NCT05893797已完成不适用
Assessment of Participant Adherence and Glucose Control While Using a Connected Insulin Management Platform
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 36
- 试验地点
- 9
- 主要终点
- Number of Missed Bolus Doses (MBDs) Per Week
研究概览
简要总结
The main purpose of this study is to assess participant adherence and glucose control while using a connected insulin management platform. Approximately 50 participants will be enrolled in each country.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Have been diagnosed (clinically) with T1D for at least 1 year or are patients with T2D on basal bolus insulin therapy for at least 6 months
- •HbA1c ≥8% as confirmed by point-of-care test at screening
- •Are currently using the Dexcom G6 CGM or agree to start using the Dexcom G6 during the study and agree to switch to Glooko RMA
- •Are currently using Humalog ® insulin or another rapid acting insulin analogue (e.g., Apidra® , or Novorapid ® ) and agree to switch to study-provided Humalog mealtime insulin for duration of trial
- •Have been prescribed ≥3 doses of bolus insulin per day
- •Must be taking a stable insulin dose regimen (per investigator's judgement) for at least 3 months preceding study screening
- •Have in-home refrigeration for storage of insulin
排除标准
- •Previously used the Glooko RMA and/or Dexcom G6 CGM and were judged by the investigator to be non-adherent
- •Have participated, within the last 30 days, in a clinical study involving an investigational product. If the previous investigational product has a long half-life, 5 half-lives or 30 days (whichever is longer) should have passed
- •Have previously used or have been using an approved or investigational connected pen system within the 3 months prior to screening
- •Are currently breastfeeding, pregnant, or plan to become pregnant during the next 4-6 months
- •Are on ultra-rapid insulin (e.g., Fiasp or Lyumjev) or rapid acting human insulin (i.e., Humulin) for previous 3 months, at the time of screening
- •Are currently undergoing dialysis treatment or have any other medical condition which may preclude them from participating in this trial as per the investigator's judgement
- •Have vision loss or vision impairment that does not allow recognition of Glooko RMA screen features
研究组 & 干预措施
Humalog Tempo Pen With CGM Monitoring
Experimental
Study Period 1: Weeks 1 to 6
- Participants used a Sponsor-provided Humalog Tempo Pen with Tempo Smart Button (TSB), Dexcom G6 continuous glucose monitoring (CGM), and the Glooko Research Mobile App (RMA) to share insulin dose and timing data with healthcare providers (HCPs) via the Glooko HCP platform. Mealtime insulin data was masked to participants but visible to HCPs. Participants followed their usual insulin regimen and lifestyle, manually logged basal insulin and activities in the app. After 6 weeks, data was unmasked and reviewed with HCPs.
Study Period 2: Weeks 7 to 18
- Participants used the Humalog Tempo Pen with TSB, Dexcom G6 CGM, and Glooko RMA study app for 12 weeks. Insulin dose and timing data was unmasked and visible to both participants and HCPs via the Glooko RMA and HCP platform. Participants regularly upload CGM and pen data. HCPs monitor adherence and follow up as needed to ensure data transfer and CGM use.
干预措施: Insulin Lispro (Drug)
Humalog Tempo Pen With CGM Monitoring
Experimental
Study Period 1: Weeks 1 to 6
- Participants used a Sponsor-provided Humalog Tempo Pen with Tempo Smart Button (TSB), Dexcom G6 continuous glucose monitoring (CGM), and the Glooko Research Mobile App (RMA) to share insulin dose and timing data with healthcare providers (HCPs) via the Glooko HCP platform. Mealtime insulin data was masked to participants but visible to HCPs. Participants followed their usual insulin regimen and lifestyle, manually logged basal insulin and activities in the app. After 6 weeks, data was unmasked and reviewed with HCPs.
