Safety Evaluation of MODI, an Insulin Titration Algorithm, in Adults With Diabetes

ConditionsType 1 Diabetes (T1D)Type 2 Diabetes (T2D)

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18-80

SponsorDreaMed Diabetes

About this trial

A 13-week multi-center single-arm trial, preceded by a 2-week standard therapy phase, will be conducted to assess the safety of MODI, an insulin titration algorithm, in adults with type 1 diabetes (T1D) who use multiple daily insulin injections (MDI), or with type 2 diabetes (T2D) who use MDI, basal insulin only, or who are candidates to initiate basal insulin, in conjunction with continuous glucose monitoring (CGM).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Clinical diagnosis, based on investigator assessment, of T1D or T2D of at least 6 months duration at time of informed consent

If T1D, using MDI insulin therapy for at least 3 months prior to screening; willing to follow a mealtime insulin dosing approach during the study, using either (a) time-of-day-based dosing (breakfast, lunch, dinner) or (b) meal-size-based dosing (small, normal, large); and taking

Age at time of consent 18-80 years

HbA1c >7.5% and <12% as measured by point-of-care device or local lab at the time of screening

Disqualifiers

Use of an insulin pump within 3 months prior to informed consent

Use of mixed insulin or intermediate insulin (NPH) within the past 3 months prior to screening

Taking more than 128 units of daily basal insulin or more than 79 units in a single bolus insulin injection in the 7 days prior to screening

Any medical condition which in the opinion of the investigator, would put the participant at an unacceptable safety risk, such as untreated malignancy, unstable cardiac disease, unstable or end-stage renal disease, and/or eating disorders (i.e. anorexia/bulimia)

Trial design

Design model

Single group

Treatments tested in this trial

MODI Algorithm
Device
All participants use MODI insulin titration algorithm. Includes Diary app used to view treatment plans shared by MODI and manually log events (insulin intake, meal, physical activity and others) by participants; also includes a bolus calculator.

Treatment groups

102 Participants

are divided into 1 treatment group

Group A: MODI dose guidance, insulin titration applicationExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

CGM-measured percent time <54mg/dL

Change in CGM-measured percent time \<54 mg/dL from 2 weeks of baseline to 4 weeks prior to the dose guidance week 12 visit (non-inferiority with margin 0.5%)

Time frame

13 weeks

Secondary outcomes

HbA1c

Change in HbA1c from baseline to dose guidance week 12 visit

Time frame

13 weeks

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

DreaMed Diabetes

Lead sponsor

Jaeb Center for Health Research

Collaborator

Abbott Diabetes Care