28 août 2019
Achèvement de l'étude (Réel)
28 août 2019
Dates d'inscription aux études
Première soumission
9 novembre 2017
Première soumission répondant aux critères de contrôle qualité
22 novembre 2017
Première publication (Réel)
27 novembre 2017
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
18 novembre 2022
Dernière mise à jour soumise répondant aux critères de contrôle qualité
16 novembre 2022
Dernière vérification
1 novembre 2022
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 2000020059
- 1R01DK101984-01A1 (Subvention/contrat des NIH des États-Unis)
- 1DP3DK112227-01 (Subvention/contrat des NIH des États-Unis)
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Non
Étudie un produit d'appareil réglementé par la FDA américaine
Oui
produit fabriqué et exporté des États-Unis.
Oui
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .