Advanced Technologies & Treatments for Diabetes

[harryx1]

Conference Calendar - The 13th International Conference on Advanced Technologies & Treatments for Diabetes


cslide.ctimeetingtech.com/attd2020/attendee/confcal/show/session/76




INSIGHTS TO IMPROVE USE OF TECHNOSPHERE® INSULIN PROVIDED BY BLUHALE, A DIGITAL DIABETES TOOL

Lecture Time

08:01 - 08:02

Presenter

Benoit Adamo, United States of America

Authors

Chad Smutney, United States of AmericaJohn Pocreva, United States of AmericaBenoit Adamo, United States of AmericaMarina David, United States of AmericaJonathan Manoukian, United States of America

Abstract

Background and Aims

Technosphere® Insulin (TI) is an inhaled insulin with a rapid rate of onset and short duration of action that has been shown to improve glycemic control in adult patients with diabetes mellitus (DM). Unfamiliarity with TI dosing has limited use of TI among prescribers and patients. BluHale is a digital diabetes platform capable of enhancing user and prescriber experience with TI. A cartridge color detector embedded within BluHale V2.0 monitors usage of TI. A proof-of-concept single-patient study involving BluHale V2.0 was performed to provide insights into TI usage.

Methods

A 63-year-old male patient with type 1 DM who had been using mealtime TI for 3 years utilized BluHale V2.0 during TI self-administration for 21 days. Blood glucose levels were monitored via continuous glucose monitoring (CGM) and overlaid with dose monitoring output from BluHale V2.0.

Results

The volunteer self-administered TI while using BluHale V2.0 for 21 days, during which the average number of TI administrations was 6 per day. Rapid reductions in glucose levels immediately following administration were observed. A dose-recommendation algorithm was developed and retroactively applied to the BluHale/CGM data based on blood glucose levels. The data suggested the volunteer often administered TI at a dose or time that was late or when glucose levels were already out of range.

Conclusions

BluHale V2.0 technology provides the ability to visualize dosing information overlaid with CGM data. This technology has the potential to improve dosing behaviors and reveal nonoptimal dosing behaviors, allowing patients to optimize their time in range.

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PATIENT TRAINER EXPERIENCE WITH BLUHALE V1.0 FOR PROPER TECHNOSPHERE® INSULIN ADMINISTRATION

Lecture Time

08:02 - 08:03

Presenter

Nadia Zaveri, United States of America

Authors

Elizabeth Gentry, United States of AmericaAlex White, United States of AmericaKimberly Pohoski, United States of AmericaMarina David, United States of AmericaJonathan Manoukian, United States of AmericaNadia Zaveri, United States of America

Abstract

Background and Aims

Digital technologies are transforming how patients with diabetes mellitus (DM) monitor and manage their disease. Technosphere® Insulin (TI) is an inhaled rapid-acting insulin that can improve glycemic control in adult patients with DM. BluHale V1.0 is a device that can be mounted on the TI inhaler to enhance patient training on proper inhalation technique. Trainers responsible for teaching inhalation technique to patients newly prescribed TI were surveyed to evaluate the utility of BluHale as a training tool.

Methods

Certified diabetes educators (CDEs) and medical assistants (MAs) involved in patient training for use of TI evaluated the usefulness of BluHale as a training device. Trainers assessed their level of confidence in their own training skills, before and after using the device, on a scale of 1 (not confident at all) to 5 (very confident). Additionally, trainers evaluated the level of confidence of the individuals they trained before and after the trainees used BluHale.

Results

Forty-five trainers (CDEs, 49%; MAs, 51%) were surveyed. On average, trainers reported increased training confidence after they used BluHale (pre-use, 3.7; post-use, 4.6) and believed that trained individuals were more confident performing proper inhalation of TI after the trainees used BluHale (pre-use, 3.4; post-use, 4.7). Additionally, most trainers (80%) believed that BluHale use may reduce the time needed to train patients.

Conclusions

BluHale V1.0 is a useful tool that can enhance insulin administration training for patients prescribed TI, which may help patients be more successful when using TI.


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SAFETY AND PHARMACOKINETICS OF TECHNOSPHERE INSULIN IN PEDIATRIC PATIENTS

Lecture Time

08:04 - 08:05

Presenter

David Kendall, United States of America

Authors

Mashall Grant, United States of AmericaJohn Krueger, United States of AmericaMark Fineman, United States of AmericaGaurav Sharma, United States of AmericaFrank Pompilio, United States of AmericaDavid Kendall, United States of America

Abstract

Background and Aims

Technosphere Insulin (TI), an ultra-rapid, short-acting inhaled insulin, provides glycemic control in patients with diabetes. This ongoing, 2-part, open-label, interventional study (NCT02527265) aims to assess efficacy and safety of TI in children aged 4 to 17 years with type 1 diabetes (T1D) who are receiving a stable regimen of basal-bolus insulin.

