[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT06918977":3,"trial-entities:NCT06918977":106,"trial-summary:NCT06918977":109},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":20,"study_type":23,"primary_purpose":24,"phases":25,"enrollment_info":27,"interventions":30,"primary_outcomes":42,"secondary_outcomes":47,"sex":51,"minimum_age":52,"maximum_age":53,"healthy_volunteers":15,"eligibility_criteria":54,"std_ages":69,"locations":72,"central_contacts":98,"overall_officials":103,"references":104,"see_also_links":105},"NCT06918977","HP-00113553","Improving Glycemic Control With Telemedicine and Smart Insulin Pens","Evaluation of a Novel Telemedicine Clinic for Patients With DM2 on Multiple Daily Insulin (MDI) Regimens","RECRUITING","2028-05-30","2026-02","2026-02-10","2026-01-30","University of Maryland, Baltimore","OTHER",false,"Almost 40% of veterans have diabetes, the proposed research may improve clinical care among veterans with diabetes. In this application we are going to examine whether utilizing Smart Insulin pens (SIPs) with CGMs and telemedicine is a better tool for managing diabetes compared to traditional insulin pens, CGMs and telemedicine, leading to improved blood sugar control and better clinical outcomes.","Diabetes is affecting millions of Americans. High glucose levels lead to complications such as heart attacks, stroke or blindness. Reducing high glucose levels may unfortunately lead to very low glucose values-hypoglycemia, a condition that can lead to loss of consciousness or even death. Both of these conditions, high and low glucose levels, can therefore lead to visits to the Emergency department or hospitalizations. In fact, patients with diabetes have frequent admissions to the hospital. Additionally, many of them are admitted again, immediately or in less than 30 days after hospital discharge.\n\nMost patients with diabetes are monitoring their glucose values with finger-stick glucose testing. Continuous Glucose Monitors (CGM)s are new devices that can monitor glucose continuously (every couple of minutes) without the need of finger-stick glucose testing. Similar to the glucometers, CGM devices can record glucose values, which can then be obtained by the clinicians, who can help them to modify DM medications.\n\nIn addition to using CGM devices for diabetes management, smart insulin pens can be used in order to help with diabetes control. These devices can store and transfer data to the medical doctors, making them aware about the patients' glucose values.\n\nMoreover there are different health solutions available to manage patients including mobile health and telemedicine, which can help combining and transferring these data remotely. Briefly, telemedicine is a way to deliver healthcare where providers and patients communicate through alternative methods ( for example, telephone or other electronic method) instead of traditional in-person office visits. Using telemedicine to replace some routine office visits can improve access to healthcare.\n\nSubjects will be randomly assigned in 2 groups: One group will include patients with SIPs, CGMs and telemedicine and the other group will use traditional insulin pens, CGMs and telemedicine",[19],"Diabetes Mellitus",[19,21,22],"CGM device","Smart Insulin Pen","INTERVENTIONAL","PREVENTION",[26],"NA",{"count":28,"type":29},50,"ESTIMATED",[31,37],{"type":32,"name":33,"description":34,"armGroupLabels":35},"DEVICE","InPen Smart insulin pen","InPen is a reusable pen injector which allows the user to dial the desired dose of insulin to be administered. The dose calculator a component of the InPen app calculates an insulin dose or carbohydrate intake based on user entered data. Prior to use, the patient -specific target blood glucose, insulin-to-carbohydrate ratio, and insulin sensitivity parameters are to be programmed into the software.",[36],"Intervention Group",{"type":14,"name":38,"description":39,"armGroupLabels":40},"traditional\u002Fstandard insulin pen","personal prescribed insulin pen",[41],"Control Group",[43],{"measure":44,"description":45,"timeFrame":46},"Change in hyperglycemia","This will be evaluated by decrease HbA1c","3 months",[48],{"measure":44,"description":49,"timeFrame":50},"This will be evaluated by decrease in HbA1c","6 months","ALL","18 