Study Period 2: Weeks 7 to 18
- Participants used the Humalog Tempo Pen with TSB, Dexcom G6 CGM, and Glooko RMA study app for 12 weeks. Insulin dose and timing data was unmasked and visible to both participants and HCPs via the Glooko RMA and HCP platform. Participants regularly upload CGM and pen data. HCPs monitor adherence and follow up as needed to ensure data transfer and CGM use.
干预措施: Tempo Smart Button (Device)
Humalog Tempo Pen With CGM Monitoring
Experimental
Study Period 1: Weeks 1 to 6
- Participants used a Sponsor-provided Humalog Tempo Pen with Tempo Smart Button (TSB), Dexcom G6 continuous glucose monitoring (CGM), and the Glooko Research Mobile App (RMA) to share insulin dose and timing data with healthcare providers (HCPs) via the Glooko HCP platform. Mealtime insulin data was masked to participants but visible to HCPs. Participants followed their usual insulin regimen and lifestyle, manually logged basal insulin and activities in the app. After 6 weeks, data was unmasked and reviewed with HCPs.
Study Period 2: Weeks 7 to 18
- Participants used the Humalog Tempo Pen with TSB, Dexcom G6 CGM, and Glooko RMA study app for 12 weeks. Insulin dose and timing data was unmasked and visible to both participants and HCPs via the Glooko RMA and HCP platform. Participants regularly upload CGM and pen data. HCPs monitor adherence and follow up as needed to ensure data transfer and CGM use.
干预措施: Dexcom G6 CGM (Device)
Humalog Tempo Pen With CGM Monitoring
Experimental
Study Period 1: Weeks 1 to 6
- Participants used a Sponsor-provided Humalog Tempo Pen with Tempo Smart Button (TSB), Dexcom G6 continuous glucose monitoring (CGM), and the Glooko Research Mobile App (RMA) to share insulin dose and timing data with healthcare providers (HCPs) via the Glooko HCP platform. Mealtime insulin data was masked to participants but visible to HCPs. Participants followed their usual insulin regimen and lifestyle, manually logged basal insulin and activities in the app. After 6 weeks, data was unmasked and reviewed with HCPs.
Study Period 2: Weeks 7 to 18
- Participants used the Humalog Tempo Pen with TSB, Dexcom G6 CGM, and Glooko RMA study app for 12 weeks. Insulin dose and timing data was unmasked and visible to both participants and HCPs via the Glooko RMA and HCP platform. Participants regularly upload CGM and pen data. HCPs monitor adherence and follow up as needed to ensure data transfer and CGM use.
干预措施: Glooko Research Mobile App (RMA) (Device)
结局指标
主要结局
Number of Missed Bolus Doses (MBDs) Per Week
时间窗: Study Period 1: Week 6 ; Study Period 2: Week 18
Missed bolus dose is defined as no insulin dose from 1 hour prior to through 1 hour after the start of a glucose excursion (meal), where a glucose excursion was defined as a greater than (\>) 70 milligrams per deciliter (mg/dL) (\>3.9 millimoles per liter \[mmol/L\]) rise within 2 hours, not preceded by a value \<70 mg/dL (\<3.9 mmol/L).