Methods

Part 1, a single-arm study, includes evaluation of insulin pharmacokinetics (PK) after a single prandial dose of TI (4, 8, or 12 U), followed by a 4-week titration period. Approximately 46 patients will be enrolled across 3 cohorts: cohorts 1 (13-17 years), 2 (8-12 years), and 3 (4-7 years).

Results

Initial PK results from cohort 1 demonstrated insulin metabolism similar to that in adult patients receiving TI. Insulin concentrations rapidly increased in the first 30 minutes after TI treatment and returned to baseline by 120 minutes for the 4-, 8-, and 12-U doses. Mean postprandial glucose levels decreased within 1-hour postdose for the 8- and 12-U doses. Seven patients developed treatment-related cough of mild (6 events) or moderate (1 event) severity; 7 patients experienced a total of 41 hypoglycemic events; no patients required the assistance of another person to administer corrective carbohydrates. No clinically relevant declines in pulmonary function were reported. Two patients discontinued because of adverse events (cough, diabetic ketoacidosis).

Conclusions

These data will help determine the appropriate age range for inclusion and recommended dosing for part 2, which will be a 1-year efficacy and safety study.



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EFFECTIVE TREATMENT OF PATIENTS WITH UNCONTROLLED TYPE 2 DIABETES ON MULTIPLE DIABETES MEDICATIONS BY ADDING MEALTIME ULTRA-RAPID TECHNOSPHERE INSULIN

Lecture Time

08:06 - 08:07

Presenter

Philip Levin, United States of America

Authors

Philip Levin, United States of AmericaJanet Snell-bergeon, United States of AmericaTim Vigers, United States of AmericaLaura Pyle, United States of AmericaLee A. Bromberger, United States of America

Abstract

Background and Aims

Technosphere Insulin (TI), an inhaled insulin with ultra-rapid onset and short duration of action, may improve patient outcomes. This study aimed to determine real-world dosing requirements, safety, and efficacy of TI use in patients with uncontrolled type 2 diabetes (T2D).

Methods

Twenty patients with T2D inadequately controlled with oral/injectable combination therapy in a real-world setting received TI added to current therapy. Dosing started at TI 4 U and was adjusted weekly on the basis of postprandial glucose levels. HbA1c and CGM profiles were collected at baseline and 12 weeks.

Results

Final mealtime doses were 18, 17, and 19 U for breakfast, lunch, and dinner, respectively. Mealtime TI resulted in significant reductions from baseline at week 12 in HbA1c (-1.6%, P<0.0001; Table) and mean daily glucose (-41.0 mg/dL, P<0.0002) and increased time in range (TIR) by 23.5%, with a 1.5% increase in hypoglycemia and no severe hypoglycemia (Table). Patients averaging ≥20 U per meal had a 92% increase in TIR , with no substantial increase in hypoglycemia (1.9%). Weight loss of 0.91 kg occurred (not significant).

Table.







Primary endpoint (SD), %

Baseline

(N=20)

Week 12

(N=20)

Change

Mean HbA1c

9.0 (1.0)

7.4 (0.6)

-1.6

P<0.0001

CGM data







Time in range

42.2 (22.2)

65.7 (16.2)

+23.5 (22.6)

P<0.0002

Time <70 mg/dL

1.1 (2.3)

2.6 (2.5)

+1.5 (1.3)

P<0.01

Time >180 mg/dL

57.3 (23.3)

32.5 (16.9)

-24.8 (23.1)

P<0.0002

CGM, continuous glucose monitoring; HbA1c, glycated hemoglobin.

Conclusions

Addition of mealtime TI significantly improved overall glycemic control in patients previously uncontrolled with oral/injectable diabetes medications.



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[goyocafe]

Bluehale 2.0? I must have missed 1.0.

[centralcoastinvestor]

Why do the lecture times only show 1 minute?  Is that some kind of placeholder.  It is impossible to make a presentation in 1 minute.

[goyocafe]

So if the notion is to overlay Bluehale 2.0 data on CGM data, Afrezza will be free to offer an API (application programming interface) to every CGM manufacturer to build into their data service.

[mnholdem]

I understand that there have been some modifications to the device that would enable it to transmit the cartridge size being inhaled. That would be essential for future apps, I would think.

[mango]

BIG conference event for MannKind! Happy to see so many presentations!

[mango]

Levin Study had significant results!

Final mealtime doses were 18, 17, and 19 U for breakfast, lunch, and dinner, respectively. Mealtime TI resulted in significant reductions from baseline at week 12 in HbA1c (-1.6%, P<0.0001; Table) and mean daily glucose (-41.0 mg/dL, P<0.0002) and increased time in range (TIR) by 23.5%, with a 1.5% increase in hypoglycemia and no severe hypoglycemia (Table). Patients averaging ≥20 U per meal had a 92% increase in TIR , with no substantial increase in hypoglycemia (1.9%). Weight loss of 0.91 kg occurred (not significant).


