Phase
Condition
Diabetes Prevention
Diabetes Mellitus Types I And Ii
Diabetes And Hypertension
Treatment
Tempo Smart Button
Dexcom G6 CGM
Glooko Research Medical App (RMA)
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Have been diagnosed (clinically) with T1D for at least 1 year or are patients withT2D 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 duringthe 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 Humalogmealtime 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 atleast 3 months preceding study screening
Have in-home refrigeration for storage of insulin
Exclusion
Exclusion Criteria:
Previously used the Glooko RMA and/or Dexcom G6 CGM and were judged by theinvestigator to be non-adherent
Have participated, within the last 30 days, in a clinical study involving aninvestigational product. If the previous investigational product has a longhalf-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 pensystem 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 conditionwhich may preclude them from participating in this trial as per the investigator'sjudgement
Have vision loss or vision impairment that does not allow recognition of Glooko RMAscreen features
Study Design
Connect with a study center
CHU Strasbourg-Hautepierre
Strasbourg, Alsace 67098
FranceSite Not Available
CHU de Caen Hôpital Cote de Nacre
Caen, Cedex 9 14033
FranceSite Not Available
Centre Hospitalier Sud Francilien
Corbeil-Essonnes, Île-de-France 91106
FranceSite Not Available
CHU de Besancon Hopital Jean Minjoz
Besancon Cedex, 25030
FranceSite Not Available
University Hospital Center Caen
Caen, 14000
FranceSite Not Available
Centre Hospitalier Sud Francilien-Pharmacie
Corbeil-Essonnes, 91100
FranceSite Not Available
Chu de Grenoble
Grenoble, 38700
FranceSite Not Available
Chu de Grenoble
Grenoble Cédex 9, 38043
FranceSite Not Available
CHU De Grenoble Hopital Albert Michallon
La Tronche, 38700
FranceSite Not Available
CHU de Lyon
Lyon, 69008
FranceSite Not Available
Hôpital Edouard Herriot
Lyon, 69003
FranceSite Not Available
CHU - l'Assistance Publique - Hôpitaux de Marseille
Marseille, 13005
FranceSite Not Available
Marseille Public University Hospital
Marseille, 13005
FranceSite Not Available
Centre Hospitalier Universitaire de Nice - Hôpital l'Archet
Nice, 6202
FranceSite Not Available
University Hospital Center Strasbourg
Strasbourg, 6700
FranceSite Not Available
Chu Toulouse Hotel-Dieu Saint Jacques
Toulouse Cedex, 31052
FranceSite Not Available
Groupe Hospitalier Mutualiste Les Portes du Sud
Venissieux, 69200
FranceSite Not Available
Groupe Hospitalier Mutualiste Les Portes du Sud
Vénissieux, 69200
FranceSite Not Available
Azienda Ospedaliera Universitaria Careggi
Firenze, Florence 50134
ItalySite Not Available
ASST Grande Ospedale Metropolitano Niguarda
Milan, Milano 20162
ItalySite Not Available
AO Santa Maria della Misericordia
Perugia, Umbria 06132
ItalySite Not Available
Azienda Ospedaliera Spedali Civili di Brescia
Brescia, 25123
ItalySite Not Available
Azienda ospedaliero-universitaria Mater Domini
Catanzaro, 88100
ItalySite Not Available
ASL Gallura
Olbia, 07026
ItalySite Not Available
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