Years",null,{"inclusion":55,"exclusion":58,"raw_text":68},[56,57],"≥18 years of age","MDI insulin treated (receiving MDI for at least 3 months prior to the study)",[59,60,61,62,63,64,65,66,67],"DM patients not treated with MDI for at least 3 months (i.e diet only, any combination of non-insulin antidiabetic drugs only, basal insulin only or bolus\u002Fshort acting insulin only)","Patients with DM at the time of screening on insulin pumps","Pregnant patients","Patients with extensive skin disease or allergies that preclude wearing the CGM sensor","Patients who have end-stage renal disease requiring dialysis","Patients with significant psychiatric illness or any other condition rendering the subject incapable of understanding the objectives and potential consequences of the study","Patients who receive hydroxyurea or who are on long (chronic) treatment with acetaminophen","Patients who were started on non-insulin DM medications or had a dose change within 60 days or less prior to study participation","Patient does not have or not able to gain access to a smartphone which is compatible with the necessary applications for DAT","Inclusion Criteria:\n\n* ≥18 years of age\n* MDI insulin treated (receiving MDI for at least 3 months prior to the study)\n\nExclusion Criteria:\n\n* DM patients not treated with MDI for at least 3 months (i.e diet only, any combination of non-insulin antidiabetic drugs only, basal insulin only or bolus\u002Fshort acting insulin only)\n* Patients with DM at the time of screening on insulin pumps\n* Pregnant patients\n* Patients with extensive skin disease or allergies that preclude wearing the CGM sensor\n* Patients who have end-stage renal disease requiring dialysis\n* Patients with significant psychiatric illness or any other condition rendering the subject incapable of understanding the objectives and potential consequences of the study\n* Patients who receive hydroxyurea or who are on long (chronic) treatment with acetaminophen\n* Patients who were started on non-insulin DM medications or had a dose change within 60 days or less prior to study participation\n* Patient does not have or not able to gain access to a smartphone which is compatible with the necessary applications for DAT",[70,71],"ADULT","OLDER_ADULT",[73,82],{"facility":74,"status":8,"city":75,"state":76,"zip":77,"country":78,"geoPoint":79},"Baltimore VA Maryland Center","Baltimore","Maryland","21201","United States",{"lat":80,"lon":81},39.29038,-76.61219,{"facility":83,"status":84,"city":75,"state":76,"zip":77,"country":78,"contacts":85,"geoPoint":97},"VAMHCS, Diabetes Outpatient Clinic","NOT_YET_RECRUITING",[86,91,95],{"name":87,"role":88,"phone":89,"email":90},"Ilias Spanakis","CONTACT","617-319-9731","ispanakis@som.umaryland.edu",{"name":92,"role":88,"phone":93,"email":94},"William H Scott","410-300-7747","William.Scott5@va.gov",{"name":87,"role":96},"PRINCIPAL_INVESTIGATOR",{"lat":80,"lon":81},[99],{"name":100,"role":88,"phone":101,"email":102},"William Scott, MS","4106057000","william.scott5@va.gov",[],[],[],{"nct_id":4,"conditions":107,"biomarkers":108},[19],[],{"nct_id":4,"found":110,"summary":111,"prompt_version":121},true,{"design":112,"status":113,"heading":114,"summary":115,"follow_up":116,"word_count":117,"commitments":118,"compensation":119,"drugs_mentioned":120},"This interventional study plans to enroll 50 participants. It compares the InPen Smart insulin pen with traditional insulin pens.","completed","Improving Diabetes Control with Smart Insulin Pens and Telemedicine","This study is looking at whether using a smart insulin pen called InPen, along with continuous glucose monitors (CGMs) and telemedicine, can help people with diabetes manage their blood sugar better than using traditional insulin pens. The study aims to see if this approach leads to improved blood sugar control and better health outcomes. You might be able to join if you are at least 18 years old and have been using multiple daily insulin injections (MDI) for at least three months. The main goal is to see how much hyperglycemia (high blood sugar) changes after three months. The current status of this study is unclear, and it plans to enroll 50 participants.","Participants will be followed for changes in hyperglycemia, measured at 3 months.",113,"Not specified in the trial record.","Not stated in the trial record.",[],"v2"]