SIGNIFICANT reductions in A1c...

And, to complement what we have previously seen many times, weight loss did occur with use of Afrezza!

Lastly, this Levin Study shows once again that increased Afrezza dosing (in this case as much as =>20 units per meal), did not show any significant increase in hypoglycemia!

Not going to see these results with RAAs!

[rfogel]

When he says the patients "received TI added to current therapy," does that mean that they were uncontrolled but had not tried to use conventional RAA therapy?

[sayhey24]

Feb 19, 2020 16:37:07 GMT -5 mango said:

BIG conference event for MannKind! Happy to see so many presentations!

Thanks for posting.  These are the "February" presentations Mike spoke to on the Q3 call.  It will be interesting to see how the Q4 call goes on 2/25 a few days after this conference  concludes.  

[sayhey24]

Feb 19, 2020 20:11:29 GMT -5 rfogel said:

When he says the patients "received TI added to current therapy," does that mean that they were uncontrolled but had not tried to use conventional RAA therapy?

Insulin is the last step in the step program.  Prior to being put on an RAA they will usually be put on a basal.  Insulin is dangerous and requires needles.  It is also seen as a last resort and the PWD is in the final stage.

Afrezza on the other hand should be the first treatment.  If so the other meds would never be required.  It would have been interesting if Levin had an arm which took the PWD off their current meds and only used afrezza.  I think even fewer hypos would have been seen and TIR would have been similar.

[agedhippie]

Feb 19, 2020 20:11:29 GMT -5 rfogel said:

When he says the patients "received TI added to current therapy," does that mean that they were uncontrolled but had not tried to use conventional RAA therapy?

Yes, it means exactly that.

This study repeats the mistake of not having a control arm using RAA. If you want to illustrate the benefit of Afrezza then show it against RAA like STAT did, but with CGMs like this study. That way you have CGM graphs for both sides and a picture is worth 1,000 words.

[bill]

Feb 19, 2020 17:42:52 GMT -5 mango said:

Levin Study had significant results!

Final mealtime doses were 18, 17, and 19 U for breakfast, lunch, and dinner, respectively. Mealtime TI resulted in significant reductions from baseline at week 12 in HbA1c (-1.6%, P<0.0001; Table) and mean daily glucose (-41.0 mg/dL, P<0.0002) and increased time in range (TIR) by 23.5%, with a 1.5% increase in hypoglycemia and no severe hypoglycemia (Table). Patients averaging ≥20 U per meal had a 92% increase in TIR , with no substantial increase in hypoglycemia (1.9%). Weight loss of 0.91 kg occurred (not significant).


SIGNIFICANT reductions in A1c...

And, to complement what we have previously seen many times, weight loss did occur with use of Afrezza!

Lastly, this Levin Study shows once again that increased Afrezza dosing (in this case as much as =>20 units per meal), did not show any significant increase in hypoglycemia!

Not going to see these results with RAAs!

mango - Do results like that suggest that MNKD may need to consider producing additional cartridge types beyond 12U, e.g., 16U and/or 20U so users have to only use one cartridge? My thought is that if they don't do that, the treatment cost per month could get outrageous...

[mango]

Feb 20, 2020 14:33:39 GMT -5 bill said:

Feb 19, 2020 17:42:52 GMT -5 mango said:

Levin Study had significant results!

Final mealtime doses were 18, 17, and 19 U for breakfast, lunch, and dinner, respectively. Mealtime TI resulted in significant reductions from baseline at week 12 in HbA1c (-1.6%, P<0.0001; Table) and mean daily glucose (-41.0 mg/dL, P<0.0002) and increased time in range (TIR) by 23.5%, with a 1.5% increase in hypoglycemia and no severe hypoglycemia (Table). Patients averaging ≥20 U per meal had a 92% increase in TIR , with no substantial increase in hypoglycemia (1.9%). Weight loss of 0.91 kg occurred (not significant).


SIGNIFICANT reductions in A1c...

And, to complement what we have previously seen many times, weight loss did occur with use of Afrezza!

Lastly, this Levin Study shows once again that increased Afrezza dosing (in this case as much as =>20 units per meal), did not show any significant increase in hypoglycemia!

Not going to see these results with RAAs!

mango - Do results like that suggest that MNKD may need to consider producing additional cartridge types beyond 12U, e.g., 16U and/or 20U so users have to only use one cartridge? My thought is that if they don't do that, the treatment cost per month could get outrageous...

Some here, and maybe elsewhere, have suggested MannKind make a larger cartridge, but I have no idea. My guess is, MannKind is looking at it closely.