次要结局
- Mean Glucose as Measured by CGM(Study Period 1: Week 6; Study Period 2: Week 18)
- Percentage of Time in Blood Glucose (BG) Range 70 to 180 mg/dL Captured by Continuous Glucose Monitoring (CGM)(Study Period 1: Week 6; Study Period 2: Week 18)
- Percentage of Time in Hyperglycemic Range of >180 mg/dL and >250 mg/dL Captured by CGM(Study Period 1: Week 6; Study Period 2: Week 18)
- Percentage of Time in Hypoglycemic Range <54 mg/dL and 54 to 69 mg/dL Captured by CGM(Study Period 1: Week 6; Study Period 2: Week 18)
- Coefficient of Variation for Glucose(Study Period 1: Week 6; Study Period 2: Week 18)
- Number of Mistimed Bolus Dose Per Week(Study Period 1: Week 6 ; Study Period 2: Week 18)
- Total Insulin Dose Per Day(Study Period 1: Week 6; Study Period 2: Weeks 18)
- Number of Correction Bolus Dose Per Week(Study Period 1: Week 6; Study Period 2: Week 18)
- Correlation Between Missed Bolus Dose and Glycemic Outcomes [i.e., HbA1c, Time in BG Range (70-180 mg/dL), Time in Hyperglycemic Range (>250 mg/dL), and Time in Hypoglycemia (<54 mg/dL)] Using Raw CGM Integrated Data From Tempo Pen and Tempo Smart Button(Study Period 1: Week 6; Study Period 2: Week 18)
- Correlation Between Mistimed Bolus Dose and Glycemic Outcomes [i.e., HbA1c, Time in BG Range (70-180 mg/dL), Time in Hyperglycemic Range (>250 mg/dL), Time in Hypoglycemia (<54 mg/dL)] Using Raw CGM Integrated Data From Tempo Pen and Tempo Smart Button(Study Period 1: Week 6; Study Period 2: Week 18)
- Study Period 1: Participant Questionnaires (Device Satisfaction)- On Average, How Satisfied Are You With Your Current Insulin Pen?(At Baseline)
- Study Period 1: Participant Questionnaires (Device Satisfaction) - On Average, How Satisfied Are You With the Way You Manage Your Insulin Treatment on a Day-to-day Basis?(At Baseline)
- Study Period 2: Participant Questionnaires (Device Preference) - I Prefer the Connected Insulin Pen Compared to the Insulin Pen I Used Before the Study?(Study Period 2: Week 18)
- Study Period 2: Participant Questionnaires (Device Usefulness) - I Found the App Difficult to Use to Monitor my Insulin Doses(Study Period 2: Week 18)
- Study Period 2: Participant Questionnaires (Device Usefulness) - It Helped me to Forget Fewer Doses(Study Period 2: Week 18)
- Study Period 2: Participant Questionnaires (Device Usefulness) - I no Longer Had to Worry About When my Last Dose Was Injected or Not(Study Period 2: Week 18)
- Study Period 2: Participant Questionnaires (Device Usefulness) - Having All my Insulin and Glucose Data in One Place Simplified my Diabetes Management(Study Period 2: Week 18)
- Study Period 2: Participant Questionnaires (Device Usefulness): I Found the Connected Pen to be Difficult to Use(Study Period 2: Week 18)
- Study Period 2: Participant Questionnaires (Device Usefulness): The Use of the Connected Insulin Pen Reduced the Amount of Time I Spent on my Diabetes Management(Study Period 2: Week 18)
- Health Care Provider (HCP) Questionnaires (Device Satisfaction) - On Average, How Satisfied Are You With the Connected Insulin Pen Your Patients Have Been Using in the Study?(Following completion of participant's Last visit in the study (approximately 3 days after last visit on week 18))
- Health Care Provider (HCP) Questionnaires (Device Usefulness) - Offered me Objective Date on my Patients Dosing History Allowing me to Provide Appropriate Dosing Guidance(Following completion of participant's Last visit in the study (approximately 3 days after last visit on week 18))
- Health Care Provider (HCP) Questionnaires (Device Usefulness)- It Improved my Confidence in Making Appropriate Dosing Decisions(Following completion of participant's Last visit in the study (approximately 3 days after last visit on week 18))
- Health Care Provider (HCP) Questionnaires (Device Usefulness) - I Suspect That my Patients Miss Insulin Doses Regularly(Following completion of participant's Last visit in the study (approximately 3 days after last visit on week 18))
- Health Care Provider (HCP) Questionnaires (Device Usefulness)- Allowed me to Objectively Discuss Missed Doses or Mistimed Doses With my Patients(Following completion of participant's Last visit in the study (approximately 3 days after last visit on week 18))
研究者
研究点 (9)
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